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

This study has been completed.
Study NCT00004181.   Last updated on November 16, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Bone Marrow Transplantation in Treating Patients With Multiple Myeloma, Chronic Phase Chronic Myelogenous Leukemia, or Agnogenic Myeloid Metaplasia
Official Title  Allogeneic Bone Marrow Transplantation for Patients With Chronic Myelogenous Leukemia in the Chronic Phase or Multiple Myeloma
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.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Chronic Myeloproliferative Disorders
Leukemia
Multiple Myeloma and Plasma Cell Neoplasm
Intervention  Drug: busulfan
Drug: cyclophosphamide
Procedure: allogeneic bone marrow transplantation
Procedure: radiation therapy
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  October 1999
Completion Date
Eligibility 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
Gender Both
Ages 15 Years to 55 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00004181
Organization ID CDR0000067417
Secondary IDs †† NU-92H3T, NCI-G99-1639
Study Sponsor  Robert H. Lurie Cancer Center
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Martin S. Tallman, MD     Robert H. Lurie Cancer Center    
Information Provided By National Cancer Institute (NCI)
Verification Date November 2004
First Received Date  January 21, 2000
Last Updated Date November 16, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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