An Open-Label Phase I/II Study of the Safety and Efficacy of Bortezomib, Lenalidomide and Dexamethasone Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma

Inclusion Criteria:

- Diagnosed with multiple myeloma based on standard diagnostic criteria or by the new
International Myeloma Foundation 2003 Diagnostic Criteria

- Must not have been previously treated with any prior systemic therapy for the
treatment of multiple myeloma

- Negative serum or urine pregnancy test

- Age 18 years or older

- Karnofsky performance status of greater or equal to 60

Exclusion Criteria:

- Greater or equal to Grade 2 peripheral neuropathy on clinical examination 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 according to NYHY 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 except adequately treated basal cell or squamous cell skin cancer,
in situ cervical, breast or prostate cancer

- Pregnant or breast-feeding

- Serious medical or psychiatric illness likely to interfere with participation in
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