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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00802568
Recruitment Status : Completed
First Posted : December 5, 2008
Last Update Posted : May 16, 2011
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2007
Actual Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma




Primary Outcome Measures :
  1. Mortality rate at 1 year


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802568


Locations
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France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
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OverallOfficial: Didier Blaise, MD Institut Paoli-Calmettes

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ClinicalTrials.gov Identifier: NCT00802568     History of Changes
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
First Posted: December 5, 2008    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: December 2008

Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma
osteolytic lesions of multiple myeloma

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Fludarabine
Fludarabine phosphate
Busulfan
Antilymphocyte Serum
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Alkylating Agents
Antineoplastic Agents, Alkylating
Myeloablative Agonists