Multiple Myeloma Clinical Trial
Official title:
A Multicenter, Randomized, Comparative, Patient-blinded Study to Evaluate the Safety and Efficacy of G-CSF Alone Versus AMD3100 (240 µg/kg) Added to a G-CSF Mobilization Regimen in Adult Patients With Non-Hodgkin's Lymphoma (NHL), Hodgkins Disease (HD) or Multiple Myeloma (MM) Who Have Previously Failed Stem Cell Collections or Collection Attempts
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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