Bortezomib, Lenalidomide and Dexamethasone Combination Therapy in Patients With Newly Diagnosed Multiple Myeloma
NCT00378105 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2026-02-24
Summary
The purpose of this study is to determine the safety and efficacy of the bortezomib, lenalidomide and dexamethasone combination in patients with newly diagnosed multiple myeloma. We are looking for the highest dose of the combination that can be given safely and see how well it works as a combination in newly diagnosed patients.
Conditions
Interventions
- DRUG
-
Intravenously on days 1, 4, 8 and 11 of a 21 day cycle for a minimum of 8 cycles (dosage will vary depending upon when the participant enters the trial)
- DRUG
-
Taken orally twice a day for 2 weeks (days 1-14) of each 21-day cycle for a minimum of 8 cycles (dosage will vary depending upon when participant enters trial).
- DRUG
-
Taken orally on days 1,2,4,5,8,9,11 of a 21-day cycle for a minimum of 8 cycles.
Sponsors & Collaborators
-
Brigham and Women's Hospital
collaborator OTHER -
Beth Israel Deaconess Medical Center
collaborator OTHER -
Massachusetts General Hospital
collaborator OTHER -
Celgene Corporation
collaborator INDUSTRY -
Millennium Pharmaceuticals, Inc.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Paul Richardson, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-09-30
- Primary Completion
- 2009-07-31
- Completion
- 2026-12-31
Countries
- United States
Study Locations
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