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

Sponsored by:	Institut Paoli-Calmettes
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00802568

Purpose

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	Intervention	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 II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Bone Marrow Transplantation Cancer Multiple Myeloma

Drug Information available for: Busulfan Fludarabine Fludarabine monophosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
Official Title:	Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation Following Reduced Intensity Conditioning in Treating Patients With Multiple Myeloma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Mortality rate at 1 year [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	April 2007
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802568

Locations

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

Sponsors and Collaborators

Institut Paoli-Calmettes

Investigators

Investigator:

Didier Blaise, MD

Institut Paoli-Calmettes

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received:	December 4, 2008
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00802568 History of Changes
Health Authority:	United States: Federal Government

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

Study placed in the following topic categories:

Antimetabolites
Immunoproliferative Disorders
Immunologic Factors
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Fludarabine monophosphate
Hemostatic Disorders

Immunosuppressive Agents
Multiple Myeloma
Antilymphocyte Serum
Hemorrhagic Disorders
Busulfan
Antineoplastic Agents, Alkylating
Fludarabine
Lymphoproliferative Disorders
Alkylating Agents
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Paraproteinemias
Hemostatic Disorders
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Hematologic Diseases
Vascular Diseases
Fludarabine monophosphate
Immunosuppressive Agents
Pharmacologic Actions
Multiple Myeloma
Antilymphocyte Serum
Neoplasms
Busulfan
Myeloablative Agonists
Fludarabine
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 07, 2009