A Phase III Study of DTPACE followed by Tandem Transplant with MEL 200 versus MEL/DTPACE Hybrid and DTPACE Consolidation in Patients with Active Multiple Myeloma

III

The objectives of this study are: To evaluate, in a randomized phase III clinical trial in previously treated multiple myeloma patients, whether angio-chemotherapy with DTPACE followed by tandem transplant with MEL-DTPACE Hybrid may be equivalent or superior to tandem transplant with high-dose melphalan in terms of CR/near CR/VGPR rate and event-free and overall survival; and to evaluate whether MEL-DTPACE hybrid has a lower toxicity profile in terms of mortality and/or > grade III nonhematologic toxicity

• The study population includes patients 18 years of age with multiple myeloma, previously treated with chemotherapy, but no prior transplant. Patients must have measurable disease, a PS of 0 to 2 unless based solely on disease-related pain, must have adequate platelet count, adequate pulmonary, renal, and cardiac function, and must be able to receive full doses of chemotherapy in the opinion of the treating investigator. Prior malignancies are not allowed, unless those stated, and must not be pregnant or nursing.

All patients will receive induction chemotherapy with DTPACE, (4-day infusion of Cisplatin, Adriamycin®, cyclophosphamide, and etoposide, as well as dexamethasone by mouth for 4 days and thalidomide every night), followed by peripheral blood stem cell (PBSC) collection. Those able to collect adequate PBSC for 2 transplants will then be randomized to receive tandem autologous transplant with melphalan alone (standard therapy) or tandem autologous transplant with DTPACE-melphalan hybrid (experimental therapy). In between transplant, patients will receive dexamethasone and thalidomide in an attempt to prevent progressive disease. Following transplant 2, as soon as platelet count recovers, all patients will receive 1 additional course of DT PACE as consolidation therapy, followed by maintenance therapy with dexamethasone and thalidomide for 3 years total. The entire length of treatment will take approximately 4 years. Principal Investigator: Guido Tricot, MD, PhD

Arkansas
Wanda MacNeil, BS, CCRP
Myeloma Institute for Research and Therapy
Phone: 501/296-1503 ext 1441
Fax: 501/526-2273