Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation Following Reduced Intensity Conditioning in Treating Patients With Multiple Myeloma
18 Years
65 Years
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation Following Reduced Intensity Conditioning in Treating Patients With Multiple Myeloma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Mortality rate at 1 year
Safety Issue:
No
Principal Investigator
Didier Blaise, MD
Investigator Affiliation:
Institut Paoli-Calmettes
Authority:
United States: Federal Government
Study ID:
CDR0000626720
NCT ID:
NCT00802568
Start Date:
April 2007
Completion Date:
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- refractory multiple myeloma
- osteolytic lesions of multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
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