To assess the efficacy and toxicity of plerixafor (AMD 3100) together with granulocyte-colony stimulating factor (G-CSF) for stem cell mobilisation, in patients with myeloma or lymphoma requiring high dose chemotherapy with stem cell rescue.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
G-CSF will be given daily from day 1, which will usually be timed to fall toward the end of the working week. Plerixafor will commence on day 4 at as near to 10 PM as practicable, and also on day 5 and subsequent days (maximum of 4 total days) at a similar time of day if insufficient CD34+ cells have been collected. Stem cell harvesting will be carried out on day 5 and if necessary on days 6, 7 and 8, until the target yield of 4 x 106 CD34+ cells /kg recipient weight have been achieved. The daily dose of G-CSF is 300 ug for patients up to and including 60kg in weight; 480 ug for patients over 60 kg but under 96 kg, and 600 ug for patients weighing 96 kg or more. This equates to a dose of at least 5 ug/kg (maximum 8 mg/kg) for all patients up to 120 kg. The daily dose of plerixafor is 240 ug/kg if the creatinine clearance is equal to or greater than 50mls/minute; if less than this then the dose is 160 ug/kg daily.
Dept of Haematology, University of Liverpool
Liverpool, Merseyside, United Kingdom
A composite primary endpoint of BOTH an adequate stem cell harvest (≥4 x 106 CD34+/kg in no more than 2 aphereses); AND a neutrophil count that never falls below 1.0 x 109 / Litre in the 3 weeks following initiation of mobilisation.
Time frame: 3 weeks following initiation of mobilisation
Serial neutrophil and platelet counts during mobilisation
Time frame: 1 Day
Total stem cell yield in 1-2 aphereses
Time frame: 1 day
The usage of plerixafor and the number and timing of apheresis collections
Time frame: 1 day
The time to neutrophil engraftment after subsequent transplantation
Time frame: First of 2 consecutive days on which the neutrophil count equals or exceeds 0.5 x 109/litre
The time to platelet engraftment after subsequent transplantation
Time frame: First of two consecutive days on which the platelet count equals or exceeds 50 x 109/litre, having been free of platelet transfusion for at least 48 hours
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