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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002556 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether combination chemotherapy plus interferon alfa is more effective than combination chemotherapy alone in treating patients with multiple myeloma.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without interferon alfa in treating patients who have previously untreated stage I, stage II, or stage III multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Biological: filgrastim Biological: recombinant interferon alfa Drug: carmustine Drug: cyclophosphamide Drug: melphalan Drug: prednisone Drug: vincristine sulfate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | THE TREATMENT OF MULTIPLE MYELOMA UTILIZING VBMCP CHEMOTHERAPY ALTERNATING WITH HIGH-DOSE CYCLOPHOSPHAMIDE AND ALPHA 2B-INTERFERON VERSUS VBMCP: A PHASE III STUDY FOR PREVIOUSLY UNTREATED MULTIPLE MYELOMA |
Estimated Enrollment: | 289 |
Study Start Date: | April 1994 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to creatinine (less than 2.0 vs 2.0 mg/dL or greater), performance status (0-1 vs 2-4), plasma cell labeling index (2% or more vs less than 2% vs approved unknown/not interpretable), and beta-2 microglobulin (4 micrograms/dL or greater vs less than 4 micrograms/dL vs approved unknown/not interpretable).
Consolidation: Patients are then randomized to 1 of 2 treatment arms.
After documentation of plateau, patients receive 2 additional courses of VBMCP (arm I) or 2 additional courses of VBMCP alternating with 2 courses of IFN-A (arm II) in the absence of disease progression. Treatment for arms I and II continues for 1-2 years in the absence of a plateau state plus 2 additional courses of VBMCP (arm I) or 2 courses each of VBMCP and IFN-A (arm II); disease progression; or unacceptable toxicity. Patients undergo observation beginning after completion of the 2 post-plateau courses and continuing in the absence of disease progression. Patients with disease progression after 3 months on observation receive reinduction comprising the consolidation regimen to which they were originally randomized. Reinduction continues in the absence of disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 289 patients will be accrued for this study within approximately 8 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of previously untreated, stage I-III multiple myeloma confirmed by:
At least 1 of the following:
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
No significant arrhythmia within the past 3 months, i.e.:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Illinois | |
CCOP - Illinois Oncology Research Association | |
Peoria, Illinois, United States, 61602 | |
United States, Wisconsin | |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | |
Green Bay, Wisconsin, United States, 54301 |
Study Chair: | Robert A. Kyle, MD | Mayo Clinic |
Study ID Numbers: | CDR0000063435, E-5A93 |
Study First Received: | November 1, 1999 |
Last Updated: | March 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00002556 History of Changes |
Health Authority: | United States: Federal Government |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Anti-Inflammatory Agents Prednisone Melphalan Interferon Type I, Recombinant Immunologic Factors Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Paraproteinemias Cyclophosphamide Hemostatic Disorders Hormones Hemorrhagic Disorders Alkylating Agents Interferon-alpha |
Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Interferons Carmustine Vascular Diseases Vincristine Antimitotic Agents Glucocorticoids Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Multiple Myeloma Tubulin Modulators |
Anti-Inflammatory Agents Anti-Infective Agents Prednisone Interferon Type I, Recombinant Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Paraproteinemias Cyclophosphamide Hemostatic Disorders Hormones Hemorrhagic Disorders |
Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Alkylating Agents Interferon-alpha Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Growth Substances Mitosis Modulators Interferons Carmustine |