Multiple Myeloma Clinical Trial
Official title:
Safety of a Maintenance Therapy With Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Chemosensitive Relapsed Multiple Myeloma
Allogeneic stem cell transplantation (Allo-SCT) in multiple myeloma (MM) remains a controversial topic because of a high risk of relapse and a significant transplant-related mortality (TRM). In an effort to reduce the TRM, most allogeneic transplants in MM are now performed after reduced-intensity conditioning regimens. In these conditions, TRM usually range from 10 to 20%. However, reducing the intensity of the conditioning invariably increases the incidence of relapse to 45 to 60%. As a consequence, post-transplant strategies to reduce the incidence of relapse after reduced-intensity Allo-SCT should be considered and evaluated.
Lenalidomide has a significant clinical activity in patients with relapsed or refractory MM
and in patients relapsing after Allo-SCT. The mechanisms of action involve immunomodulation,
anti-angiogenesis activity, direct anti tumor activity and effects on microenvironment. So
far, the experience with lenalidomide after Allo-SCT has been limited to patients with
progressive disease. In such patients, some responses are observed but most of them are
transient with median progression-free survivals of less than one year. Lenalidomide used as
maintenance therapy in patients with persistent rather than progressive disease might be a
better approach.
Lenalidomide is interesting in the Allo-SCT setting also because some recent studies
focusing on its immunological properties have suggested that the molecule could stimulate
the graft versus myeloma effect. First, it has been demonstrated in vitro that lenalidomide
can inhibit the proliferation and the suppressor function of regulatory T cells. Secondly, a
clinical study using lenalidomide as salvage therapy after Allo-SCT demonstrated an increase
of activated T cells and NK cells. Finally, a case report described a patient's response to
lenalidomide associated with the development of an acute graft versus host disease.
Taken together, these data suggest that patients with MM who have a persistent disease after
a reduced-intensity Allo-SCT might benefit from a post-transplant maintenance strategy with
lenalidomide by a direct anti-tumor effect and a stimulation of the graft versus myeloma
effect. The primary objective of this study is to evaluate the safety of such a strategy.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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