MYELOMA VII MEDICAL RESEARCH COUNCIL WORKING PARTY ON LEUKEMIA IN ADULTS: MYELOMATOSIS THERAPY TRIAL
N/A
64 Years
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
MYELOMA VII MEDICAL RESEARCH COUNCIL WORKING PARTY ON LEUKEMIA IN ADULTS: MYELOMATOSIS THERAPY TRIAL
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
J. A. Child, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Leeds General Infirmary
Authority:
United States: Federal Government
Study ID:
CDR0000063834
NCT ID:
NCT00002599
Start Date:
September 1994
Completion Date:
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|
