Multiple Myeloma Clinical Trial
Official title:
Induction and Consolidation With Elotuzumab Before and After Peripheral Stem Cell Autologous Graft in Elderly Patients With Multiple Myeloma
This is a multicenter, open-label phase II study, assessing the efficacy of elotuzumab in elderly patients with multiple myeloma undergoing peripheral stem cell autologous graft
In patients of 65 years of age or older, intensive treatment (TI) with hematopoietic stem
cell autologous graft (ASCH) is not considered as the gold standard. Nowadays, given the rise
of new treatments, new studies assessing TI with ASCH in elderly, seem required. The
association bortezomib (VEL) - thalidomide (THAL) - dexamethasone (DEX) is considered as the
standard induction (Kumar, Flinn et al. 2012, Ludwig, Viterbo et al. 2013). However, more and
more strategies with immunotherapies are developed. Furthermore, it looks encouraging to use
several monoclonal antibodies at different clinical development levels. Thus, elotuzumab
(ELO) is an IgG1 (immunoglobulin gamma-1) (IgGκ) humanized monoclonal antibody directed
against SLAMF7. SLAMF7 is a glycoprotein expressed by myeloma cells and natural killer (NK)
but not by healthy tissues. Consequently, elotuzumab can kill specifically myeloma cells
without affecting healthy tissues (Hsi, Steinle et al. 2008). A phase I study assessed the
safety of ELO in association with VEL, REV (Lenalidomide) and DEX in induction first-line
treatment in elderly patients with median age of 67 years (Usmani, Sexton et al. 2015). There
were no significant increase of side effects with this association compared with side effects
usually reported with VEL, REV and DEX. Thus, adding ELO could lead to an increase of
response rate, with no increase of toxicity.
For more than 10 years, the standard intensive treatment associates a MEL (MELPHALAN)
conditioning (200 mg/m2) with a blood graft. In a recent study, almost all patients aged
between 65-69 and 70-74 years received MEL at 200 mg/m2. The adverse events rate was similar
between the different ages and a very low non-tied relapse mortality. Thus, in elderly
patients selected, the use of MEL at 200 mg/m2 seems sure.
Moreover, it's widely admitted that the conditioning treatment should be based on an
efficient drugs association with a limited toxicity. Studies assessing consolidation
treatment with an association of new drugs are limited. Initial results suggest that the use
of new drugs after intensive treatment (IT) with ASCH should increase response rate and
improve progression-free survival and global survival.
The aim of this study IFM 2016-03 is to assess intensive treatment (IT) with AHSCT
(Autologous hematopoietic stem cell transplantation) in elderly and to associate the
different steps (induction, high dose conditioning, consolidation) with immunotherapy. Given
the prior results of IFM and international studies, a VGPR (Very Good Partial Response) rate
of around 85% is expected.
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