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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

Phase 2
18 Years
70 Years
Not Enrolling
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

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

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

PROJECTED ACCRUAL: Approximately 24-63 patients will be accrued for this study within 2.5

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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Barry R. Meisenberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center


United States: Federal Government

Study ID:




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



Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201