Autologous Transplantation With Gemcitabine and High Dose BCNU Plus Melphalan Followed by Consolidation With DCEP Plus Gemcitabine and Taxol/Cisplatin in Patients With Multiple Myeloma and >12 Months of Standard Therapy
OBJECTIVES: I. Evaluate the complete and partial response in multiple myeloma patients
receiving peripheral blood stem cells supported by gemcitabine and high dose carmustine and
melphalan followed by consolidation therapy with gemcitabine plus
cyclophosphamide/dexamethasone/etoposide/cisplatin (DCEP) and
dexamethasone/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 gemcitabine plus DCEP and dexamethasone/paclitaxel/cisplatin following
autotransplantation in these patients.
OUTLINE: Patients receive gemcitabine IV over 100 minutes on day -5 and again 6 hours after
administration of 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. On day 3 of continuous
infusions, gemcitabine is given over 100 minutes. At 6 and 12 months after autotransplant,
patients 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
PROJECTED ACCRUAL: Approximately 24-63 patients will be accrued within 2.5 years.
Primary Purpose: Treatment
Barry R. Meisenberg, MD
University of Maryland Greenebaum Cancer Center
United States: Federal Government
|Marlene & Stewart Greenebaum Cancer Center, University of Maryland||Baltimore, Maryland 21201|