Bone Marrow Transplantation in Treating Patients With Multiple Myeloma, Chronic Phase Chronic Myelogenous Leukemia, or Agnogenic Myeloid Metaplasia

Allogeneic Bone Marrow Transplantation for Patients With Chronic Myelogenous Leukemia in the Chronic Phase or Multiple Myeloma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004181

Enrollment

Unknown

Registered

2003-01-27

Start date

1999-10-31

Completion date

2004-08-31

Last updated

2012-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloproliferative Disorders, Leukemia, Multiple Myeloma and Plasma Cell Neoplasm

Keywords

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

Brief summary

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.

Detailed description

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.

Interventions

DRUGbusulfan

DRUGcyclophosphamide

PROCEDUREallogeneic bone marrow transplantation

RADIATIONradiation therapy

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

15 Years to 55 Years

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026