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

Sponsor:	Northwestern University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Northwestern University
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 Radiation: radiation therapy	Phase II

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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia primary myelofibrosis

MedlinePlus related topics: Bone Marrow Transplantation Cancer Chronic Myeloid Leukemia Leukemia Multiple Myeloma

Drug Information available for: Cyclophosphamide Busulfan

U.S. FDA Resources

Further study details as provided by Northwestern University:

Study Start Date:	October 1999
Study Completion Date:	August 2004
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

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

Northwestern University

National Cancer Institute (NCI)

Investigators

Study Chair:

Martin S. Tallman, MD

Robert H. Lurie Cancer Center

More Information

Additional Information:

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

No publications provided

Responsible Party:	Martin Tallman, MD, Northwestern University
ClinicalTrials.gov Identifier:	NCT00004181 History of Changes
Other Study ID Numbers:	NU 92H3T, NU-92H3T, NCI-G99-1639
Study First Received:	January 21, 2000
Last Updated:	February 16, 2011
Health Authority:	United States: Federal Government

Keywords provided by Northwestern University:

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

Additional relevant MeSH terms:

Primary Myelofibrosis
Neoplasms
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases

Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Busulfan
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on February 12, 2012