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

May 13, 2011 updated by: Institut Paoli-Calmettes

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13273
        • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mortality rate at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Investigators

  • Didier Blaise, MD, Institut Paoli-Calmettes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

December 4, 2008

First Submitted That Met QC Criteria

December 4, 2008

First Posted (Estimate)

December 5, 2008

Study Record Updates

Last Update Posted (Estimate)

May 16, 2011

Last Update Submitted That Met QC Criteria

May 13, 2011

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000626720
  • IPC-2005-002
  • IPC-ITT 04-02
  • EUDRACT-2005-01053-13
  • INCA-RECF0428
  • AMGEN-IPC-2005-002
  • JANSSEN-IPC-2005-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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