Collection of Transplant Stem Cells for Plasma Cell Myeloma
Condition: Plasma Cell Myeloma; Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

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
    

Intervention name(s): Filgrastim; Plerixafor; Apheresis
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days; Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight; 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.
Other intervention name(s): Neupogen; Mozobil
Intervention MeSH terms: Plerixafor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autologous Hematopoietic Cell Transplantation; Plasma Cell Myeloma; Mobilization; Apheresis; Plerixafor