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

NCT ID: NCT00802568

Last Updated: 2011-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30

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.

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

anti-thymocyte globulin

Intervention Type: BIOLOGICAL

busulfan

Intervention Type: DRUG

fludarabine phosphate

Intervention Type: DRUG

allogeneic bone marrow transplantation

Intervention Type: PROCEDURE

nonmyeloablative allogeneic hematopoietic stem cell transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 1 month since participation in another prior clinical trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Principal Investigators

Didier Blaise, MD

Role:

Institut Paoli-Calmettes

Locations

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, , France

Countries

France

Other Identifiers

IPC-2005-002

Identifier Type: -

Identifier Source: secondary_id

IPC-ITT 04-02

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2005-01053-13

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0428

Identifier Type: -

Identifier Source: secondary_id

AMGEN-IPC-2005-002

Identifier Type: -

Identifier Source: secondary_id

JANSSEN-IPC-2005-002

Identifier Type: -

Identifier Source: secondary_id

CDR0000626720

Identifier Type: -

Identifier Source: org_study_id