Collection of Transplant Stem Cells for Plasma Cell Myeloma
- 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.
- To collect stem cells for transplant as part of treatment for plasma cell myeloma.
- Individuals at least 18 years of age who will have chemotherapy and stem cell transplant for plasma cell myeloma.
- 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.
Plasma Cell Myeloma
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Mobilization and Collection of Autologous Stem Cell for Transplantation (ASCT) for Plasma Cell Myeloma (PCM)|
- 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...
- Determine the proportion of subjects requiring addition of plerixafor to the G-CSF mobilization the proportion of subjects achieving the target or optimum goal of greater than or equal to 5 times 10(6) CD34 plus cells/kg in a single mobilization...
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
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 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 for PCM
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547806
|Contact: Daniel H Fowler, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|Principal Investigator:||Daniel H Fowler, M.D.||National Cancer Institute (NCI)|