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Combination Chemotherapy and Interferon Alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma

This study is ongoing, but not recruiting participants.

Sponsored by: Medical Research Council
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002599
  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 Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: carmustine
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: filgrastim
Drug: melphalan
Drug: methylprednisolone
Drug: prednisone
Drug: recombinant interferon alfa
Drug: sargramostim
Drug: vincristine sulfate
Procedure: low-LET cobalt-60 gamma ray therapy
Procedure: low-LET photon therapy
Phase III

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Cancer    Multiple Myeloma   

Drug Information available for:   Doxorubicin    Doxorubicin hydrochloride    Cyclophosphamide    Filgrastim    Carmustine    Melphalan    Methylprednisolone    Prednisone    Vincristine sulfate    Vincristine    Sargramostim    Granulocyte-macrophage colony-stimulating factor    Interferon alfa-n1    Interferon alfa-2a    Interferon alfa-2b    Interferons    Melphalan hydrochloride    Sarcolysin    Cobalt   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   MYELOMA VII MEDICAL RESEARCH COUNCIL WORKING PARTY ON LEUKEMIA IN ADULTS: MYELOMATOSIS THERAPY TRIAL

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   750
Study Start Date:   September 1994

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   up to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Definite myeloma requiring chemotherapy and fulfilling at least 2 of the following criteria: Neoplastic plasma cell infiltrate and/or microplasmacytomas on bone marrow aspiration and/or trephine Paraprotein in blood and/or urine Definite lytic bone lesions (not simply osteoporosis) No equivocal myeloma (such patients should be registered with the Clinical Trial Service Unit, Oxford)

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

PRIOR CONCURRENT THERAPY: No prior therapy other than minimal local radiotherapy for relief of bone pain

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002599

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

Sponsors and Collaborators
Medical Research Council

Investigators
Study Chair:     J. A. Child, MD     Leeds General Infirmary    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000063834, MRC-LEUK-MYEL-VII, EU-94030
First Received:   November 1, 1999
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00002599
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma  
stage II multiple myeloma  
stage III multiple myeloma  

Study placed in the following topic categories:
Prednisone
Melphalan
Interferon Type I, Recombinant
Blood Protein Disorders
Methylprednisolone
Prednisolone acetate
Paraproteinemias
Cyclophosphamide
Hemostatic Disorders
Leukemia
Hemorrhagic Disorders
Multiple myeloma
Cobalt
Methylprednisolone Hemisuccinate
Interferon-alpha
Immunoproliferative Disorders
Hematologic Diseases
Blood Coagulation Disorders
Interferons
Carmustine
Vascular Diseases
Methylprednisolone acetate
Vincristine
Doxorubicin
Multiple Myeloma
Prednisolone
Lymphoproliferative Disorders
Interferon Alfa-2a
Interferon Alfa-2b
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Antibiotics, Antineoplastic
Hormones
Neuroprotective Agents
Therapeutic Uses
Cardiovascular Diseases
Angiogenesis Modulating Agents
Growth Inhibitors
Alkylating Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Growth Substances
Mitosis Modulators
Gastrointestinal Agents
Antimitotic Agents
Glucocorticoids
Protective Agents
Angiogenesis Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms

ClinicalTrials.gov processed this record on November 20, 2008




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