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

NCT ID: NCT00004181

Last Updated: 2012-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-10-31
• Study Completion Date: 2004-08-31

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.

Conditions

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

Study Design

• Primary Study Purpose: TREATMENT

Interventions

busulfan

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

allogeneic bone marrow transplantation

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin S. Tallman, MD

Role: STUDY_CHAIR

Robert H. Lurie Cancer Center

Locations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NU-92H3T

Identifier Type: -

Identifier Source: secondary_id

NCI-G99-1639

Identifier Type: -

Identifier Source: secondary_id

NU 92H3T

Identifier Type: -

Identifier Source: org_study_id