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
18 Years
70 Years
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
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.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven multiple myeloma with no greater than 12
months of prior therapy Bone marrow plasmacytosis at least 30% or protein criteria present
No obvious myelodysplastic changes in the bone marrow No CNS disease
PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: SWOG 0-2 (3-4 acceptable if
based solely on bone pain) Life expectancy: Not specified Hematopoietic: CD34+ at least 4
million/kg Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 4
times upper limit of normal No active chronic hepatitis or liver cirrhosis Renal:
Creatinine no greater than 3.0 mg/dL Cardiovascular: LVEF greater than 50% Pulmonary: FEV1
or FVC at least 50% of predicted DLCO at least 50% of predicted Patients unable to
complete pulmonary function tests must have a CT scan of the chest and acceptable arterial
blood gases of PO2 greater than 70 Other: Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception HIV negative No active infection
requiring IV antibiotics
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy Endocrine therapy: Prior steroid therapy allowed Radiotherapy: At
least 4 weeks since prior radiotherapy Surgery: Not specified
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Barry R. Meisenberg, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Maryland Greenebaum Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000066402
NCT ID:
NCT00003399
Start Date:
September 1998
Completion Date:
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- refractory multiple myeloma
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
