Conditions: Multiple Myeloma
Keywords: Multiple Myeloma DTPACE Tandem Transplant Cisplatin Cyclophosphamide Dexamethasone Doxorubicin Etoposide Sargramostim Thalidomide Melphalan
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 97
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Autologous transplant with High Dose Melphalan alone arm 2: Melphalan plus Dexamethasone, Thalidomide, CisPlatinum, Adriamycin, Cyclophosphamide, and Etoposide

Interventions: intervention 1: Cisplatin intervention 2: Cyclophosphamide intervention 3: Adriamycin intervention 4: Etoposide intervention 5: Melphalan intervention 6: Thalidomide intervention 7: Dexamethasone
Intervention descriptions: intervention 1: 20mg/m2 continuous infusion days -3 and -2. intervention 2: 800 mg/m2 continuous infusion days -3 and -2. intervention 3: 20mg/m2 continuous infusion -3 and -2. intervention 4: 80mg/m2 continuous infusion -3 and -2. intervention 5: 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. intervention 6: 200mg PO Continuing to Day +5, then hold until platelets \>50 thousand (K). intervention 7: 40 mg po days 1 - 4 (4 days)

Protocol document: