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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


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

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Trial Information

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
death.

PROJECTED ACCRUAL: Approximately 24-63 patients will be accrued within 2.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven multiple myeloma with 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
4,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 4
times upper limit of normal No active or 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:

CDR0000066405

NCT ID:

NCT00003401

Start Date:

January 1999

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 MarylandBaltimore, Maryland  21201