Collection of Transplant Stem Cells for Plasma Cell Myeloma
Condition: Plasma Cell Myeloma; Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Filgrastim; Plerixafor; Apheresis
Intervention description: 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.
Intervention MeSH terms: Plerixafor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Autologous Hematopoietic Cell Transplantation; Plasma Cell Myeloma; Mobilization; Apheresis; Plerixafor

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.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        Multiple Myeloma Criteria:

        Subjects with an indication for autologous hematopoietic cell transplant (AHCT) for the
        treatment of PCM as determined by the principal investigator (PI) or lead associate
        investigator (LAI).

          -  Subjects following induction treatment for plasma cell myeloma (PCM)

          -  Subjects with recurrent or persistent evaluable disease who have not undergone AHCT
             for the treatment of the PCM.

        Other Eligibility Criteria:

        Age greater than or equal to 18 years and less than or equal to 75 years. In subjects
        between 65 and 75 years of age, physiologic age and co-morbidity will be thoroughly
        evaluated before enrolling.

        Karnofsky performance status of 70% or greater (Eastern Cooperative Oncology Group ((ECOG)
        0 or 1)

        Ejection fraction (EF) by multigated acquisition scan (MUGA) or 2-D echocardiogram within
        institution normal limits. In case of low ejection fraction (EF), the subject may remain
        eligible after a stress echocardiogram is performed if the EF is more than 35% and if the
        increase in EF with stress is estimated at 10% or more.

        Hemoglobin (Hgb) greater than or equal to 8 g/dl (transfusion acceptable)

        No history of abnormal bleeding tendency.

        Patients must be able to give informed consent

        EXCLUSION CRITERIA:

        Prior allogeneic stem cell transplantation

        Hypertension not adequately controlled by 3 or less medications.

        Clinically significant cardiac pathology: myocardial infarction within 6 months prior to
        enrollment, Class III or IV heart failure according to New York Heart Association (NYHA),
        uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic
        evidence of acute ischemia or active conduction system abnormalities. Specifically, any
        history of cardio-vascular pathology or symptoms, not clearly fitting this exclusion
        criterion will prompt an evaluation by a Clinical Center Cardiologist and eligibility will
        be considered on a case-by-case basis. Should the cardiologist deem the patients findings
        on work-up to be not clinically significant pathology, the patient will have met this
        exclusion criterion.

        Patients with a history of coronary artery bypass grafting or angioplasty will receive a
        cardiology evaluation and be considered on a case-by-case basis.

        Active hepatitis B or C infection

        Human immunodeficiency virus (HIV) seropositive, with positive confirmatory nucleic acid
        test

        Patients known or found to be pregnant.

        Patients of childbearing age who are unwilling to practice contraception.

        Patients may be excluded at the discretion of the principal investigator (PI)/lead
        associate investigator (LAI) if it is deemed that allowing participation would represent an
        unacceptable medical or psychiatric risk.