Mobilization and Collection of Autologous Stem Cell for Transplantation (ASCT) for Plasma Cell Myeloma (PCM)
High-dose chemotherapy followed by autologous hematopoietic cell transplant (AHCT) remains a
critical part of the Plasma Cell Myeloma (PCM) treatment in subjects eligible for the
procedure. The timing of the procedure however, has become more controversial recently. This
protocol will allow collection of Hematopoietic Progenitor Cells by Apheresis (HPC,
Apheresis) in potential candidates for various PCM protocols at the Clinical Center.
The mobilizing agent plerixafor (Mozobil(Registered Trademark), Genzyme) has been recently
approved by the FDA for mobilization in PCM. However, the best and most cost effective
strategy for its use remains to be defined.
Evaluate the overall validity of an HPC mobilization strategy (with G-CSF alone or in
combination with plerixafor) using a formula calculating the likelihood of collecting
greater than or equal to 5 time 10(6) CD34 plus cells/kg in a single mobilization cycle.
Collect mobilized Hematopoietic Progenitor Cells by Apheresis (HPC, Apheresis) prior to AHCT
Subjects with a possible indication for AHCT for the treatment of newly diagnosed PCM.
Subjects with recurrent or persistent evaluable disease who have not undergone AHCT for the
treatment of the PCM.
Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in
various clinical protocols.
Mobilization will be provided by a 5-daily administration of filgrastim according to
The need for an additional mobilizing agent (plerixafor) to be given on day 5 of
mobilization will be evaluated in real time in each patient, based on the peripheral blood
CD34 count on the morning of day 5 of filgrastim administration.
Study accrual over a 3-year period: 70 subjects
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the overall validity of an HPC mobilization strategy (with G-CSF alone or in combination with plerixafor) using a formula calculating the likelihood of collecting greater than or equal to 5 times 10(6) CD34 plus cells/kg in a single mob...
Claude Sportes, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|