Clinical Trial: Combination Chemotherapy and Interferon alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma

This study is no longer recruiting patients.

Sponsored by: Medical Research Council
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow or peripheral stem cell transplantation with chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether a more intensive chemotherapy regimen plus stem cell or bone marrow transplant is more effective than standard chemotherapy in treating patients with myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy plus interferon alfa with or without high dose melphalan or bone marrow or peripheral stem cell transplantation in treating patients with previously untreated myeloma.

Condition Treatment or Intervention Phase
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
 Drug: carmustine
 Drug: cyclophosphamide
 Drug: doxorubicin
 Drug: filgrastim
 Drug: interferon alfa
 Drug: melphalan
 Drug: methylprednisolone
 Drug: prednisone
 Drug: sargramostim
 Drug: vincristine
Phase III

MedlinePlus related topics:  Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Standard Therapy with ABCM (DOX/BCNU/CTX/L-PAM) vs Intensive Therapy with C-VAMP (CTX/VCR/DOX/MePRDL) Followed by High-Dose L-PAM (with or without TBI) with Hematopoietic Rescue, Both with IFN-A Maintenance, for Previously Untreated Myeloma

Further Study Details: 

Study start: September 1994

OBJECTIVES: I. Compare survival of patients under age 65 with myeloma treated with standard ABCM (doxorubicin, carmustine, cyclophosphamide, melphalan) vs. intensive C-VAMP (cyclophosphamide, vincristine, doxorubicin, methylprednisolone) followed by high-dose melphalan (with or without total-body irradiation) with bone marrow and peripheral blood stem cell support, both with IFN-A maintenance. II. Compare the toxicity profiles of the 2 treatment arms. III. Compare the 2 treatment arms with respect to quality of life and health economics issues. IV. Investigate cellular changes by means of linked morphology, phenotype, and cytogenetics studies before and after treatment and at relapse.

PROTOCOL OUTLINE: Randomized study. The following acronyms are used: ABM Autologous Bone Marrow BCNU Carmustine, NSC-409962 CTX Cyclophosphamide, NSC-26271 DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony Stimulating Factor (Amgen), NSC-614629 GM-CSF Granulocyte-Macrophage Colony Stimulating Factor (source not specified) IFN-A Interferon alpha (Hoffmann-La Roche), NSC-367982 L-PAM Melphalan, NSC-8806 MePRDL Methylprednisolone, NSC-19987 PBSC Peripheral Blood Stem Cells PRED Prednisone, NSC-10023 TBI Total-Body Irradiation VCR Vincristine, NSC-67574 ARM I. Induction: 4-Drug Combination Chemotherapy or, as indicated, 2-Drug Combination Chemotherapy. ABCM: DOX; BCNU; CTX; L-PAM; or, if pretreatment ANC and platelets are less than 1,300 and 75,000, CTX; PRED. Maintenance: Biological Response Modifier Therapy. IFN-A. ARM II. Induction: 4-Drug Combination Chemotherapy followed by Hematopoietic Stimulation. C-VAMP: DOX; VCR; MePRDL; CTX; followed by CTX; G-CSF or GM-CSF. Consolidation: 3-Drug Combination Chemoablation with or without Radioablation followed by Hematopoietic Rescue. CTX; L-PAM; MePRDL; with or without TBI using megavoltage equipment (linear accelerator preferred); followed by ABM and/or PBSC. Maintenance: Biological Response Modifier Therapy. IFN-A.

PROJECTED ACCRUAL: 750 patients will be accrued.

Eligibility

Ages Eligible for Study:  up to  64 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

--Patient Characteristics--

  • Age: Under 65
  • Performance status: Not specified
  • Hematopoietic: (following rehydration and treatment for infection, if necessary); ANC at least 1,000 Platelets at least 50,000
  • Hepatic: Not specified
  • Renal: Renal insufficiency does not necessarily exclude (dose reduction may be applicable)
  • Cardiovascular: No severe cardiac disease; Past history of ischemic heart disease may exclude at the discretion of the investigator
  • Pulmonary: No severe respiratory illness
  • Other: Ability to tolerate at least 3 liters/day of fluid; No life-threatening disease unrelated to myeloma; Prior or concurrent psychiatric disorder may exclude at the discretion of the investigator; No prior malignancy except: Nonmelanomatous skin tumors In situ carcinomas

Location Information


United Kingdom, England
      Leeds Teaching Hospital Trust, Leeds,  England,  LS1 3EX,  United Kingdom

Study chairs or principal investigators

J.A. Child,  Study Chair,  Medical Research Council   

More Information

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

Study ID Numbers:  CDR0000063834; MRC-LEUK-MYEL-VII; EU-94030
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002599
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


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

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