A Phase 2 interventional study of bortezomib, dexamethasone, and thalidomide and bortezomib, dexamethasone, thalidomide, and cyclophosphamide in Multiple Myeloma, sponsored by Millennium Pharmaceuticals, Inc.. Completed at 1 site in Austria. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-01-26.
Sponsored by Millennium Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
The purpose of this Phase 2 randomized study is to evaluate the efficacy and safety of treatment with a regimen of VELCADE, dexamethasone, and thalidomide (VDT) or VELCADE, dexamethasone, thalidomide, and cyclophosphamide (VDTC) in subjects with newly diagnosed symptomatic multiple myeloma who have received no prior treatment and are candidates to receive high-dose therapy and autologous bone marrow/stem cell transplantation.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 98 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Millennium Pharmaceuticals, Inc. is the lead sponsor of 173 studies on the registry; none are open to participants now.
Of its 73 completed or terminated interventional studies of FDA-regulated products, 72 (99%) have results posted.
Counted across the registry records on this site, refreshed daily.
PLUS 1 or more of the following:
AND fulfill criteria for measurable disease, as defined by at least 1 of the following 3 measurements:
Exclusion Criteria:
bortezomib, dexamethasone, and thalidomide
Drug: bortezomib, dexamethasone, and thalidomide
bortezomib, dexamethasone, thalidomide, and cyclophosphamide
Drug: bortezomib, dexamethasone, thalidomide, and cyclophosphamide
VELCADE (bortezomib) twice weekly for 4 cycles (4 doses per cycle), prior to high-dose chemotherapy (HDT) and stem cell transplantation(SCT). Subjects will receive VELCADE 1.3 mg/m2 as an intravenous (i.v.) bolus injection on Days 1,4,8, and 11, followed by a 10 day rest period (Days 12 to 21) Dexamethasone 40 mg/day will be given by mouth (p.o.) on Days 1-4 and Days 9-12 in each of 4 cycles. Thalidomide will be given by mouth (p.o.)every day, starting on Day 1 of Cycle 1 (e.g. the same day of the first dose of VELCADE) and continuing until Day 21 of Cycle 4 at a dose of 100 mg/day (bedtime).
VELCADE (bortezomib) twice weekly for 4 cycles (4 doses per cycle), prior to high-dose chemotherapy(HDT)and stem cell transplantation(SCT). Subjects will receive VELCADE 1.3 mg/m2 as an intravenous (i.v.) bolus injection on Days 1,4,8, and 11, followed by a 10 day rest period (Days 12 to 21). Dexamethasone 40 mg/day will be given by mouth (p.o.) on Days 1-4 and Days 9-12 in each of 4 cycles. Thalidomide will be given by mouth (p.o.) every day, starting on Day 1 of Cycle 1 (e.g., the same day of the first dose of VELCADE) and continuing until Day 21 of Cycle 4 at a dose of 100 mg/day (bedtime). Cyclophosphamide will be given as an intravenous (i.v.) dose of 400 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for a total of 4 cycles.
Percent of Particpants Achieving Overall Combined Complete Response (CR) Following Induction
Percent of Particpants Achieving Overall combined complete response (CR w/normalized serum κ:λ ratio + CR + near complete response (nCR)) following induction therapy. * CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. * κ:λ ratio: normal free light chain (FLC) ratio * nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow.
Time frame: all data included in clinical database as of 10 April 2009
Percent of Participants Achieving Overall Combined Complete Response (CR) Following High-dose Chemotherapy (HDT)/Stem Cell Transplantation (SCT)
Percent of Participants Achieving Overall Combined Complete Response (CR) (CR w/normalized serum κ:λ ratio + CR + Near Complete Response (nCR)) following stem cell transplantation. * CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. * κ:λ ratio: normal free light chain (FLC) ratio * nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow.
Time frame: all data included in clinical database as of 10 April 2009
98 patients were enrolled between October 2007 and September 2008
| Milestone | Three Drug Regimen (VDT) | Four Drug Regimen (VDTC) |
|---|---|---|
| Started | 49 | 49 |
| Completed | 49 | 49 |
| Not completed | 0 | 0 |
Percent of Particpants Achieving Overall combined complete response (CR w/normalized serum κ:λ ratio + CR + near complete response (nCR)) following induction therapy. * CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. * κ:λ ratio: normal free light chain (FLC) ratio * nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow.
| percentage of participants | Three Drug Regimen (VDT) | Four Drug Regimen (VDTC) |
|---|---|---|
| Percent of Particpants Achieving Overall Combined Complete Response (CR) Following Induction | 51 | 44 |
Percent of Participants Achieving Overall Combined Complete Response (CR) (CR w/normalized serum κ:λ ratio + CR + Near Complete Response (nCR)) following stem cell transplantation. * CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. * κ:λ ratio: normal free light chain (FLC) ratio * nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow.
| percentage of participants | Three Drug Regimen (VDT) | Four Drug Regimen (VDTC) |
|---|---|---|
| Percent of Participants Achieving Overall Combined Complete Response (CR) Following High-dose Chemotherapy (HDT)/Stem Cell Transplantation (SCT) | 76 (NE to NE) | 78 (NE to NE) |
Collected over From first dose to 30 days post last dose. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Three Drug Regimen (VDT) | — | 11/49 (22.4%) | 48/49 (98%) |
| Four Drug Regimen (VDTC) | — | 20/49 (40.8%) | 47/49 (95.9%) |
| Event | Three Drug Regimen (VDT) | Four Drug Regimen (VDTC) |
|---|---|---|
| Infections and InfestationsInfections and infestations | 3/49 | 7/49 |
| Musculoskeletal and Connective Tissue DisordersMusculoskeletal and connective tissue disorders | 1/49 | 7/49 |
| Gastrointestinal DisordersGastrointestinal disorders | 4/49 | 4/49 |
| General Disorders and administration site ConditionsGeneral disorders | 4/49 | 4/49 |
| Respiratory, Thoracic and mediastinal DisordersRespiratory, thoracic and mediastinal disorders | 3/49 | 4/49 |
| Nervous System DisordersNervous system disorders | 3/49 | 2/49 |
| Blood and Lymphatic System DisordersBlood and lymphatic system disorders | 1/49 | 2/49 |
| Cardiac DisordersCardiac disorders | 1/49 | 2/49 |
| Injury, Poisoning and Procedural ComplicationsInjury, poisoning and procedural complications | 0/49 | 2/49 |
| Metabolism and Nutritional DisordersMetabolism and nutrition disorders | 1/49 | 1/49 |
| Event | Three Drug Regimen (VDT) | Four Drug Regimen (VDTC) |
|---|---|---|
| Gastrointestinal DisordersGastrointestinal disorders | 30/49 | 32/49 |
| Nervous System DisordersNervous system disorders | 31/49 | 27/49 |
| General Disorders and Administration Site ConditionsGeneral disorders | 28/49 | 28/49 |
| Blood and Lymphatic System DisordersBlood and lymphatic system disorders | 15/49 | 22/49 |
| Skin and Subcutaneous Tissue DisordersSkin and subcutaneous tissue disorders | 18/49 | 12/49 |
| Musculoskeletal and Connective Tissue DisordersMusculoskeletal and connective tissue disorders | 17/49 | 13/49 |
| Metabolism and Nutrition DisordersMetabolism and nutrition disorders | 16/49 | 15/49 |
| Infections and InfestationsInfections and infestations | 15/49 | 11/49 |
| Vascular DisordersVascular disorders | 8/49 | 13/49 |
| Respiratory, Thoracic and Mediastinal DisordersRespiratory, thoracic and mediastinal disorders | 9/49 | 9/49 |
| Age, Categorical(Participants) | Three Drug Regimen (VDT) | Four Drug Regimen (VDTC) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 46 | 44 | 90 |
| >=65 years | 3 | 5 | 8 |
| Age Continuous(years) | Three Drug Regimen (VDT) | Four Drug Regimen (VDTC) | Total |
|---|---|---|---|
| Mean | 55.1 ± 7.04 | 55.8 ± 8.27 | 55.4 ± 7.65 |
| Sex: Female, Male(Participants) | Three Drug Regimen (VDT) | Four Drug Regimen (VDTC) | Total |
|---|---|---|---|
| Female | 26 | 25 | 51 |
| Male | 23 | 24 | 47 |
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Millennium Pharmaceuticals, Inc.