Conditions: Multiple Myeloma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 231
Healthy volunteers: no

Brief summary:
This experimental study evaluates the effects of a series of intensive drug regimens as initial treatment for Multiple Myeloma followed by 2 bone marrow transplantations 4-6 months apart in support of high-dose Melphalan, followed by Interferon treatment indefinitely.

Detailed description:

Arms:
arm 1: Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.

Interventions: intervention 1: VAD intervention 2: High-Dose cyclophosphamide intervention 3: Hemopoietic stem cell procurement intervention 4: EDAP intervention 5: Autologous Hemopoietic Stem Cell Transplant 1 intervention 6: Autologous Hemopoietic Stem Cell Transplant 2 intervention 7: Maintenance
Intervention descriptions: intervention 1: 3 Cycles (3rd cycle optional): Vincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20 intervention 2: Approximately 5-6 weeks after VAD 2 or 3:

Cytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1 intervention 3: Collection target = 10 x 10\^6 cells/kg intervention 4: Approximately 5-6 weeks after high-dose cyclophosphamide Etoposide 100 mg/m2/d d 1 - 4 CI Cisplatin 25 mg/m2/d d 1 - 4 CI Ara C l g/m2 d 5 Dexamethasone 40 mg d 1-5 intervention 5: 4-6 weeks after EDAP: Melphalan 100 mg/m2 days -1 and -2 intervention 6: 4-6 months after Transplant 1: Melphalan 100 mg/m2 days -1 and -2 intervention 7: 3 months after Transplant 2: Intron A 3 X 10\^6 units /m2 M-W-F subcutaneously until relapse

Protocol document: