Allogeneic Bone Marrow Transplantation for Patients With Chronic Myelogenous Leukemia in the Chronic Phase or Multiple Myeloma
busulfan
+ cyclophosphamide
+ allogeneic bone marrow transplantation
Troubles des Protéines Sanguines+23
+ Maladies de la moelle osseuse
+ Maladies Cardiovasculaires
Étude thérapeutique
Résumé
Date de début de l'étude : 1 octobre 1999
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the efficacy of allogeneic bone marrow transplantation (BMT) following high-dose cyclophosphamide and total body irradiation in patients with multiple myeloma, agnogenic myeloid metaplasia, or chronic myelogenous leukemia in first or second chronic phase. Determine the efficacy of BMT following busulfan and cyclophosphamide in these patients. Determine the toxic effects of these preparative regimens in these patients. OUTLINE: Patients are stratified by remission (first vs second vs third). Patients who have not undergone prior radiotherapy receive cyclophosphamide IV on days -6 and -5 and then undergo total body irradiation twice a day on days -4 to -1. Allogeneic bone marrow is infused on day 0. Patients who have undergone prior radiotherapy receive oral busulfan every 6 hours on days -7 to -4 or -6 to -3 and cyclophosphamide IV over 2 hours on days -3 and -2. Allogeneic bone marrow is infused on day 0. Patients are followed at days 30 and 90, at 6 months, and then annually thereafter. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 2 years.
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.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.De 15 à 55 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: Cytologically proven disease of one of the following types with transfusion-dependent anemia or thrombocytopenia (less than 50,000/mm^3): Multiple myeloma Agnogenic myeloid metaplasia Chronic myelogenous leukemia in first or second chronic phase Philadelphia chromosome with BCR gene rearrangement Suitable sibling bone marrow donor available PATIENT CHARACTERISTICS: Age: 15 to physiologic 55 Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT less than 2 times normal Alkaline phosphatase less than 2 times normal Renal: Creatinine less than 2 mg/dL Cardiovascular: Ejection fraction normal by MUGA No acute myocardial infarction within the past 6 months No active angina pectoris No active congestive heart failure Pulmonary: FEV greater than 50% predicted DLCO at least 50% Other: HIV negative No active infection No concurrent organ damage or medical problems that would preclude therapy PRIOR CONCURRENT THERAPY: Not specified
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
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, United StatesOuvrir Robert H. Lurie Comprehensive Cancer Center at Northwestern University dans Google Maps