NCT01547806

Collection of Transplant Stem Cells for Plasma Cell Myeloma

Mobilization and Collection of Autologous Stem Cell for Transplantation (ASCT) for Plasma Cell Myeloma (PCM)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Plasma Cell Myeloma
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Filgrastim	Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
DRUG	Plerixafor	Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
PROCEDURE	Apheresis	The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg.

Timeline

• Start date: 2012-02-22
• Primary completion: 2014-06-17
• Completion: 2018-01-11
• First posted: 2012-03-08
• Last updated: 2018-03-07
• Results posted: 2017-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study