Clinical Trial: Filgrastim Compared With Sargramostim Plus Chemotherapy, Peripheral Stem Cell Transplantation, and Interferon alfa in Treating Patients With Multiple Myeloma

This study has been completed.

Sponsored by: University of Minnesota Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony-stimulating factors such as filgrastim and sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Interferon alfa may interfere with the growth of cancer cells. It is not yet known which treatment regimen is more effective for multiple myeloma.

PURPOSE: Randomizedphase II trial to compare the effectiveness of filgrastim with that of sargramostim plus chemotherapy, peripheral stem cell transplantation, and interferon alfa in treating patients who have multiple myeloma.

Condition Treatment or Intervention Phase
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
 Drug: carmustine
 Drug: cyclophosphamide
 Drug: dexamethasone
 Drug: etoposide
 Drug: filgrastim
 Drug: interferon alfa
 Drug: mitoxantrone
 Drug: sargramostim
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: high-dose chemotherapy
 Procedure: interferon therapy
 Procedure: peripheral blood stem cell transplantation
 Procedure: radiation therapy
Phase II

MedlinePlus related topics:  Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Randomized Study of Filgrastim (G-CSF) Versus Sargramostim (GM-CSF) Plus High-Dose Chemotherapy Followed by Autologous Peripheral Stem Cell Transplantation Followed by Interferon alfa in Patients With Multiple Myeloma

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

  • Arm I: In the priming phase, patients receive cyclophosphamide IV over 2 hours on day 1, mitoxantrone IV over 1 hour daily on days 1-2, and dexamethasone IV every 12 hours beginning on day 1 for a total of 4 doses. Patients also receive sargramostim (GM-CSF) IV over 2 hours or subcutaneously (SC) daily beginning 48 hours after the last dose of mitoxantrone and continuing until completion of leukapheresis. Peripheral blood stem cells (PBSC) are collected daily on days 11-13 after neutrophil recovery.
  • Arm II: In the priming phase, patients receive the same treatment as in arm I except these patients receive filgrastim (G-CSF) IV over 15 minutes or SC in place of GM-CSF. In the transplant phase, patients who have not received prior radiotherapy receive cyclophosphamide IV over 2 hours daily on days -6 and -5 and total body irradiation twice daily on days -3 through -1. Autologous PBSC are reinfused on day 0. Patients also receive GM-CSF IV over 2 hours daily and G-CSF IV over 15 minutes daily beginning on day 0 and continuing until day 28 or until blood counts recover.

Patients who have received prior radiotherapy receive cyclophosphamide IV over 2 hours daily on days -6 through -3, carmustine IV over 1 hour on day -6, and etoposide IV over 4 hours every 12 hours for a total of 6 doses on days -6 through -4. Autologous PBSC are reinfused on day 0. Patients also receive GM-CSF IV over 2 hours daily and G-CSF IV over 15 minutes daily beginning on day 0 and continuing until day 28 or until blood counts recover.

All patients then receive interferon alfa SC 3 times weekly starting on day 28 and continuing until relapse or disease progression.

Patients may also undergo radiotherapy 5 days a week for 2 weeks for residual bony lesions measuring greater than 2 cm.

Patients are followed at days 28 and 100, and at 6, 9, 12, 18, 24, 30, and 36 months.

PROJECTED ACCRUAL: A total of 25-35 patients will be accrued for this study within 2-3 years.

Eligibility

Ages Eligible for Study:  up to  70 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age:

  • 70 and under

Performance status:

  • Age 65-70 years:
  • Karnofsky 80-100%
  • Under 65 years:
  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Hemoglobin at least 8 g/dL (untransfused)
  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3 (untransfused)

Hepatic:

  • Bilirubin less than 2.0 mg/dL
  • ALT less than 3 times upper limit of normal

Renal:

  • Age 65-70 years:
  • Creatinine clearance greater than 60 mL/min (if creatinine at least 1.5 mg/dL)
  • Under 65 years:
  • Creatinine less than 2 mg/dL

Cardiovascular:

  • Age 65-70 years:
  • LVEF at least 45%
  • Under 65 years:
  • No active ischemia
  • LVEF greater than 45% by MUGA

Pulmonary:

  • Age 65-70 years:
  • If history of smoking or respiratory symptoms, spirometry and DLCO must be greater than 50% of predicted
  • Under 65 years:
  • FEV_1 and FVC greater than 60% predicted
  • DLCO greater than 50% of predicted

Other:

  • No active or uncontrolled infection

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • Not specified

Location Information


Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States

Study chairs or principal investigators

Daniel J. Weisdorf, MD,  Study Chair,  University of Minnesota Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067976; UMN-MT-9216; UMN-MT-1992-16
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00005987
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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