Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Chicago, Illinois 60611


Purpose:

RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of allogeneic bone marrow transplantation in treating patients who have multiple myeloma, chronic phase chronic myelogenous leukemia, or agnogenic myeloid metaplasia.


Study summary:

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.


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


NCT ID:

NCT00004181


Primary Contact:

Study Chair
Martin S. Tallman, MD
Robert H. Lurie Cancer Center


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60611
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.