Chemotherapy + Stem Cell Transplant for Multiple Myeloma
Trial Summary
What is the purpose of this trial?
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy drugs, such as fludarabine phosphate and melphalan, and total marrow irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with fludarabine phosphate and melphalan with or without total marrow irradiation in treating patients undergoing donor peripheral blood stem cell transplant for high-risk stage I or II multiple myeloma.
Research Team
Firoozeh Sahebi, MD
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
This trial is for high-risk stage I or II multiple myeloma patients who have relapsed on new therapies, had a previous stem cell transplant, or have specific genetic changes. They must be able to lie down for about an hour and meet certain health criteria like good heart function and kidney function. People with severe peripheral neuropathy, major medical issues, HIV, active hepatitis B or C, liver cirrhosis, or untreated infections cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preparative Regimen
Patients receive fludarabine phosphate and melphalan, with or without total marrow irradiation, as a preparative regimen for allogeneic hematopoietic stem cell transplant
Transplant
All patients undergo allogeneic peripheral blood stem cell transplant
GVHD Prophylaxis
Patients receive tacrolimus and sirolimus to prevent graft-versus-host disease
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Bortezomib
- Fludarabine Phosphate
- Melphalan
- Peripheral Blood Stem Cell Transplantation
- Total Marrow Irradiation
Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator