A Phase 2 interventional study of Bortezomib and Lenalidomide in Multiple Myeloma, sponsored by Dana-Farber Cancer Institute. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-17.
Sponsored by Dana-Farber Cancer Institute · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the effectiveness and side effects of the bortezomib, lenalidomide and dexamethasone combination in relapsed or relapsed and refractory multiple myeloma. Each of these drugs are approved by the U.S Food and Drug Administration, but have not been approved in the combination for treating patients in this setting.
3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.
This study's enrollment of 65 is above the median of 41 across 2,965 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Dana-Farber Cancer Institute is the lead sponsor of 832 studies on the registry; 122 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants took the study medication in the clinic on Cycle 1 day 1. Each treatment cycle lasted three weeks. They took the lenalidomide (capsules) every day for the first two weeks only (days 1-14). They took the dexamethasone (tablets) on Day 1, 2, 4, 5, 8, 9, 11 and 12 and came to the outpatient treatment center for intravenous bortezomib on Day 1, 4, 8 and 11. The third week of the cycle was a rest period and the participant did not take any study medication.
Drug: Bortezomib · Drug: Lenalidomide · Drug: Dexamethasone
Given intravenously on days 1,4,8 and 11 of a 21-day cycle for a minimum of 8 cycles.
Taken orally once a day for 2 weeks (days 1-14) of a 21-day cycle for a minimum of 8 cycles
Taken orally on days 1,2,4,5,8,9,11,and 12 of a 21-day cycle for a minimum of 8 cycles
The Proportion of Patients Alive and Without Progressive Disease (PD) for ≥6 Months
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 frame: 6 months after therapy
Objective Response Rate
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 frame: Assessed every cycle for up to 8 cycles and best response was reported
Duration of 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.
Time frame: Assessed at a median follow-up of 44 months
Progression Free Survival
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 frame: aassesed at a median follow-up of 44 months
Overall Survival
defined as time from treatment initiation to death, or last known to be alive for those who had not died
Time frame: assesed at a median follow-up of 44 months
65 eligible participants were enrolled from the 6 institutions in the United States between September 2006 and April 2008 and 64 out of 65 received protocol treatment.
| Milestone | Lenalidomide, Dexamethasone, Bortezomib Combination |
|---|---|
| Started | 64 |
| Completed | 42 |
| Not completed | 22 |
| Withdrew: Progressive disease | 11 |
| Withdrew: Adverse event | 3 |
| Withdrew: Initiation of non-protocol therapy | 3 |
| Withdrew: Physician decision | 3 |
| Withdrew: Death | 1 |
| Withdrew: Treatment delay | 1 |
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).
| percentage of treated patients | Lenalidomide, Dexamethasone, Bortezomib Combination |
|---|---|
| The Proportion of Patients Alive and Without Progressive Disease (PD) for ≥6 Months | 75 (65 to 84) |
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).
| percentage of treated patients | Lenalidomide, Dexamethasone, Bortezomib Combination |
|---|---|
| Objective Response Rate | 64 (53 to 74) |
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.
| months | Lenalidomide, Dexamethasone, Bortezomib Combination |
|---|---|
| Duration of Response | 8.7 (6.6 to 11.1) |
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.
| months | Lenalidomide, Dexamethasone, Bortezomib Combination |
|---|---|
| Progression Free Survival | 9.5 (7.2 to 11.7) |
defined as time from treatment initiation to death, or last known to be alive for those who had not died
| month | Lenalidomide, Dexamethasone, Bortezomib Combination |
|---|---|
| Overall Survival | 30 (24 to 37) |
Collected over 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. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lenalidomide, Dexamethasone, Bortezomib Combination | — | 47/64 (73.4%) | 34/64 (53.1%) |
| Event | Lenalidomide, Dexamethasone, Bortezomib Combination |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 19/64 |
| ThrombocytopeniaBlood and lymphatic system disorders | 14/64 |
| LymphopeniaBlood and lymphatic system disorders | 7/64 |
| hyperglycemiaMetabolism and nutrition disorders | 6/64 |
| LeukopeniaBlood and lymphatic system disorders | 6/64 |
| HypophosphatemiaMetabolism and nutrition disorders | 6/64 |
| HyponatremiaMetabolism and nutrition disorders | 5/64 |
| Pulmonary/ Upper Respiratory EventRespiratory, thoracic and mediastinal disorders | 4/64 |
| FatigueGeneral disorders | 3/64 |
| DiarrheaGastrointestinal disorders | 2/64 |
| Event | Lenalidomide, Dexamethasone, Bortezomib Combination |
|---|---|
| Sensory NeuropathyNervous system disorders | 34/64 |
| FatigueGeneral disorders | 29/64 |
| Muscle PainMusculoskeletal and connective tissue disorders | 25/64 |
| DiarrheaGastrointestinal disorders | 24/64 |
| Peripheral EdemaBlood and lymphatic system disorders | 20/64 |
| ConstipationGastrointestinal disorders | 19/64 |
| HyperglycemiaMetabolism and nutrition disorders | 18/64 |
| InsomniaGeneral disorders | 18/64 |
| NauseaGastrointestinal disorders | 15/64 |
| InfectionInfections and infestations | 15/64 |
65 patients were enrolled and 64 were treated. One patient who was never treated was excluded from the analysis.
| Age, Continuous(years) | Lenalidomide, Dexamethasone, Bortezomib Combination |
|---|---|
| Median | 65 (32 to 83) |
| Sex: Female, Male(Participants) | Lenalidomide, Dexamethasone, Bortezomib Combination |
|---|---|
| Female | 22 |
| Male | 42 |
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Bortezomib · Lenalidomide · Dexamethasone
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