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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

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
anti-thymocyte globulin
busulfan
fludarabine phosphate
allogeneic bone marrow transplantation
nonmyeloablative allogeneic hematopoietic stem cell transplantation
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma, osteolytic lesions of multiple myeloma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

PRIOR CONCURRENT THERAPY:

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Mortality rate at 1 year

Secondary Outcome Measures

Full Information

First Posted
December 4, 2008
Last Updated
May 13, 2011
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT00802568
Brief Title
Fludarabine, Busulfan, Antithymocyte Globulin, and Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma That Has Not Responded to Treatment
Official Title
Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation Following Reduced Intensity Conditioning in Treating Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma, osteolytic lesions of multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
anti-thymocyte globulin
Intervention Type
Drug
Intervention Name(s)
busulfan
Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate
Intervention Type
Procedure
Intervention Name(s)
allogeneic bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
nonmyeloablative allogeneic hematopoietic stem cell transplantation
Primary Outcome Measure Information:
Title
Mortality rate at 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Blaise, MD
Organizational Affiliation
Institut Paoli-Calmettes
Facility Information:
Facility Name
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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