Trial Information

A Randomized, Open-Label, Multi-Center Trial Comparing Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL� -Thal-Dex) in Subjects With Newly Diagnosed Multiple Myeloma

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.