Allogeneic Bone Marrow Transplantation for Patients With Chronic Myelogenous Leukemia in the Chronic Phase or Multiple Myeloma
15 Years
55 Years
Both
Chronic Myeloproliferative Disorders, Leukemia, Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
Allogeneic Bone Marrow Transplantation for Patients With Chronic Myelogenous Leukemia in the Chronic Phase or Multiple Myeloma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Martin S. Tallman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Robert H. Lurie Cancer Center
Authority:
United States: Federal Government
Study ID:
NU 92H3T
NCT ID:
NCT00004181
Start Date:
October 1999
Completion Date:
August 2004
Related Keywords:
- Chronic Myeloproliferative Disorders
- Leukemia
- Multiple Myeloma and Plasma Cell Neoplasm
- refractory multiple myeloma
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- chronic phase chronic myelogenous leukemia
- chronic idiopathic myelofibrosis
- Philadelphia chromosome positive chronic myelogenous leukemia
- Primary Myelofibrosis
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Myeloid, Chronic-Phase
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myeloproliferative Disorders
Name | Location |
|---|---|
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
