Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Bortezomib; Lenalidomide; Dexamethasone
Intervention description: 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
Intervention MeSH terms: Dexamethasone; Lenalidomide; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: relapsed multiple myeloma; refractory multiple myeloma

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.
    

Eligibility 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