Evaluation of the Safety and Efficacy of the Addition of AMD3100 to a G-CSF Mobilization Regimen in Patients With Lymphoma (NHL and HD) and Multiple Myeloma (MM).
Condition: Lymphoma; Non Hodgkin's Lymphoma; Hodgkin's Disease; Multiple Myeloma
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Some patients with multiple myeloma or lymphoma will need treatment with high dose
      chemotherapy to treat their condition. This potent treatment will kill many of the
      blood-forming cells in the bone marrow. The patient will therefore need these blood-forming
      cells replaced after the chemotherapy treatment. This is done by collecting some of teh
      patients own blood-forming stem cells before chemotherapy, storing them and then infusing
      them into the patient after chemotherapy (in the same way as a blood transfusion is given).
      The stem cells will then make their way unto the bone marrow and re-populate it. Having stem
      cells collected and returned later is called an "Autologous Transplant".

      In most patients these blood-forming stem cells (which normally live in the bone marrow) are
      "mobilized" into the blood stream where they are then collected by a process called apheresis
      (a bit like donating blood). This process of mobilization is not always successful. In this
      study patients who did not collect enough stem cells in a previous cell collection attempt to
      have an autologous stem cell transplant will participate. Patients will be mobilized with
      G-CSF (current standard treatment to mobilize stem cells) and the effect of adding AMD3100 to
      G-CSF will be studied by comparing outcomes in patients who get G-CDF with placebo
      (non-active substance which looks like AMD3100) to patients who get G-CSF with AMD3100.

      AMD3100 is a member of a new class of medications called "chemokine inhibitors". The drug
      triggers the movement of stem cells out of the bone marrow into the blood stream. In previous
      studies with healthy volunteers and cancer patients, when AMD3100 and G-CSF were used in
      combination, a greater number of stem cells were mobilized into the blood stream than by
      using g-CSF alone.

      The purposes of this study are to measure how many stem cells can be collected, the number of
      days to collect those cells and the safety of a mobilization regimen of AMD3100 with G-CSF
      compared to G-CSF with placebo. If enough cells are collected to have a transplant, the study
      will also evaluate how well the cells grow when transplanted.
    

Detailed description: 
      This is a multicenter, randomized, comparative, patient-blinded study. Patients with NHL, HD
      or MM who would benefit from an autologous stem cell transplant, who failed previous
      collections or collection attempts with a mobilization regimen of chemotherapy with or
      wihoutG-CSF, and who meet the inclusion/exclusion criteria are eligible to receive
      AMD3100(240µg/kg) or placebo (both given as an evening dose).

      Patients will undergo mobilization with G-CSF (10µg/kg) for 4 consecutive days. On Day 4,
      AMD3100 (240µg/kg) or placebo will be administered in the evening prior to the first
      apheresis and each subsequent evening prior to apheresis thereafter, such that there is a 10
      to 11 hour interval between dosing and the initiation of apheresis. Patients will continue to
      receive G-CSF on each day of apheresis. G-CSF will be administered in the morning and
      approximately 1 hour prior to apheresis. Patients will undergo a minimum of 2 and a maximum
      of 7 aphereses until a minimum of 2x10^6 CD34+ cells/kg or greater than or equal to 5x10^6
      CD34+cells/kg are collected. More cells may be collected, if done within the 7 aphereses.
      Patients who are to receive a tandem transplant will undergo a minimum of 2 and maximum of 7
      aphereses until a minimum of 4x10^6 CD34+ cells/kg are collected. Aphereses should be
      performed on consecutive days (including weekend days)

      The patient will have a peripheral blood (PB) sample collected to measure the number of CD34+
      cell in PB at baseline prior to administration of G-CSF, prior to each administration of
      AMD3100 or placebo and at the initiation of apheresis. In addition, a sample will be obtained
      from each apheresis product to measure the number of CD34+ cells collected in the apheresis
      product.

      Patients who fail to collect greater than or equal to 0.8x10^6 CD34+ cells/kg in 7 aphereses
      will be offered a rescue arm giving AMD3100 plus G-CSF.

      Patients will undergo their ablative chemotherapy before transplantation. Patients will then
      be transplanted. The success of the transplantation will be evaluated. Graft durability will
      be evaluated to 12 months post-transplant. In the event that a sufficient number of cells for
      transplantation are not obtained from the collections, cells may be retained, pooled, and
      transplanted at a later date at the Investigator's discretion.
    

Intervention name(s): Plerixafor (AMD3100); Can be any registered nonpegylated form of G-CSF
Intervention type(s): Drug; Drug
Intervention description(s): 0.24mg/kg SC for 2 to 7 days.; 10mcg/kg SC for 4 days followed by an additional 2 to 7 days.
Intervention MeSH terms: Plerixafor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mobilisation stem cells; G-CSF Mobilisation Regimen; Lymphoma; Multiple Myeloma; Adult patients with lymphoma (Non Hodgkin's Lymphoma, Hodgkin's Disease) or Multiple Myeloma who previously failed Stem Cell Collections or Collection attempts.