TriangleNCT00112827 · STUDY IN CONTEXT
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
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.
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%.
Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause.
Reported safety
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-sarclisa-escena-9eb42ed1
- 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-sarclisa-escena-9eb42ed1
- 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-sarclisa-escena-9eb42ed1
- 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-sarclisa-escena-9eb42ed1
- 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-sarclisa-escena-9eb42ed1
- 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-sarclisa-escena-9eb42ed1
- 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-sarclisa-escena-9eb42ed1
- 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-sarclisa-escena-9eb42ed1
- 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-sarclisa-escena-9eb42ed1
- 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-sarclisa-escena-9eb42ed1
- 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-sarclisa-escena-9eb42ed1
- 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-sarclisa-escena-9eb42ed1
- 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-sarclisa-escena-9eb42ed1
- 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-sarclisa-escena-9eb42ed1
- 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-sarclisa-escena-9eb42ed1
- 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-sarclisa-escena-9eb42ed1
- 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