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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   Information provided by National Cancer Institute (NCI)
First Received: January 21, 2000   Last Updated: February 6, 2009   History of Changes

January 21, 2000
February 6, 2009
October 1999
 
 
 
Complete list of historical versions of study NCT00004181 on ClinicalTrials.gov Archive Site
 
 
 
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

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.

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.

Phase II
Interventional
Treatment
  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Drug: busulfan
  • Drug: cyclophosphamide
  • Procedure: allogeneic bone marrow transplantation
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
15 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004181
 
CDR0000067417, NU-92H3T, NCI-G99-1639
Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Study Chair: Martin S. Tallman, MD Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
November 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP