Autologous Transplantation With High Dose BCNU and Melphalan Followed by Consolidation With DCEP and Taxol/Cisplatin in Patients With Multiple Myeloma and < or = 12 Months of Standard Therapy
OBJECTIVES: I. Evaluate the complete and partial response in multiple myeloma patients
receiving peripheral blood stem cells supported by high dose carmustine and melphalan
followed by consolidation therapy with cyclophosphamide/dexamethasone/etoposide/cisplatin
(DCEP) and paclitaxel/cisplatin. II. Evaluate the incidence of early death in comparison
with historical data in this patient population. III. Evaluate the feasibility of
chemotherapy with DCEP and paclitaxel/cisplatin following autotransplantation in these
patients.
OUTLINE: Patients receive carmustine IV over 2 hours on day -2, followed by melphalan IV
over 20 minutes on day -1. Patients receive intravenous CD34 peripheral blood stem cells on
day 0. At 3 months and 9 months, patients with adequate hematologic counts receive
cyclophosphamide IV, oral dexamethasone, etoposide IV, and cisplatin IV for 4 days. At 6 and
12 months after autotransplantation, patients with adequate peripheral blood counts and
creatinine receive oral dexamethasone on days 1-4, paclitaxel IV over 6 hours on day 2, and
cisplatin IV over 24 hours on day 3. Patients are followed every 6 weeks to 3 months until
death.
PROJECTED ACCRUAL: Approximately 24-63 patients will be accrued for this study within 2.5
years.
Interventional
Primary Purpose: Treatment
Barry R. Meisenberg, MD
Study Chair
University of Maryland Greenebaum Cancer Center
United States: Federal Government
CDR0000066402
NCT00003399
September 1998
Name | Location |
---|---|
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |