The purpose of this study is to find out if transplant with a new regimen of chemotherapy called DT PACE-Melphalan is better than transplant with Melphalan alone. DT-PACE refers to a chemotherapy regimen for multiple myeloma consisting of Dexamethasone, Thalidomide, Cisplatin or Platinol, Adriamycin or doxorubicin, Cyclophosphamide, and Etoposide. Another purpose of this study is to find out if there will be fewer side effects with the new regimen of DT PACE-Melphalan, compared to melphalan alone.
To evaluate, in a randomized phase III clinical trial in previously treated multiple myeloma patients, whether angio-chemotherapy with D.T. PACE followed by tandem transplant with MEL-DTPACE Hybrid may be equivalent or superior to tandem transplant with high dose melphalan in terms of complete remission (CR)/near CR/very good partial remission (VGPR) rate and event-free and overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
97
20mg/m2 continuous infusion days -3 and -2.
800 mg/m2 continuous infusion days -3 and -2.
20mg/m2 continuous infusion -3 and -2.
80mg/m2 continuous infusion -3 and -2.
200 mg/m2 IV over \<20 minutes on -1 on Arm 1. 50mg/m2 IV over 20 minutes days -3 and -2 on Arm 2.
200mg PO Continuing to Day +5, then hold until platelets \>50 thousand (K).
40 mg po days 1 - 4 (4 days)
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States
Transplant With DT PACE-Melphalan Regimen of Chemotherapy vs. Transplant With Melphalan Alone.
Compare a new regimen of chemotherapy called DT PACE-Melphalan (new experimental therapy) is better than transplant with Melphalan alone (standard therapy)
Time frame: 3 years depending on start date
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