At a glance
ClinicalIndex Comparison Record- ✓Multiple myeloma, early Stage II-III or relapsed/progression after initial treatment of Stage I disease
- ✓Patient has HLA-identical sibling donor
- ✓Age ≤ 70 years
- ✓Karnofsky performance status > 70%
- ✕Smoldering multiple myeloma, monoclonal gammopathy of unknown significance, or primary amyloidosis
- ✕Prior allogeneic hematopoietic cell transplantation
- ✕Severe psychological or medical illness
- ✕Pregnant or lactating
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma
In Brief
A Phase 2 clinical trial evaluating Autologous hematopoietic cell transplant (Auto-HCT), Allogeneic hematopoietic cell transplant (Allo-HCT), and 6 other interventions for Blood Cancer and Multiple Myeloma. Completed, enrolled 63 participants across 1 site.
Detailed Summary
Mixed chimerism transplantation is an approach to allogeneic transplants that attempts to decrease regimen-related toxicity by using non-myeloablative preparatory regimens; establish mixed chimerism using low dose total body irradiation along with immunosuppression using cyclosporine and mycophenolate mofetil; suppress graft-vs-host and host-vs-graft reactions to allow a mixed chimeric state to be established, encourage tolerance and prevent graft-vs-host disease (GvHD) during the mixed chimerism period and use donor lymphocyte infusions to convert the patient to a full chimera while developing a graft-vs-tumor effect.
Study Details
Timeline
Interventions
The target cell dose is 2.6 x 10e6 CD34+ cells/kg
The target cell dose is 5 x 10e6 CD34 cells/kg
Cyclophosphamide administered intravenously (IV) at 4 mg /m² mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion
* Filgrastim 10 µg/kg/day to mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion (Auto-HCT) * Filgrastim 5 µg/kg/day starting 6 days after melphalan (Day 4 after Auto-HCT) * Filgrastim 16 µg/kg/day to mobilize donor peripheral blood progenitor cells (PBPC) for allogeneic transplant (Allo-HCT)
Melphalan 200 mg/m2 (high-dose) intravenously as conditioning for Auto-HCT
200 centigray (cGy) total body irradiation delivered on Day 0
Cyclosporine administered twice-daily by mouth at a dose of 6.25 mg/kg from Day -3 through Day 56
Mycophenolate mofetil will begin at 15 mg/kg twice-daily by mouth from Day 0 to Day 27