Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Relapsed Multiple Myeloma (REVALLO)
|ClinicalTrials.gov Identifier: NCT01421927|
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : July 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Lenalidomide||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety of a Maintenance Therapy With Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Chemosensitive Relapsed Multiple Myeloma|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Start between Day+100 and Day+120 post-transplant
- Initial dose: 5 mg/day every day
In the absence of thrombocytopenia < 75000/mm3 or neutropenia < 1000/mm3 (with or without G-CSF), increase to the upper level than the ongoing one every third month up to the maximal dose of 15 mg/day every day.
- Safety of lenalidomide [ Time Frame: 1 year ]
The main judgement criteria will be the occurrence of adverse events (AE) requiring the definitive interruption of lenalidomide :
- Grade 3 or 4 adverse event according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 occurring at the lowest dose of lenalidomide or
- Steroid-refractory acute (Seattle criteria) or chronic (National Institutes of Health (NIH) criteria) graft versus host disease or
- Transplant-related death
- One-year Progression-Free Survival [ Time Frame: one year ]Progression defined according to International Myeloma Working Group (IMWG) criteria
- One-year Overall Survival [ Time Frame: one year ]all-cause death
- One-year Transplant Related Mortality [ Time Frame: one year ]
- One-year incidence of Relapse/Progression [ Time Frame: one year ]Progression defined according to IMWG criteria
- Incidences of acute and chronic Graft versus Host Disease [ Time Frame: one year ]Acute graft versus host disease according to Seattle criteria. Chronic graft versus host disease according to NIH criteria.
- Immunophenotypic analysis of blood B, T, NK and dendritic cells [ Time Frame: one year ]
- Chimerism analysis [ Time Frame: one year ]
- safety of lenalidomide [ Time Frame: one year ]all adverse events, graded according to NCI-CTCAE v3
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01421927
|CHU Bordeaux - Hôpital Haut-Lévêque|
|Pessac, France, 33600|
|Principal Investigator:||Stephane Vigouroux, Dr||University Hospital, Bordeaux|
|Study Chair:||Adélaïde DOUSSAU, Dr||University Hospital, Bordeaux|