Status:
COMPLETED
Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
* 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 1-1...
Eligibility Criteria
Inclusion
- Diagnosis of multiple myeloma based on standard diagnostic criteria or by the new International Myeloma Foundation 2003 Diagnostic Criteria
- Relapsed or relapsed and refractory disease after receiving between 1 and 3 prior regimens
- Negative serum or urine pregnancy test
- Age 18 years or older
- Karnofsky performance status of 60 or greater
Exclusion
- Grade 2 or greater peripheral neuropathy within 14 days before enrollment
- Renal insufficiency (serum creatinine \> 2.5 mg/dL)
- Evidence of mucosal or internal bleeding and/or platelet refractory
- ANC \< 1000 cells/mm3
- Hemoglobin \< 8.0 g/dL
- AST or ALT greater than or equal to 2 x ULN
- Concomitant therapy medications that include corticosteroids
- Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Clinically relevant active infection or serious co-morbid medical conditions
- Prior malignancy (within last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or breast cancer, in situ prostate cancer
- Pregnant or breast-feeding
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Uncontrolled diabetes mellitus
- Hypersensitivity to acyclovir or similar anti-viral drug
- POEMS syndrome
- Known HIV infection
- Known active hepatitis B or C viral infection
- Known intolerance to steroid therapy
- Subjects with primary refractory disease, defined as progression during initial treatment
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00378209
Start Date
August 1 2006
End Date
October 1 2016
Last Update
November 17 2016
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115