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

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