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


Phase 2
15 Years
55 Years
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Leukemia, Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Martin S. Tallman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 92H3T

NCT ID:

NCT00004181

Start Date:

October 1999

Completion Date:

August 2004

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Multiple Myeloma and Plasma Cell Neoplasm
  • 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
  • Primary Myelofibrosis
  • Neoplasms
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myeloproliferative Disorders

Name

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611