Conditions: Multiple Myeloma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: no

Brief summary:
Add three drugs, bortezomib, thalidomide, and dexamethasone (VTD) to the high dose chemotherapy regimen immediately before transplant (DPACE/Melphalan) to try to improve myeloma response and acquire longer survival for participants.

Detailed description:

Arms:
arm 1: DPACE Induction, Melphalan/DPACE Transplant 1, BEAM Transplant 2, DPACE Consolidation, Dexamethasone Maintenance with Interim dexamethasone between treatment phases arm 2: DPACE Induction, Melphalan/DPACE + VTD Transplant 1, BEAM + VTD Transplant 2, DPACE Consolidation, Dexamethasone Maintenance with Interim dexamethasone between treatment phases

Interventions: intervention 1: Interim/Maintenance Dexamethasone intervention 2: Induction/Consolidation Dexamethasone intervention 3: Induction/Consolidation Cisplatin intervention 4: Induction/Consolidation Adriamycin intervention 5: InductionConsolidation Cyclophosphamide intervention 6: Induction/Consolidation Etoposide intervention 7: Induction Pegfilgrastim intervention 8: Transplant 1 Dexamethasone intervention 9: Transplant 1 Cisplatin intervention 10: Transplant 1 Adriamycin intervention 11: Transplant 1 Cyclophosphamide intervention 12: Transplant 1 Etoposide intervention 13: Transplant 1 Melphalan intervention 14: Transplant 1 and 2 Pegfilgrastim intervention 15: Autologous Peripheral Blood Stem Cell Transplant (ASCT) intervention 16: Transplant 2 Carmustine intervention 17: Transplant 2 Etoposide intervention 18: Transplant 2 Cytarabine intervention 19: Transplant 2 Melphalan intervention 20: Transplant 2 Dexamethasone intervention 21: Transplant 1 and 2 Bortezomib intervention 22: Transplant 1 and 2 Thalidomide
Intervention descriptions: intervention 1: 20 mg Days 1-4 every 3 weeks in the interim between treatment phases and during maintenance intervention 2: 40 mg Days 1-4 intervention 3: 10 mg/m2 by continuous infusion Days 1-4 intervention 4: 10 mg/m2 by continuous infusion Days 1-4 intervention 5: 400 mg/m2 by continuous infusion Days 1-4 intervention 6: 40 mg/m2 by continuous infusion Days 1-4 intervention 7: 6 mg Days 6 and 13 intervention 8: 20 mg Days -4, -3, -2, -1 and +4, +5, +6, and +7 intervention 9: 20 mg/m2 by continuous infusion Days -3 and -2 intervention 10: 20 mg/m2 by continuous infusion Days -3 and -2 intervention 11: 800 mg/m2 by continuous infusion Days -3 and -2 intervention 12: 80 mg/m2 by continuous infusion Days -3 and -2 intervention 13: 50 mg/m2 Days -2 and -1 intervention 14: 6 mg Day +6 intervention 15: Day 0 intervention 16: 300 mg/m2 Day -5 intervention 17: 200 mg/m2 Days -5, -4, -3, -2 intervention 18: 400 mg/m2 Days -5, -4, -3, -2 intervention 19: 140 mg/m2 Day -1 intervention 20: 20 mg Days -5, -4, -3, -2, +4, +5, +6, +7 intervention 21: 1 mg/m2 Days -4, -1, +3, +7 intervention 22: 200 mg Days -4 to +5

Protocol document: