Melphalan and Stem Cell Transplant Before Total-Body Irradiation and Donor Stem Cell Transplant in Treating Patients With Stage I-III Multiple Myeloma
NCT00003954 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2020-02-06
Summary
In this study donor bone marrow transplantation is divided into a two step process to try to significantly reduce the side effects of the procedure yet still provide patients with multiple myeloma the benefits of this procedure
Conditions
- Refractory Multiple Myeloma
- Stage I Multiple Myeloma
- Stage II Multiple Myeloma
- Stage III Multiple Myeloma
Interventions
- DRUG
-
melphalan
Given IV
- PROCEDURE
-
autologous hematopoietic stem cell transplantation
Undergo autologous bone marrow or PBSCT
- PROCEDURE
-
autologous bone marrow transplantation
Undergo autologous bone marrow or PBSCT
- PROCEDURE
-
peripheral blood stem cell transplantation
Undergo autologous bone marrow or PBSCT
- RADIATION
-
total-body irradiation
Undergo TBI
- PROCEDURE
-
peripheral blood stem cell transplantation
Undergo donor PBSCT
- DRUG
-
cyclosporine
Given IV and PO
- DRUG
-
mycophenolate mofetil
Given PO
- BIOLOGICAL
-
therapeutic allogeneic lymphocytes
Undergo DLI
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Fred Hutchinson Cancer Center
lead OTHER
Principal Investigators
-
David Maloney · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1999-03-31
- Primary Completion
- 2002-12-31
Countries
- United States
- Italy
Study Locations
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