Alteration in Timing of Plerixafor Administration
Condition: Autologous Transplantation
Intervention: Plerixafor
Intervention description: Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses.
Intervention MeSH terms: Plerixafor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Autologous Transplantation

Summary:

      Typically, the collection of blood cells for autologous stem cell transplant is done after
      the drugs granulocyte colony-stimulating factor (G-CSF) and plerixafor have been given to
      activate the bone marrow stem cells to produce a certain type of blood cell, called CD34+
      cells. Currently, plerixafor is given in the evening, about 11 hours before apheresis
      (removal of blood) begins the following morning. The purpose of this study is to test whether
      plerixafor can instead be given 17 hours before apheresis. This timing would be more
      convenient since plerixafor would be given during normal clinic hours, and so patients would
      be within a clinic environment if any side effects develop.

      The study will look for the activation of CD34+ cells in patients who receive plerixafor 17
      hours before apheresis. We will follow the number of patients that achieve the target numbers
      of CD34+ cells, and the total number of CD34+ cells collected. These will be compared to the
      numbers in previous studies giving plerixafor 11 hours before apheresis.

      We will also assess the safety of giving plerixafor 17 hours before apheresis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-70 years

          2. MM patients in first or second complete or partial remission

          3. ECOG performance status of 0 or 1

          4. Up to 3 prior treatment regimens

          5. Meet all eligibility requirements for autologous transplant

          6. Adequate marrow function defined as WBC >3,000; ANC >1,500/mm3 ; Platelets >75,000/mm3

          7. Adequate renal function defined as creatinine clearance > 30 mL/min by Cockcroft-Gault

          8. Adequate liver function defined as AST/ALT/Bilirubin < 2 times upper limit of normal

          9. Able to provide informed consent

         10. Women not pregnant and agree to use contraception

        Exclusion Criteria:

          1. High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary
             artery disease)

          2. Brain metastases or carcinomatous meningitis

          3. Previous treatment with high dose chemotherapy and autologous transplant.

          4. Previous attempt to collect B-HPCs following mobilization with growth factors alone,
             growth factors and chemotherapy, or plerixafor and growth factors.

          5. Acute infection or unexplained fever >38°C

          6. Weight > 175% of ideal body weight as defined by the Devine equation.

          7. Experimental therapy within 4 weeks

          8. Cytokine administration in the previous 14 days