drugset / Trial / NCT01547806

Collection of Transplant Stem Cells for Plasma Cell Myeloma

NCT01547806

Phase 2 Completed 49 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2012-02-22
Primary completion
2014-06-17
Completion
2018-01-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Plerixafor Small molecule
Subject filgrastim Protein / enzyme biologic 10 ug/kg Subcutaneous
Subject filgrastim Protein / enzyme biologic 16 ug/kg Subcutaneous

Indications