TriangleNCT00378209 · STUDY IN CONTEXT
Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma
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
Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG). Progressive disease (PD) required one or more of the following: \>25% increased in serum monoclonal paraprotein (must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation) \>25% increased in 24-hour urinary light chain excretion (must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation) \>25% increased in plasma cells in a bone marrow aspirate or on trephine biopsy (must also be an absolute increase of at least 10%) Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture). Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).
Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG). Objective response was defined by the achievement of at least Partial Response (PR) or better (CR-complete response, nCR-near complete response, and VGPR-very good partial response).
Duration of response will be measured as the time from initiation of a response to first documentation of disease progression or death, or date last known progression-free and alive for those who have not progressed or died.
Progression-free survival is defined as the time from registration to the disease progression or death from any cause, censored at date last known progression-free for those who have not progressed or died.
defined as time from treatment initiation to death, or last known to be alive for those who had not died
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-darzalex-faspro-f9050675
- nct id
- NCT00378209
- trial label
- Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma
- 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
- 5
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-darzalex-faspro-f9050675
- nct id
- NCT00378209
- outcome key
- om-0000
- source section id
- NCT00378209-om-0000
- source outcome index
- 0
- endpoint
- The Proportion of Patients Alive and Without Progressive Disease (PD) for ≥6 Months
- endpoint definition
- Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG). Progressive disease (PD) required one or more of the following: \>25% increased in serum monoclonal paraprotein (must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation) \>25% increased in 24-hour urinary light chain excretion (must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation) \>25% increased in plasma cells in a bone marrow aspirate or on trephine biopsy (must also be an absolute increase of at least 10%) Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture). Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).
- time origin
- 6 months after therapy
- 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
- NCT00378209
- outcome key
- om-0001
- source section id
- NCT00378209-om-0001
- source outcome index
- 1
- endpoint
- Objective Response Rate
- endpoint definition
- Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG). Objective response was defined by the achievement of at least Partial Response (PR) or better (CR-complete response, nCR-near complete response, and VGPR-very good partial response).
- time origin
- Assessed every cycle for up to 8 cycles and best response was reported
- analysis role
- secondary
- 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
- NCT00378209
- outcome key
- om-0002
- source section id
- NCT00378209-om-0002
- source outcome index
- 2
- endpoint
- Duration of Response
- endpoint definition
- Duration of response will be measured as the time from initiation of a response to first documentation of disease progression or death, or date last known progression-free and alive for those who have not progressed or died.
- time origin
- Assessed at a median follow-up of 44 months
- analysis role
- secondary
- 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
- NCT00378209
- outcome key
- om-0003
- source section id
- NCT00378209-om-0003
- source outcome index
- 3
- endpoint
- Progression Free Survival
- endpoint definition
- Progression-free survival is defined as the time from registration to the disease progression or death from any cause, censored at date last known progression-free for those who have not progressed or died.
- time origin
- aassesed at a median follow-up of 44 months
- analysis role
- secondary
- 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
- NCT00378209
- outcome key
- om-0004
- source section id
- NCT00378209-om-0004
- source outcome index
- 4
- endpoint
- Overall Survival
- endpoint definition
- defined as time from treatment initiation to death, or last known to be alive for those who had not died
- time origin
- assesed at a median follow-up of 44 months
- analysis role
- secondary
- 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-darzalex-faspro-f9050675
- nct id
- NCT00378209
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Lenalidomide, Dexamethasone, Bortezomib Combination
- regimen
- Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8. Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00378209-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-darzalex-faspro-f9050675
- nct id
- NCT00378209
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Lenalidomide, Dexamethasone, Bortezomib Combination
- regimen
- Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8. Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00378209-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-darzalex-faspro-f9050675
- nct id
- NCT00378209
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Lenalidomide, Dexamethasone, Bortezomib Combination
- regimen
- Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8. Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00378209-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-darzalex-faspro-f9050675
- nct id
- NCT00378209
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Lenalidomide, Dexamethasone, Bortezomib Combination
- regimen
- Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8. Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00378209-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-darzalex-faspro-f9050675
- nct id
- NCT00378209
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Lenalidomide, Dexamethasone, Bortezomib Combination
- regimen
- Lenalidomide, Dexamethasone, Bortezomib Combination
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00378209-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-darzalex-faspro-f9050675
- nct id
- NCT00378209
- harm key
- EG000
- source section id
- NCT00378209-ae
- event group key
- EG000
- event group label
- Lenalidomide, Dexamethasone, Bortezomib Combination
- serious affected
- 47
- serious at risk
- 64
- other affected
- 34
- other at risk
- 64
- frequency threshold
- 5
- collection period
- Assessed every cycle while on treatment (including both 8 cycles of combination therapy and maintenance therapy) and for 30 days after the end of treatment
- event definition
- Source null
- 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