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Tandem Autologous HCT/Nonmyeloablative Allogeneic HCT From HLA-Matched Related and Unrelated Donors Followed by Bortezomib Maintenance Therapy for Patients With High-Risk Multiple Myeloma
This phase II trial studies the side-effects and anti-cancer effects of giving an autologous or syngeneic stem cell transplant followed by an allogeneic donor stem cell transplant and bortezomib. Patients treated on this trial have newly diagnosed high-risk, relapsed, or refractory multiple myeloma (MM). Giving chemotherapy before an autologous stem cell transplant slows or stops the growth of cancer cells by preventing them from dividing or killing them. Stem cells that were harvested earlier from the patient's blood and frozen are then returned to the patient to replace the blood-forming cells that were destroyed by chemotherapy. Giving chemotherapy and total-body irradiation before an allogeneic donor stem cell transplant also prevents the patient's immune system from rejecting the donor's stem cells. Undergoing an autologous or syngeneic stem cell transplantation followed by an allogeneic donor stem cell transplant and bortezomib may be overall more effective in killing cancer cells.
Details
| Lead sponsor | Fred Hutchinson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 32 |
| Start date | 2008-10 |
| Completion | 2016-10 |
Conditions
- Refractory Plasma Cell Myeloma
Interventions
- Autologous Hematopoietic Stem Cell Transplantation
- Bortezomib
- Cyclosporine
- Cyclosporine
- Fludarabine Phosphate
- Laboratory Biomarker Analysis
- Melphalan
- Mycophenolate Mofetil
- Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
- Peripheral Blood Stem Cell Transplantation
Primary outcomes
- Number of Patients Surviving Progression-free — At 2 years after the autograft
Number of subjects surviving without progressive disease post-transplant. Progressive disease criteria: 1. Greater than 25% increase in serum (absolute increase must be ≥0.5 g/dL) or urine (absolute increase must be ≥200 mg/24h) M proteins compared to best response status after autologous transplant. 2. Appearance of new lytic bone lesions or plasmacytomas.
Countries
United States