Fludarabine, Busulfan, Antithymocyte Globulin, and Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma That Has Not Responded to Treatment

Sponsor

Institut Paoli-Calmettes (Other)

Overall Status

Completed

CT.gov ID

NCT00802568

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).

PURPOSE: This phase II trial is studying the side effects of giving fludarabine together with busulfan and antithymocyte globulin followed by donor stem cell transplant and to see how well it works in treating patients with multiple myeloma that has not responded to treatment.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Biological: anti-thymocyte globulin Drug: busulfan Drug: fludarabine phosphate Procedure: allogeneic bone marrow transplantation Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation	Phase 2

Detailed Description

OBJECTIVES:

Primary

To study the toxicity of reduced intensity conditioning comprising fludarabine phosphate, busulfan, and anti-thymocyte globulin followed by allogeneic hematopoietic stem cell transplantation in patients with refractory or relapsed multiple myeloma.

Secondary

To study the tumor response in these patients.
To study the incidence of acute or chronic graft-versus-host disease in these patients.
To study the incidence of infectious complications in these patients.
To study relapse- or progression-free and overall survival of these patients.
To study the biological mechanisms (i.e., taking graft, immunological recovery, antitumor activity, and chimerism).

OUTLINE: This is a multicenter study.

Patients receive reduced intensity conditioning comprising fludarabine IV on days -5 to -1, oral busulfan on days -4 and -3, and anti-thymocyte globulin IV on days -2 and -1. Patients undergo allogeneic hematopoietic stem cell transplantation on day 0.

After completion of study therapy, patients are followed every month for 6 months and then every 3 months for 1½ years.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Non-Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation Following Reduced Intensity Conditioning in Treating Patients With Multiple Myeloma

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

May 1, 2011

Outcome Measures

Primary Outcome Measures

Mortality rate at 1 year []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Diagnosis of multiple myeloma, meeting 1 of the following criteria:
Stage I disease with a bone lesion
Stage II or III disease meeting any of the following criteria:
Elevated beta-2 microglobulin
Deletion of chromosome 13
Refractory or relapsed disease
Presence of an evaluable monoclonal component
Must have achieved reduction of primary tumor after receiving prior intensified chemotherapy with high-dose melphalan and cyclosporine with autologous transplantation
HLA identical family donor available
Bone marrow transplantation is allowed in case hematopoietic stem cell collection fails

PATIENT CHARACTERISTICS:

Karnofsky 70-100%
No contraindications to allogeneic transplantation
No contraindications to drugs used in conditioning regimen
No psychiatric illness
No other cancer within the past 5 years except basal cell skin cancer or epithelioma in situ of the cervix
No serious and uncontrolled infection
Not pregnant or nursing
Fertile patients must use effective contraception