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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004181
• Other study ID #: NU 92H3T
• Secondary ID: NU-92H3TNCI-G99-
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2000
• Last updated: June 8, 2012
• Start date: October 1999
• Est. completion date: August 2004

Study information

• Verified date: June 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 55 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• busulfan

• cyclophosphamide

Procedure:
• allogeneic bone marrow transplantation

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,