At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of multiple myeloma by standard diagnostic criteria or IMF 2003 Diagnostic Criteria
- ✓Relapsed or relapsed and refractory disease after 1-3 prior regimens
- ✓Age 18 years or older
- ✓Karnofsky performance status ≥60
- ✕Grade 2 or greater peripheral neuropathy within 14 days before enrollment
- ✕Renal insufficiency with serum creatinine >2.5 mg/dL
- ✕Evidence of mucosal or internal bleeding and/or platelet refractory
- ✕Myocardial infarction within 6 months prior to enrollment or NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Am Open-Label Phase II Study of the Safety and Efficacy of Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma
In Brief
A Phase 2 clinical trial evaluating Bortezomib, Lenalidomide, and 1 other intervention for Multiple Myeloma. Completed, enrolled 65 participants across 2 sites.
Detailed 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 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.
Study Details
Timeline
Interventions
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