Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	15 to physiologic 55	NCI	NU-92H3T NCI-G99-1639, NCT00004181

Objectives

1. 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.
2. Determine the efficacy of BMT following busulfan and cyclophosphamide in these patients.
3. Determine the toxic effects of these preparative regimens in these patients.

Entry Criteria

Disease Characteristics:

• Cytologically proven disease of one of the following types with transfusion-dependent anemia or thrombocytopenia (less than 50,000/mm³):
  • 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

Prior/Concurrent Therapy:

• Not specified

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

Expected Enrollment

A total of 20-30 patients will be accrued for this study within 2 years.

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.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Martin Tallman, MD, Protocol chair		Ph: 312-695-0990

Registry Information
Official Title		Allogeneic Bone Marrow Transplantation for Patients With Chronic Myelogenous Leukemia in the Chronic Phase or Multiple Myeloma
Trial Start Date		1999-10-27
Registered in ClinicalTrials.gov		NCT00004181
Date Submitted to PDQ		1999-11-01
Information Last Verified		2004-11-08
NCI Grant/Contract Number		P30-CA60553

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