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

- Participants took the study medication in the clinic on Cycle 1 day 1. Each treatment
cycle lasted three weeks. They took the lenalidomide (capsules) every day for the first
two weeks only (days 1-14). They took dexamethasone (tablets) on Day 1, 2, 4, 5, 8, 9,
11 and 12 and came to the outpatient treatment center for intravenous bortezomib on Day
1, 4, 8 and 11. The third week of the cycle was a rest period and the participant did
not take any study medication.

- Certain tests and procedures were performed throughout each treatment cycle at
definitive time periods. These tests included: medical history update,
physical/neurological examination, skeletal survey (x-rays or scan), blood samples,
urine samples, optional bone marrow aspiration/tissue biopsy, 12-lead ECG, and MRI/CT
(if needed).

- It was expected that participants were going to complete at least 8 cycles of the
study, which adds up to 168 days. If the participant completed the first 8 cycles, had
stable or responding disease and had not experienced bad side effects, they were
allowed to continue treatment on a maintenance schedule, detailed in the protocol, at
the study doctor's discretion.

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