Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide and Planning to Undergo Autologous Stem Cell Transplant
Condition: Multiple Myeloma; Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: plerixafor; filgrastim
Intervention description: Plerixafor 160mg/kg/dose by IV on days 5-8; Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Intervention MeSH terms: Plerixafor; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Rationale: Giving colony-stimulating factors, such as G-CSF and plerixafor helps stem cells
      move from the patient's bone marrow to the blood so they can be collected and stored.
      Purpose: This phase II trial is studying how well plerixafor works in patients with multiple
      myeloma previously treated with lenalidomide and planning to undergo autologous stem cell
      transplant.
    

Eligibility criteria:

        Inclusion - Absolute neutrophil count >= 1000/uL - Platelet >= 75000/uL - Hemoglobin >= 8.0
        g/dL - Serum aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase
        (SGOT), serum alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) and
        total bilirubin < 2 x upper limit of normal (ULN) - Confirmed diagnosis of multiple
        myeloma, requiring therapy - Initial treatment for symptomatic myeloma using a lenalidomide
        based treatment regimen, started =< 12 months prior to registration - Received at least 2
        cycles of treatment with the lenalidomide regimen - Last dose of lenalidomide > 2 weeks
        prior to registration - Eligible to undergo autologous transplantation - ECOG performance
        status (PS) 0 or 1 - Willingness to return for follow-up - Provide informed written consent
        - Adequate cardiopulmonary function: ejection fraction >= 45%, corrected pulmonary
        diffusion capacity of >= 50%, FEV1 >= 50%, FVC >= 50% - Negative serum or urine pregnancy
        test done =< 7 days prior to registration, for women of childbearing potential only
        Exclusion - A co-morbid condition which, in the view of the Investigators, renders the
        patient at high risk from treatment complications - Active malignancy with the exception of
        non melanoma skin cancer or in situ cervical or breast cancer - Other co-morbidity which
        would interfere with patient's ability to participate in the trial, e.g. uncontrolled
        infection, uncompensated heart or lung disease - Other concurrent chemotherapy,
        radiotherapy, or any ancillary therapy considered investigational - Use of cyclophosphamide
        as part of stem cell mobilization - Use of more than one regimen for treatment of
        symptomatic myeloma - Dialysis dependent renal failure - Pregnant women or women of
        reproductive ability who are unwilling to use effective contraception - Nursing women - Men
        who are unwilling to use a condom (even if they have undergone a prior vasectomy) while
        having intercourse with any woman, while taking the drug and for 4 weeks after stopping
        treatment - Acute infection, active HIV infection