Melphalan and Radiation Therapy Followed By Lenalidomide in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant for Stage I, Stage II, or Stage III Multiple Myelom

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The highest dose tested (Total Marrow Irradiation) in which there is no treatment related mortality and none or only one patient experienced dose limited toxicity (DLT) attributable to the study drug(s), when at least six were fully treated at that dose and fully followed for toxicity. The MTD is one dose level below the lowest dose tested in which 2 or more patients experienced DLT attributable to the treatment or there was a treatment related death. At least 6 patients will be treated at the MTD.

All patients enrolled in the dose-finding portion of the study.

→

primary · POSTED

Response defined as complete response or very good partial response. Complete response defined as the absence of bone marrow or blood findings of multiple myeloma on at least 2 measurements at a minimum of a 6 week interval. Thus all evidence of serum and urinary M-components must disappear on electrophoresis as well as by immunofixation studies. The follow-up bone marrow may not contain more than 5% plasma cells on aspiration or core biopsy and no evidence of increasing anemia. Skeletal X-rays must either show recalcification or no change in osteolytic lesions. Resolution of soft tissue plasmocytomas. Very good partial response defined as reduction of bone marrow or blood findings of multiple myeloma on at least 2 measurements at a minimum of a 6 week interval by greater than or equal to 90%.

Source null

→

primary · POSTED

Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause.

Overall survival was calculated for aggregated arms, due to small number of patients in most treatment arms.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-multiple-myeloma-darzalex-faspro-f9050675
nct id: NCT00112827
trial label: Melphalan and Radiation Therapy Followed By Lenalidomide in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant for Stage I, Stage II, or Stage III Multiple Myelom
applicability: unclear
applicability note: Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 3
harms Count: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00112827
outcome key
om-0000
source section id
NCT00112827-om-0000
source outcome index
0
endpoint
Maximum Tolerated Dose (MTD)
endpoint definition
The highest dose tested (Total Marrow Irradiation) in which there is no treatment related mortality and none or only one patient experienced dose limited toxicity (DLT) attributable to the study drug(s), when at least six were fully treated at that dose and fully followed for toxicity. The MTD is one dose level below the lowest dose tested in which 2 or more patients experienced DLT attributable to the treatment or there was a treatment related death. At least 6 patients will be treated at the MTD.
time origin
8 weeks from start of treatment, up to 2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All patients enrolled in the dose-finding portion of the study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00112827
outcome key
om-0001
source section id
NCT00112827-om-0001
source outcome index
1
endpoint
Number of Subjects With Response
endpoint definition
Response defined as complete response or very good partial response. Complete response defined as the absence of bone marrow or blood findings of multiple myeloma on at least 2 measurements at a minimum of a 6 week interval. Thus all evidence of serum and urinary M-components must disappear on electrophoresis as well as by immunofixation studies. The follow-up bone marrow may not contain more than 5% plasma cells on aspiration or core biopsy and no evidence of increasing anemia. Skeletal X-rays must either show recalcification or no change in osteolytic lesions. Resolution of soft tissue plasmocytomas. Very good partial response defined as reduction of bone marrow or blood findings of multiple myeloma on at least 2 measurements at a minimum of a 6 week interval by greater than or equal to 90%.
time origin
Evaluated after each course until completion of treatment.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00112827
outcome key
om-0002
source section id
NCT00112827-om-0002
source outcome index
2
endpoint
Overall Survival
endpoint definition
Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause.
time origin
From date of treatment until the date of death from any cause, assessed up to 14 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Overall survival was calculated for aggregated arms, due to small number of patients in most treatment arms.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00112827
outcome key
om-0000
arm key
OG000
arm label
Treatment Arm
regimen
See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112827-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00112827
outcome key
om-0001
arm key
OG000
arm label
Phase 1 Cohort 1 (Total TMI Dose: 1000 cGy)
regimen
See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112827-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00112827
outcome key
om-0001
arm key
OG001
arm label
Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy)
regimen
See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112827-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00112827
outcome key
om-0001
arm key
OG002
arm label
Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy)
regimen
See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112827-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00112827
outcome key
om-0001
arm key
OG003
arm label
Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy)
regimen
See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112827-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00112827
outcome key
om-0001
arm key
OG004
arm label
Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy)
regimen
See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112827-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00112827
outcome key
om-0002
arm key
OG000
arm label
Treatment Arm
regimen
See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally
analyzed count
54
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00112827-om-0002#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00112827
harm key
EG000
source section id
NCT00112827-ae
event group key
EG000
event group label
Phase 1 Cohort 1 (Total TMI Dose: 1000 cGy)
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Adverse events occurred over a period of 14 years and 3 months.
event definition
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00112827
harm key
EG001
source section id
NCT00112827-ae
event group key
EG001
event group label
Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy)
serious affected
0
serious at risk
4
other affected
4
other at risk
4
frequency threshold
0
collection period
Adverse events occurred over a period of 14 years and 3 months.
event definition
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00112827
harm key
EG002
source section id
NCT00112827-ae
event group key
EG002
event group label
Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy)
serious affected
0
serious at risk
4
other affected
3
other at risk
4
frequency threshold
0
collection period
Adverse events occurred over a period of 14 years and 3 months.
event definition
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00112827
harm key
EG003
source section id
NCT00112827-ae
event group key
EG003
event group label
Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy)
serious affected
6
serious at risk
36
other affected
33
other at risk
36
frequency threshold
0
collection period
Adverse events occurred over a period of 14 years and 3 months.
event definition
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00112827
harm key
EG004
source section id
NCT00112827-ae
event group key
EG004
event group label
Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy)
serious affected
3
serious at risk
7
other affected
7
other at risk
7
frequency threshold
0
collection period
Adverse events occurred over a period of 14 years and 3 months.
event definition
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice