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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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma and Plasma Cell Neoplasm

Intervention: anti-thymocyte globulin (Biological); busulfan (Drug); fludarabine phosphate (Drug); allogeneic bone marrow transplantation (Procedure); nonmyeloablative allogeneic hematopoietic stem cell transplantation (Procedure)

Phase: Phase 2

Status: Completed

Sponsored by: Institut Paoli-Calmettes

Official(s) and/or principal investigator(s):
Didier Blaise, MD, Affiliation: Institut Paoli-Calmettes


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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Mortality rate at 1 year

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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.



- 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


- 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


- See Disease Characteristics

- At least 1 month since participation in another prior clinical trial

Locations and Contacts

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

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: April 2007
Last updated: May 13, 2011

Page last updated: August 20, 2015

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