Clinical Trial: Collection of Transplant Stem Cells for Plasma Cell Myeloma
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Mobilization and Collection of Autologous Stem Cell for Transplantation (ASCT) for Plasma Cell Myeloma (PCM)
Brief 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.
Detailed Summary:
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 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 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
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
Sponsor: National Cancer Institute (NCI)
Current Primary Outcome: Evaluate overall validity of Hematopoietic Progenitor Cells by apheresis [ Time Frame: 8 days ]
Original Primary Outcome: 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...
Current Secondary Outcome:
Original Secondary Outcome: 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...
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: March 6, 2012
Date Started: February 22, 2012
Date Completion: December 1, 2017
Last Updated: April 13, 2017
Last Verified: September 27, 2016
