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
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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
To determine if patients reach a target of ≥ 2x10^6 CD34+ cells/kg within 2 days of apheresis in Non-Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) patients who are proven poor mobilizer.
after last apheresis
Germany: Federal Institute for Drugs and Medical Devices