Thalidomide + Dexamethasone vs. DOXIL (Doxorubicin HCl Liposome Injection) + Thalidomide + Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

• Complete Response Rate Defined as the Number of Participants Who Achieve a Complete Response [ Time Frame: Cycle 2 until 28 days following completion of treatment ] [ Designated as safety issue: No ]
  This is assessed at the beginning of every treatment cycle prior to treatment starting at Cycle 2. Complete response must be maintained for at least 6 weeks.
  
  

• Overall Response [ Time Frame: Cycle 2 until 28 days following completion of treatment ] [ Designated as safety issue: No ]
  Overall response rate defined as the number of participants who achieve a complete response (CR) or partial response (PR).
  
  
• Time to 1st Response [ Time Frame: Cycle 2 until 28 days following completion of treatment ] [ Designated as safety issue: No ]
  Time to 1st response defined as the number of days to achieve a complete response (CR) or partial response (PR).
  
  
• Time to Progression [ Time Frame: Randomization until death or two years post last subject last treatment visit (or clinical cutoff) ] [ Designated as safety issue: No ]
  
• Overall Survival [ Time Frame: Randomization until death or two years post last subject last treatment visit (or clinical cutoff) ] [ Designated as safety issue: No ]
  
• Achievement of Successful Engraftment After Bone Marrow Transplant [ Time Frame: Randomization until death or two years post last subject last treatment visit (or clinical cutoff) ] [ Designated as safety issue: No ]
  

The established treatment for newly diagnosed multiple myeloma is vincristine + adriamycin + intermittent high-dose dexamethasone therapy, but it requires a 96-hour continuous infusion of conventional doxorubicin. Newer options can be administered in an out-patient setting, which is more convenient for patients. However, the optimal regimen in producing a high rate of complete response and durable response remains to be established. This is a multi-center, open-label, randomized (patients are assigned different treatment sbased on chance) study to compare the safety and effectiveness of Thalidomide + Dexamethasone vs. DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone in patients with newly diagnosed multiple myeloma. Treatments are administered in 28-day cycles. Patients will receive 4-12 cycles, depending on the response of their multiple myeloma to the treatment they receive (measured according to the European Group for Blood and Marrow Transplant Response Criteria). Thalidomide + Dexamethasone treatment is as follows: Thalidomide by mouth every night without food on Days 1-28. Dosing will be gradually increased during Cycle 1: 50 mg on Days 1-7, 100 mg on Days 8-14, 150 mg on Days 15-21, and 200 mg on Days 22-28. Thereafter, 200 mg daily will be administered for all subsequent cycles. Dexamethasone will be given at 40 mg by mouth on Days 1-4, Days 9-12 and Days 17-20. DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone treatment is as follows: Thalidomide and Dexamethasone will be administered in the same way as described for the Thalidomide + Dexamethasone treatment group. DOXIL (doxorubicin HCl liposome injection) will be administered on Day 1 via intravenous infusion of 40 mg/m2 over 60 minutes (Cycle 1 infusion is over 90 minutes). Patients will be assessed for safety and efficacy by standard evaluations for patients with multiple myeloma at each cycle. Patients will have additional tests that include Multiple Gated Acquisition (MUGA) scans or echocardiograms to assess the patients for potential cardiotoxicity that could be related to treatment with DOXIL (doxorubicin HCl liposome injection) . The study hypothesis is that the DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone treatment will be more effective in the treatment of newly diagnosed multiple myeloma than the Thalidomide + Dexamethasone treatment, as measured by number of complete responses and will be generally well-tolerated. Specific dose adjustments can be made to Thalidomide and/or DOXIL (doxorubicin HCl liposome injection) based upon toxicity. Maximum duration of study participation for patients would be 48 weeks.