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Bortezomib, Thalidomide, and Dexamethasone After Melphalan and Stem Cell Transplant in Treating Patients With Stage I-III Multiple Myeloma
Sponsor: City of Hope Medical Center
Summary
RATIONALE: Bortezomib and thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Bortezomib may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with thalidomide and dexamethasone may kill any cancer cells that remain after high-dose melphalan and stem cell transplant in patients with multiple myeloma. PURPOSE: This phase II trial is studying the side effects of giving bortezomib together with thalidomide and dexamethasone after melphalan and stem cell transplant and to see how well it works in treating patients with stage I-III multiple myeloma.
Official title: A Phase II Study of Maintenance Treatment With Sequential Bortezomib, Thalidomide and Dexamethasone Following Autologous Peripheral Blood Stem Cell Transplant in Patients With Multiple Myeloma
Key Details
Gender
All
Age Range
Any - 70 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2008-03-08
Completion Date
2014-04-21
Last Updated
2026-11-02
Healthy Volunteers
No
Interventions
bortezomib
Given IV
dexamethasone
Given orally
melphalan
Given IV
thalidomide
Given orally
cytogenetic analysis
Performed on baseline and post transplant bone marrow specimens
fluorescence in situ hybridization
Performed on baseline and post transplant bone marrow specimens
laboratory biomarker analysis
Baseline, post transplant and prior to start of bortezomib, every 3 months post transplant for the first year, after 6 cycles of bortezomib, every year after transplant for 2-4 years.
questionnaire administration
Completed at baseline (within 6 weeks prior to enrollment) and at 2 months post transplant and once a month after that for the first year. For the second year the questionnaire will be completed every 3 months as long as on thalidomide for the duration of the study.
autologous hematopoietic stem cell transplantation
Minimum dose of 2 X 10(6) CD34 + cells/kg day 0 after two days of treatment with Melphalan
peripheral blood stem cell transplantation
Minimum dose of 2 X 10(6) CD34 + cells/kg day 0 after two days of treatment with Melphalan
Locations (1)
City of Hope Medical Center
Duarte, California, United States