Combination Chemotherapy and Interferon Alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma
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|ClinicalTrials.gov Identifier: NCT00002599|
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : May 21, 2004
Last Update Posted : December 19, 2013
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 or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Biological: filgrastim Biological: recombinant interferon alfa Biological: sargramostim Drug: carmustine Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: melphalan Drug: methylprednisolone Drug: prednisone Drug: vincristine sulfate Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy||Phase 3|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|Official Title:||MYELOMA VII MEDICAL RESEARCH COUNCIL WORKING PARTY ON LEUKEMIA IN ADULTS: MYELOMATOSIS THERAPY TRIAL|
|Study Start Date :||September 1994|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002599
|Leeds Teaching Hospital Trust|
|Leeds, England, United Kingdom, LS1 3EX|
|Study Chair:||J. A. Child, MD||Leeds General Infirmary|