Multiple Myeloma Clinical Trial
Official title:
Mobilization and Collection of Autologous Stem Cell for Transplantation (ASCT) for Plasma Cell Myeloma (PCM)
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.
Background:
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, Genzyme) has been recently approved by the Food and
Drug Administration (FDA) for mobilization in PCM. However, the best and most cost effective
strategy for its use remains to be defined.
Objectives:
Evaluate the overall validity of an HPC mobilization strategy (with granulocyte-colony
stimulating factor (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 cluster of
differentiation 34 (CD34) plus cells/kg in a single mobilization cycle.
Collect mobilized Hematopoietic Progenitor Cells by Apheresis (HPC, Apheresis) prior to AHCT
for PCM
Eligibility:
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.
Design:
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 standard
procedure.
The need for an additional mobilizing agent (plerixafor) to be given on day 4 of mobilization
will be evaluated in real time in each patient, based on the peripheral blood CD34 count on
the morning of day 4 of filgrastim administration.
Study accrual over a 3-year period: 70 subjects
;
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