At a glance
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Mobilization and Collection of Autologous Stem Cell for Transplantation (ASCT) for Plasma Cell Myeloma (PCM)
In Brief
A Phase 2 clinical trial evaluating Filgrastim, Plerixafor, and 1 other intervention for Plasma Cell Myeloma and Multiple Myeloma. Completed, enrolled 49 participants across 1 site.
Detailed Summary
Background: \- One beneficial treatment for plasma cell myeloma is high-dose chemotherapy followed by stem cell transplant. Researchers want to collect stem cells from the blood for later transplant. Objectives: \- To collect stem cells for transplant as part of treatment for plasma cell myeloma. Eligibility: \- Individuals at least 18 years of age who will have chemotherapy and stem cell transplant for plasma cell myeloma. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * Participants will have filgrastim injections for 5 days before collection. This will move stem cells from the bone marrow to the blood. * Participants will have apheresis to collect the stem cells. * Participants who need additional apheresis procedures to collect stem cells will have filgrastim and a dose of plerixafor to improve the collection yield.
Study Details
Timeline
Interventions
Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg.