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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.

Sponsors and Collaborators: Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004181
  Purpose

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.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Leukemia
Multiple Myeloma and Plasma Cell Neoplasm
Drug: busulfan
Drug: cyclophosphamide
Procedure: allogeneic bone marrow transplantation
Procedure: radiation therapy
Phase II

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Multiple Myeloma    Spleen Diseases   

ChemIDplus related topics:   Cyclophosphamide    Busulfan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Allogeneic Bone Marrow Transplantation for Patients With Chronic Myelogenous Leukemia in the Chronic Phase or Multiple Myeloma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   October 1999

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.

  Eligibility
Ages Eligible for Study:   15 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004181

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University    
      Chicago, Illinois, United States, 60611

Sponsors and Collaborators
Robert H. Lurie Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Martin S. Tallman, MD     Robert H. Lurie Cancer Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067417, NU-92H3T, NCI-G99-1639
First Received:   January 21, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004181
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory plasma cell neoplasm  
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

Study placed in the following topic categories:
Philadelphia Chromosome
Chronic myelogenous leukemia
Paraproteinemias
Cyclophosphamide
Leukemia, Myeloid, Chronic-Phase
Hemostatic Disorders
Leukemia
Myelofibrosis-osteosclerosis
Hemorrhagic Disorders
Multiple myeloma
Metaplasia
Chronic Myeloproliferative Disorders
Myelofibrosis
Immunoproliferative Disorders
Hematologic Diseases
Blood Coagulation Disorders
Myeloproliferative Disorders
Vascular Diseases
Leukemia, Myeloid
Multiple Myeloma
Myeloid Metaplasia
Lymphatic Diseases
Busulfan
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Cardiovascular Diseases
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Splenic Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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