Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401) · Source last updated 2024-05-07
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
6 months, 1 year, and 2 years post-transplant and at Cycles 3(Day 57), 6(Day 141), 9(Day 225), 12(Day 309), 15 (Day 393), 18(Day 477), 21(Day 561) and 24(Day 654) of maintenance therapy
What was measured
A participant's disease status is evaluated based on the International Uniform Response Criteria per protocol. Before disease progression (PD), all disease classifications including stringent complete response (sCR), complete response (CR), very good partial remission (VGPR), partial response (PR), stable disease (SD) are relative to participant's disease status at study entry. Disease status is 'Not Evaluable' when disease assessment is not required, or disease status is missing.
Analysis population: Analysis Population includes transplanted participants.
Groups in this outcome
Lenalidomide, Vaccine, and GM-CSF
Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will undergo leukapheresis and then will receive maintenance lenalidomide with myeloma vaccine and GM-CSF.
Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell will be isolated and frozen for subsequent vaccine generation.
Autologous Stem Cell Transplant: Patients will receive an autologous graft of a minimum cell dose of 2.0 x 10\^6 CD34+ cells/kg patient actual body weight per transplantation with high-dose melphalan of 200mg/m\^2 at the schedule and timing according to institutional practices.
Leukapheresis: Blood samples will be collected through a catheter in the neck or chest and leukapheresis will be performed using standard clinical procedures.
Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.
Myeloma vaccine: The target dose is 3 x 10\^6 fusion cells per vaccine. A minimum of 3 x 10\^6 total fusion cells will be required to proceed with vaccine administration. Patients will receive the DC/MM fusion vaccine on day 1 of cycles 2, 3, and 4 of lenalidomide maintenance.
GM-CSF: 100 ug GM-CSF will be given for a total of 4 days of each cycle.
Lenalidomide and GM-CSF
Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide with GM-CSF.
Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery).
Autologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10\^6 CD34+ cells/kg patient actual body weight per autologous transplantation.
Melphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m\^2 at the schedule and timing according to institutional practices.
Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.
GM-CSF: 100 ug GM-CSF will be given subcutaneously in the upper thigh and daily for a total of 4 days of each cycle.
Maintenance Lenalidomide
Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide.
Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery).
Autologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10\^6 CD34+ cells/kg patient actual body weight per autologous transplantation.
Melphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m\^2 at the schedule and timing according to institutional practices.
Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Lenalidomide, Vaccine, and GM-CSF
68
Lenalidomide and GM-CSF
37
Maintenance Lenalidomide
35
Reported measurements
Disease Status at 6 Months
Stringent Complete Response (sCR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
12
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
9
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
8
Not reported
Not reported
Not reported
Not reported
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
17
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
8
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
10
Not reported
Not reported
Not reported
Not reported
Very Good Partial Remission (VGPR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
28
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
12
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
13
Not reported
Not reported
Not reported
Not reported
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
5
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
5
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
2
Not reported
Not reported
Not reported
Not reported
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
2
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
1
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Progression (PD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Dead
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Not Evaluable
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
4
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
2
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
2
Not reported
Not reported
Not reported
Not reported
Disease Status at 12 Months
Stringent Complete Response (sCR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
18
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
8
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
9
Not reported
Not reported
Not reported
Not reported
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
18
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
8
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
9
Not reported
Not reported
Not reported
Not reported
Very Good Partial Remission (VGPR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
22
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
12
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
10
Not reported
Not reported
Not reported
Not reported
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
4
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
7
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
3
Not reported
Not reported
Not reported
Not reported
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Progression (PD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
5
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
2
Not reported
Not reported
Not reported
Not reported
Dead
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
1
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Not Evaluable
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
2
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
2
Not reported
Not reported
Not reported
Not reported
Disease Status at 24 Months
Stringent Complete Response (sCR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
17
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
7
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
9
Not reported
Not reported
Not reported
Not reported
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
13
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
6
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
10
Not reported
Not reported
Not reported
Not reported
Very Good Partial Remission (VGPR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
15
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
15
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
3
Not reported
Not reported
Not reported
Not reported
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
6
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
4
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
2
Not reported
Not reported
Not reported
Not reported
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Progression (PD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
2
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Dead
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
2
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
1
Not reported
Not reported
Not reported
Not reported
Not Evaluable
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
13
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
5
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
10
Not reported
Not reported
Not reported
Not reported
Disease Status at Cycle 3 (Day 57 Assessment)
Stringent Complete Response (sCR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
8
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
9
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
7
Not reported
Not reported
Not reported
Not reported
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
19
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
5
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
14
Not reported
Not reported
Not reported
Not reported
Very Good Partial Remission (VGPR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
35
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
15
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
11
Not reported
Not reported
Not reported
Not reported
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
5
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
6
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
2
Not reported
Not reported
Not reported
Not reported
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Progression (PD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Dead
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Not Evaluable
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
1
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
2
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
1
Not reported
Not reported
Not reported
Not reported
Disease Status at Cycle 6 (Day 141 Assessment)
Stringent Complete Response (sCR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
13
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
7
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
7
Not reported
Not reported
Not reported
Not reported
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
18
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
7
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
14
Not reported
Not reported
Not reported
Not reported
Very Good Partial Remission (VGPR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
28
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
14
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
10
Not reported
Not reported
Not reported
Not reported
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
6
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
7
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
2
Not reported
Not reported
Not reported
Not reported
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
1
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Progression (PD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
1
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Dead
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Not Evaluable
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
1
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
2
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
2
Not reported
Not reported
Not reported
Not reported
Disease Status at Cycle 9 (Day 225 Assessment)
Stringent Complete Response (sCR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
16
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
8
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
9
Not reported
Not reported
Not reported
Not reported
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
17
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
7
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
15
Not reported
Not reported
Not reported
Not reported
Very Good Partial Remission (VGPR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
24
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
13
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
7
Not reported
Not reported
Not reported
Not reported
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
6
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
7
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
2
Not reported
Not reported
Not reported
Not reported
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Progression (PD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
2
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Dead
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Not Evaluable
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
3
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
2
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
2
Not reported
Not reported
Not reported
Not reported
Disease Status at Cycle 12 (Day 309 Assessment)
Stringent Complete Response (sCR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
18
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
9
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
9
Not reported
Not reported
Not reported
Not reported
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
18
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
6
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
10
Not reported
Not reported
Not reported
Not reported
Very Good Partial Remission (VGPR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
20
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
13
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
7
Not reported
Not reported
Not reported
Not reported
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
5
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
7
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
4
Not reported
Not reported
Not reported
Not reported
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Progression (PD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
2
Not reported
Not reported
Not reported
Not reported
Dead
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Not Evaluable
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
7
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
2
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
3
Not reported
Not reported
Not reported
Not reported
Disease Status at Cycle 15 (Day 393 Assessment)
Stringent Complete Response (sCR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
18
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
9
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
9
Not reported
Not reported
Not reported
Not reported
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
17
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
5
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
13
Not reported
Not reported
Not reported
Not reported
Very Good Partial Remission (VGPR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
18
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
11
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
6
Not reported
Not reported
Not reported
Not reported
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
4
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
7
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
2
Not reported
Not reported
Not reported
Not reported
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Progression (PD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
3
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
1
Not reported
Not reported
Not reported
Not reported
Dead
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Not Evaluable
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
8
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
5
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
4
Not reported
Not reported
Not reported
Not reported
Disease Status at Cycle 18 (Day 477 Assessment)
Stringent Complete Response (sCR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
20
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
7
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
7
Not reported
Not reported
Not reported
Not reported
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
16
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
7
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
13
Not reported
Not reported
Not reported
Not reported
Very Good Partial Remission (VGPR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
17
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
14
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
6
Not reported
Not reported
Not reported
Not reported
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
3
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
6
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
1
Not reported
Not reported
Not reported
Not reported
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
2
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Progression (PD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
1
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
1
Not reported
Not reported
Not reported
Not reported
Dead
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Not Evaluable
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
9
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
3
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
7
Not reported
Not reported
Not reported
Not reported
Disease Status at Cycle 21 (Day 561 Assessment)
Stringent Complete Response (sCR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
20
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
6
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
10
Not reported
Not reported
Not reported
Not reported
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
15
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
5
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
11
Not reported
Not reported
Not reported
Not reported
Very Good Partial Remission (VGPR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
14
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
17
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
6
Not reported
Not reported
Not reported
Not reported
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
5
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
4
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
1
Not reported
Not reported
Not reported
Not reported
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Progression (PD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
2
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Dead
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
1
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Not Evaluable
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
11
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
5
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
7
Not reported
Not reported
Not reported
Not reported
Disease Status at Cycle 24 (Day 654 Assessment)
Stringent Complete Response (sCR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
19
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
6
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
9
Not reported
Not reported
Not reported
Not reported
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
15
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
7
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
11
Not reported
Not reported
Not reported
Not reported
Very Good Partial Remission (VGPR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
14
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
16
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
6
Not reported
Not reported
Not reported
Not reported
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
6
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
3
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
1
Not reported
Not reported
Not reported
Not reported
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Progression (PD)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
1
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
1
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
0
Not reported
Not reported
Not reported
Not reported
Dead
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
1
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
0
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
1
Not reported
Not reported
Not reported
Not reported
Not Evaluable
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Lenalidomide, Vaccine, and GM-CSF
12
Not reported
Not reported
Not reported
Not reported
Lenalidomide and GM-CSF
4
Not reported
Not reported
Not reported
Not reported
Maintenance Lenalidomide
7
Not reported
Not reported
Not reported
Not reported
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
group Description
The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 6 months Post Transplant.
group Ids
OG000
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.9376
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05
statistical Method
Chi-squared
group Description
In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 6 months Post Transplant.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.4887
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05
statistical Method
Chi-squared
group Description
In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 6 months Post Transplant.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.5176
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05
statistical Method
Chi-squared
group Description
In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between lenalidomide/GM-CSF arm and lenalidomide alone arm at 6 months Post Transplant.
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.2461
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05.
statistical Method
Chi-squared
group Description
The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 1 year Post Transplant.
group Ids
OG000
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.2530
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05
statistical Method
Chi-squared
group Description
In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 1 year Post Transplant.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.2213
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05.
statistical Method
Chi-squared
group Description
In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 1 year Post Transplant.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.4930
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05.
statistical Method
Chi-squared
group Description
In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the lenalidomide/GM-CSF arm and lenalidomide alone arm at 1 year Post Transplant.
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.6591
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05.
statistical Method
Chi-squared
group Description
The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 2 years Post Transplant.
group Ids
OG000
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.6790
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05
statistical Method
Chi-squared
group Description
In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 2 years Post Transplant.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.3124
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05.
statistical Method
Chi-squared
group Description
In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 2 years Post Transplant.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.7379
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05.
statistical Method
Chi-squared
group Description
In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the lenalidomide/GM-CSF arm and lenalidomide alone arm at 2 years Post Transplant.
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.2379
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05.
statistical Method
Chi-squared
Complete source fields
analyses
group Description
The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 6 months Post Transplant.
group Ids
OG000
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.9376
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05
statistical Method
Chi-squared
group Description
In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 6 months Post Transplant.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.4887
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05
statistical Method
Chi-squared
group Description
In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 6 months Post Transplant.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.5176
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05
statistical Method
Chi-squared
group Description
In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between lenalidomide/GM-CSF arm and lenalidomide alone arm at 6 months Post Transplant.
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.2461
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05.
statistical Method
Chi-squared
group Description
The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 1 year Post Transplant.
group Ids
OG000
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.2530
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05
statistical Method
Chi-squared
group Description
In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 1 year Post Transplant.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.2213
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05.
statistical Method
Chi-squared
group Description
In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 1 year Post Transplant.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.4930
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05.
statistical Method
Chi-squared
group Description
In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the lenalidomide/GM-CSF arm and lenalidomide alone arm at 1 year Post Transplant.
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.6591
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05.
statistical Method
Chi-squared
group Description
The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 2 years Post Transplant.
group Ids
OG000
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.6790
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05
statistical Method
Chi-squared
group Description
In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 2 years Post Transplant.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.3124
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05.
statistical Method
Chi-squared
group Description
In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 2 years Post Transplant.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.7379
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05.
statistical Method
Chi-squared
group Description
In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the lenalidomide/GM-CSF arm and lenalidomide alone arm at 2 years Post Transplant.
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.2379
p Value Comment
Statistical significance was determined using a pre-specified threshold of 0.05.
statistical Method
Chi-squared
classes
categories
measurements
group Id
OG000
value
12
group Id
OG001
value
9
group Id
OG002
value
8
title
Stringent Complete Response (sCR)
measurements
group Id
OG000
value
17
group Id
OG001
value
8
group Id
OG002
value
10
title
Complete Response (CR)
measurements
group Id
OG000
value
28
group Id
OG001
value
12
group Id
OG002
value
13
title
Very Good Partial Remission (VGPR)
measurements
group Id
OG000
value
5
group Id
OG001
value
5
group Id
OG002
value
2
title
Partial Response (PR)
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
0
title
Stable Disease (SD)
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Progression (PD)
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Dead
measurements
group Id
OG000
value
4
group Id
OG001
value
2
group Id
OG002
value
2
title
Not Evaluable
title
Disease Status at 6 Months
categories
measurements
group Id
OG000
value
18
group Id
OG001
value
8
group Id
OG002
value
9
title
Stringent Complete Response (sCR)
measurements
group Id
OG000
value
18
group Id
OG001
value
8
group Id
OG002
value
9
title
Complete Response (CR)
measurements
group Id
OG000
value
22
group Id
OG001
value
12
group Id
OG002
value
10
title
Very Good Partial Remission (VGPR)
measurements
group Id
OG000
value
4
group Id
OG001
value
7
group Id
OG002
value
3
title
Partial Response (PR)
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Stable Disease (SD)
measurements
group Id
OG000
value
5
group Id
OG001
value
0
group Id
OG002
value
2
title
Progression (PD)
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
title
Dead
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
2
title
Not Evaluable
title
Disease Status at 12 Months
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
7
group Id
OG002
value
9
title
Stringent Complete Response (sCR)
measurements
group Id
OG000
value
13
group Id
OG001
value
6
group Id
OG002
value
10
title
Complete Response (CR)
measurements
group Id
OG000
value
15
group Id
OG001
value
15
group Id
OG002
value
3
title
Very Good Partial Remission (VGPR)
measurements
group Id
OG000
value
6
group Id
OG001
value
4
group Id
OG002
value
2
title
Partial Response (PR)
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Stable Disease (SD)
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
0
title
Progression (PD)
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
1
title
Dead
measurements
group Id
OG000
value
13
group Id
OG001
value
5
group Id
OG002
value
10
title
Not Evaluable
title
Disease Status at 24 Months
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
9
group Id
OG002
value
7
title
Stringent Complete Response (sCR)
measurements
group Id
OG000
value
19
group Id
OG001
value
5
group Id
OG002
value
14
title
Complete Response (CR)
measurements
group Id
OG000
value
35
group Id
OG001
value
15
group Id
OG002
value
11
title
Very Good Partial Remission (VGPR)
measurements
group Id
OG000
value
5
group Id
OG001
value
6
group Id
OG002
value
2
title
Partial Response (PR)
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Stable Disease (SD)
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Progression (PD)
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Dead
measurements
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
1
title
Not Evaluable
title
Disease Status at Cycle 3 (Day 57 Assessment)
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
7
group Id
OG002
value
7
title
Stringent Complete Response (sCR)
measurements
group Id
OG000
value
18
group Id
OG001
value
7
group Id
OG002
value
14
title
Complete Response (CR)
measurements
group Id
OG000
value
28
group Id
OG001
value
14
group Id
OG002
value
10
title
Very Good Partial Remission (VGPR)
measurements
group Id
OG000
value
6
group Id
OG001
value
7
group Id
OG002
value
2
title
Partial Response (PR)
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
title
Stable Disease (SD)
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
title
Progression (PD)
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Dead
measurements
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
2
title
Not Evaluable
title
Disease Status at Cycle 6 (Day 141 Assessment)
categories
measurements
group Id
OG000
value
16
group Id
OG001
value
8
group Id
OG002
value
9
title
Stringent Complete Response (sCR)
measurements
group Id
OG000
value
17
group Id
OG001
value
7
group Id
OG002
value
15
title
Complete Response (CR)
measurements
group Id
OG000
value
24
group Id
OG001
value
13
group Id
OG002
value
7
title
Very Good Partial Remission (VGPR)
measurements
group Id
OG000
value
6
group Id
OG001
value
7
group Id
OG002
value
2
title
Partial Response (PR)
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Stable Disease (SD)
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
0
title
Progression (PD)
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Dead
measurements
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
2
title
Not Evaluable
title
Disease Status at Cycle 9 (Day 225 Assessment)
categories
measurements
group Id
OG000
value
18
group Id
OG001
value
9
group Id
OG002
value
9
title
Stringent Complete Response (sCR)
measurements
group Id
OG000
value
18
group Id
OG001
value
6
group Id
OG002
value
10
title
Complete Response (CR)
measurements
group Id
OG000
value
20
group Id
OG001
value
13
group Id
OG002
value
7
title
Very Good Partial Remission (VGPR)
measurements
group Id
OG000
value
5
group Id
OG001
value
7
group Id
OG002
value
4
title
Partial Response (PR)
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Stable Disease (SD)
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
2
title
Progression (PD)
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Dead
measurements
group Id
OG000
value
7
group Id
OG001
value
2
group Id
OG002
value
3
title
Not Evaluable
title
Disease Status at Cycle 12 (Day 309 Assessment)
categories
measurements
group Id
OG000
value
18
group Id
OG001
value
9
group Id
OG002
value
9
title
Stringent Complete Response (sCR)
measurements
group Id
OG000
value
17
group Id
OG001
value
5
group Id
OG002
value
13
title
Complete Response (CR)
measurements
group Id
OG000
value
18
group Id
OG001
value
11
group Id
OG002
value
6
title
Very Good Partial Remission (VGPR)
measurements
group Id
OG000
value
4
group Id
OG001
value
7
group Id
OG002
value
2
title
Partial Response (PR)
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Stable Disease (SD)
measurements
group Id
OG000
value
3
group Id
OG001
value
0
group Id
OG002
value
1
title
Progression (PD)
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Dead
measurements
group Id
OG000
value
8
group Id
OG001
value
5
group Id
OG002
value
4
title
Not Evaluable
title
Disease Status at Cycle 15 (Day 393 Assessment)
categories
measurements
group Id
OG000
value
20
group Id
OG001
value
7
group Id
OG002
value
7
title
Stringent Complete Response (sCR)
measurements
group Id
OG000
value
16
group Id
OG001
value
7
group Id
OG002
value
13
title
Complete Response (CR)
measurements
group Id
OG000
value
17
group Id
OG001
value
14
group Id
OG002
value
6
title
Very Good Partial Remission (VGPR)
measurements
group Id
OG000
value
3
group Id
OG001
value
6
group Id
OG002
value
1
title
Partial Response (PR)
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
0
title
Stable Disease (SD)
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
1
title
Progression (PD)
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Dead
measurements
group Id
OG000
value
9
group Id
OG001
value
3
group Id
OG002
value
7
title
Not Evaluable
title
Disease Status at Cycle 18 (Day 477 Assessment)
categories
measurements
group Id
OG000
value
20
group Id
OG001
value
6
group Id
OG002
value
10
title
Stringent Complete Response (sCR)
measurements
group Id
OG000
value
15
group Id
OG001
value
5
group Id
OG002
value
11
title
Complete Response (CR)
measurements
group Id
OG000
value
14
group Id
OG001
value
17
group Id
OG002
value
6
title
Very Good Partial Remission (VGPR)
measurements
group Id
OG000
value
5
group Id
OG001
value
4
group Id
OG002
value
1
title
Partial Response (PR)
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Stable Disease (SD)
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
0
title
Progression (PD)
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
title
Dead
measurements
group Id
OG000
value
11
group Id
OG001
value
5
group Id
OG002
value
7
title
Not Evaluable
title
Disease Status at Cycle 21 (Day 561 Assessment)
categories
measurements
group Id
OG000
value
19
group Id
OG001
value
6
group Id
OG002
value
9
title
Stringent Complete Response (sCR)
measurements
group Id
OG000
value
15
group Id
OG001
value
7
group Id
OG002
value
11
title
Complete Response (CR)
measurements
group Id
OG000
value
14
group Id
OG001
value
16
group Id
OG002
value
6
title
Very Good Partial Remission (VGPR)
measurements
group Id
OG000
value
6
group Id
OG001
value
3
group Id
OG002
value
1
title
Partial Response (PR)
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
Stable Disease (SD)
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
0
title
Progression (PD)
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
1
title
Dead
measurements
group Id
OG000
value
12
group Id
OG001
value
4
group Id
OG002
value
7
title
Not Evaluable
title
Disease Status at Cycle 24 (Day 654 Assessment)
denoms
counts
group Id
OG000
value
68
group Id
OG001
value
37
group Id
OG002
value
35
units
Participants
description
A participant's disease status is evaluated based on the International Uniform Response Criteria per protocol. Before disease progression (PD), all disease classifications including stringent complete response (sCR), complete response (CR), very good partial remission (VGPR), partial response (PR), stable disease (SD) are relative to participant's disease status at study entry. Disease status is 'Not Evaluable' when disease assessment is not required, or disease status is missing.
groups
description
Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will undergo leukapheresis and then will receive maintenance lenalidomide with myeloma vaccine and GM-CSF.
Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell will be isolated and frozen for subsequent vaccine generation.
Autologous Stem Cell Transplant: Patients will receive an autologous graft of a minimum cell dose of 2.0 x 10\^6 CD34+ cells/kg patient actual body weight per transplantation with high-dose melphalan of 200mg/m\^2 at the schedule and timing according to institutional practices.
Leukapheresis: Blood samples will be collected through a catheter in the neck or chest and leukapheresis will be performed using standard clinical procedures.
Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.
Myeloma vaccine: The target dose is 3 x 10\^6 fusion cells per vaccine. A minimum of 3 x 10\^6 total fusion cells will be required to proceed with vaccine administration. Patients will receive the DC/MM fusion vaccine on day 1 of cycles 2, 3, and 4 of lenalidomide maintenance.
GM-CSF: 100 ug GM-CSF will be given for a total of 4 days of each cycle.
id
OG000
title
Lenalidomide, Vaccine, and GM-CSF
description
Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide with GM-CSF.
Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery).
Autologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10\^6 CD34+ cells/kg patient actual body weight per autologous transplantation.
Melphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m\^2 at the schedule and timing according to institutional practices.
Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.
GM-CSF: 100 ug GM-CSF will be given subcutaneously in the upper thigh and daily for a total of 4 days of each cycle.
id
OG001
title
Lenalidomide and GM-CSF
description
Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide.
Tumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery).
Autologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10\^6 CD34+ cells/kg patient actual body weight per autologous transplantation.
Melphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m\^2 at the schedule and timing according to institutional practices.
Lenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.
id
OG002
title
Maintenance Lenalidomide
param Type
COUNT_OF_PARTICIPANTS
population Description
Analysis Population includes transplanted participants.
reporting Status
POSTED
time Frame
6 months, 1 year, and 2 years post-transplant and at Cycles 3(Day 57), 6(Day 141), 9(Day 225), 12(Day 309), 15 (Day 393), 18(Day 477), 21(Day 561) and 24(Day 654) of maintenance therapy
Triangle