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

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