Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection
Condition: Myeloma; Lymphoma
MeSH terms: Lymphoma
Intervention: Plerixafor
Intervention description: 240 µg/kg subcutaneous injection on the day that the absolute neutrophil count (ANC) is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.
Intervention MeSH terms: Plerixafor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Myeloma; Lymphoma; Stem cell transplantation

Summary:

      The purpose of this study is to test whether the addition of the drug plerixafor to treatment
      with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the
      chances of transplant. The study will look for the activation of a certain type of blood
      cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The
      investigators will follow the number of patients that achieve the target numbers of CD34+
      cells. The number of patients achieving the target level of CD34+ cells, and the total number
      of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy
      and G-CSF, without plerixafor.

      The investigators will also test the safety of the combination of plerixafor with
      chemotherapy and G-CSF and look at the success of the transplantation after 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-70 years

          2. Multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL) patients in first or second
             complete or partial remission

          3. Eastern Cooperative Oncology Group (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 white blood cells (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 aspartate aminotransferase (AST)/alanine
             aminotransferase (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-hematopoietic progenitor cells (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