MYELOMA VII MEDICAL RESEARCH COUNCIL WORKING PARTY ON LEUKEMIA IN ADULTS: MYELOMATOSIS THERAPY TRIAL
filgrastim
+ recombinant interferon alfa
+ sargramostim
Troubles des Protéines Sanguines+12
+ Maladies Cardiovasculaires
+ Maladies Hématologiques
Étude thérapeutique
Résumé
Date de début de l'étude : 1 septembre 1994
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.750 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Jusqu'à 64 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Leeds Teaching Hospital Trust
Leeds, United KingdomOuvrir Leeds Teaching Hospital Trust dans Google Maps