Allogeneic Bone Marrow Transplantation for Patients With Chronic Myelogenous Leukemia in the Chronic Phase or Multiple Myeloma
busulfan
+ cyclophosphamide
+ allogeneic bone marrow transplantation
Blood Protein Disorders+23
+ Bone Marrow Diseases
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: October 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 15 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, United StatesOpen Robert H. Lurie Comprehensive Cancer Center at Northwestern University in Google Maps