NCT02440464 · OUTCOME
Percentage of Participants With Response to Treatment
Allogeneic Hematopoietic Stem Cell Transplantation With Ixazomib for High Risk Multiple Myeloma (BMT CTN 1302) · Source last updated 2023-01-04
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
- 18 months and 24 months post-transplant
What was measured
Response was assessed using the International Uniform Response Criteria. All disease classifications are relative to the patient's disease status prior to allogeneic transplant (i.e. study entry). Response to treatment after randomization (sCR, CR, VGPR, or PR) is summarized in each arm post-transplant at 18 months and 24 months post-transplant. These response data were summarized separately for patients in sCR/CR at the time of randomization vs. those who were not in sCR/CR at the time of randomization.
Analysis population: All randomized participants were included in the analysis. Participants were divided into those in sCR/CR at the time of randomization vs. those who were not in sCR/CR at the time of randomization. Reasons participants were not evaluable were either they withdrew from study or missed an assessment.
Groups in this outcome
Ixazomib Maintenance
Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by Ixazomib maintenance
Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.
Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.
Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.
Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.
Ixazomib: Between 60 and 120 days following HSCT, patients randomized to the experimental arm will receive Ixazomib maintenance. Maintenance will begin at 3-mg oral doses on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule, following successful completion of 3 cycles at the previous dosage, for a total of 12 cycles.
Placebo
Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by placebo maintenance.
Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.
Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.
Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.
Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.
Placebo: Between 60 and 120 days following HSCT, patients randomized to the control group will be given 3 mg of placebo orally on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule following successful completion of 3 cycles of placebo maintenance at the 3-mg dose. This will continue for a total of 12 cycles.
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 |
|---|
| Ixazomib Maintenance | 21 |
|---|
| Placebo | 22 |
|---|
Reported measurements
Response to Treatment at 18 Months Post-transplant for Participants in sCR/CR at Randomization
Analysis denominator · Participants
| Group | Source count |
|---|
| Ixazomib Maintenance | 9 |
|---|
| Placebo | 11 |
|---|
Stringent Complete Response (sCR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good Partial Response (VGPR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease (PD)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Died Before Evaluation
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Response to Treatment at 18 Months Post-transplant for Participants Not in sCR/CR at Randomization
Analysis denominator · Participants
| Group | Source count |
|---|
| Ixazomib Maintenance | 12 |
|---|
| Placebo | 11 |
|---|
Stringent Complete Response (sCR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good Partial Response (VGPR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease (PD)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Died Before Evaluation
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Response to Treatment at 24 Months Post-transplant for Participants in sCR/CR at Randomization
Analysis denominator · Participants
| Group | Source count |
|---|
| Ixazomib Maintenance | 9 |
|---|
| Placebo | 11 |
|---|
Stringent Complete Response (sCR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good Partial Response (VGPR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease (PD)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Died Before Evaluation
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Response to Treatment at 24 Months Post-transplant for Participants Not in sCR/CR at Randomization
Analysis denominator · Participants
| Group | Source count |
|---|
| Ixazomib Maintenance | 12 |
|---|
| Placebo | 11 |
|---|
Stringent Complete Response (sCR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good Partial Response (VGPR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease (PD)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Died Before Evaluation
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ixazomib Maintenance | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- title
- Stringent Complete Response (sCR)
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- title
- Complete Response (CR)
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- Very Good Partial Response (VGPR)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Partial Response (PR)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Stable Disease (SD)
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- title
- Progressive Disease (PD)
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- Died Before Evaluation
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Not Evaluable
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 11
- units
- Participants
- title
- Response to Treatment at 18 Months Post-transplant for Participants in sCR/CR at Randomization
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- title
- Stringent Complete Response (sCR)
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- Complete Response (CR)
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- title
- Very Good Partial Response (VGPR)
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Partial Response (PR)
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Stable Disease (SD)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Progressive Disease (PD)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Died Before Evaluation
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- title
- Not Evaluable
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 11
- units
- Participants
- title
- Response to Treatment at 18 Months Post-transplant for Participants Not in sCR/CR at Randomization
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Stringent Complete Response (sCR)
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- title
- Complete Response (CR)
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Very Good Partial Response (VGPR)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Partial Response (PR)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Stable Disease (SD)
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- title
- Progressive Disease (PD)
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- Died Before Evaluation
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- title
- Not Evaluable
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 11
- units
- Participants
- title
- Response to Treatment at 24 Months Post-transplant for Participants in sCR/CR at Randomization
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- title
- Stringent Complete Response (sCR)
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- Complete Response (CR)
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- title
- Very Good Partial Response (VGPR)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Partial Response (PR)
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Stable Disease (SD)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Progressive Disease (PD)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Died Before Evaluation
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 2
- title
- Not Evaluable
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 11
- units
- Participants
- title
- Response to Treatment at 24 Months Post-transplant for Participants Not in sCR/CR at Randomization
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 22
- units
- Participants
- description
- Response was assessed using the International Uniform Response Criteria. All disease classifications are relative to the patient's disease status prior to allogeneic transplant (i.e. study entry). Response to treatment after randomization (sCR, CR, VGPR, or PR) is summarized in each arm post-transplant at 18 months and 24 months post-transplant. These response data were summarized separately for patients in sCR/CR at the time of randomization vs. those who were not in sCR/CR at the time of randomization.
- groups
- description
- Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by Ixazomib maintenance
Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.
Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.
Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.
Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.
Ixazomib: Between 60 and 120 days following HSCT, patients randomized to the experimental arm will receive Ixazomib maintenance. Maintenance will begin at 3-mg oral doses on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule, following successful completion of 3 cycles at the previous dosage, for a total of 12 cycles.
- id
- OG000
- title
- Ixazomib Maintenance
- description
- Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by placebo maintenance.
Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.
Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.
Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.
Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.
Placebo: Between 60 and 120 days following HSCT, patients randomized to the control group will be given 3 mg of placebo orally on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule following successful completion of 3 cycles of placebo maintenance at the 3-mg dose. This will continue for a total of 12 cycles.
- id
- OG001
- title
- Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All randomized participants were included in the analysis. Participants were divided into those in sCR/CR at the time of randomization vs. those who were not in sCR/CR at the time of randomization. Reasons participants were not evaluable were either they withdrew from study or missed an assessment.
- reporting Status
- POSTED
- time Frame
- 18 months and 24 months post-transplant
- title
- Percentage of Participants With Response to Treatment
- type
- SECONDARY
- unit Of Measure
- Participants
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