Multiple Myeloma Clinical Trial
Official title:
Safety and Efficacy of Stem Cell Mobilization Using G-CSF (Filgrastim) Alone Compared to Intermediate-dose Cytosine Arabinoside Plus G-CSF in Multiple Myeloma Patients.
The purpose of the study is to compare safety and efficacy of stem cell mobilization using G-CSF (filgrastim) alone vs. intermediate-dose cytosine arabinoside plus G-CSF in multiple myeloma patients.
Autologous hematopoietic stem cell transplantation (autoHSCT) is a standard treatment of
eligible patients suffering from multiple myeloma (MM). Tandem autoHSCT allows to further
improve results of the therapy. Nowadays, 99% of the procedures are performed using
peripheral blood as a source of stem cells. Hence, the crucial point is to harvest adequate
number of stem cells allowing hematopoietic recovery. The number of 5 × 10^6 CD34+ cells/kg
is considered the optimal level, as far as double autoHSCT is concerned. There are two main
mobilization strategies being used: based on G-CSF alone or in combination with chemotherapy
(cyclophosphamide (CY) at dose range 1.5-7 g/m2 is mainly used in MM setting). However, a
proportion of patients (5-40%) fail to collect the minimum number of cells required. Novel
agents, like plerixafor, CXCR4 inhibitor, may enable effective CD34+ cell harvest in "poor
mobilizers". Nevertheless, the optimal first-line and cost-effective protocol for
mobilization of hematopoietic stem cells has not been determined so far.
Randomized trials comparing chemomobilization with use of CY + G-CSF to G-CSF alone, which
had been conducted so far, did not demonstrate clear advantage of addition of CY to growth
factor. Intermediate-dose cytosine arabinoside (AraC), 1.6 g/m2 plus filgrastim, has been
shown to produce very high efficacy as a first or second-line mobilization regimen in
patients with lymphoid malignancies, including MM. In a retrospective comparison, this
strategy was significantly more effective than CY + filgrastim. This suggest that the type of
chemotherapy agent added to G-CSF may play role in mobilization efficacy and that the
combination of AraC and G-CSF may be more effective than G-CSF used alone. The goal of
current study is to verify this hypothesis in randomized controlled trial.
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