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Phase II to Treat Multiple Myeloma Patients With Cytoxan and Vincristine After Cycling Myeloma Cells With rHuGM-CSF

Phase 2
16 Years
Open (Enrolling)
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

Phase II to Treat Multiple Myeloma Patients With Cytoxan and Vincristine After Cycling Myeloma Cells With rHuGM-CSF

OBJECTIVES: I. Determine the response rate of multiple myeloma patients when treated with
cyclophosphamide and vincristine after cycling myeloma cells with sargramostim (GM-CSF). II.
Evaluate whether Labelling Index (LI) changes influenced by GM-CSF would predict a group of
patients that will respond to this particular course specific design. III. Determine the
toxicity of GM-CSF in these patients.

OUTLINE: Patients receive subcutaneous injections of sargramostim (GM-CSF) once a day for 5
days. Two to 3 days later, patients receive cyclophosphamide IV over 30-45 minutes on day 1,
vincristine IV bolus on day 8, and oral prednisone 4 times a day on days 1-4. Patients also
receive subcutaneous injections of GM-CSF starting on day 2 and continuing for 10 days or
until neutrophil count is at least 1000/mm3. Treatment continues every 3 weeks for a minimum
of 6 courses in the absence of disease progression or unacceptable toxicity. Patients who
achieve at least stable response receive GM-CSF 3 times a week for up to 2 years. Patients
are followed every 3-6 months.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven multiple myeloma Pancytopenia related to
multiple myeloma allowed Failed or progressed after at least 2 chemotherapy or biologic
therapy regimens

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Platelet count at least 50,000/mm3 Absolute
neutrophil count at least 750/mm3 Hepatic: SGOT/SGPT less than 3 times upper limit of
normal Bilirubin less than 5.0 mg/dL Renal: Not specified Other: No active infection
requiring intravenous antibiotics Not HIV positive Not pregnant or nursing Fertile
patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics May have failed
prior bone marrow transplant No other concurrent colony stimulating factors Concurrent
immunoglobulin allowed Chemotherapy: See Disease Characteristics Concurrent pamidronate
allowed Endocrine therapy: Not specified Radiotherapy: Concurrent standard radiation
therapy to treat extra-skeletal and/or skeletal tumor sites allowed Surgery: Not specified
Other: Concurrent epoetin alfa for anemia allowed

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Mohamad A. Hussein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:




Start Date:

October 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



Cleveland Clinic Cancer Center Cleveland, Ohio  44195