Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Celgene Corporation; Massachusetts General Hospital; Millennium Pharmaceuticals, Inc.
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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