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