Pomalidomide/Cyclophosphamide/Dexamethasone in Relapse Refractory Myeloma: Safety Profile in Mexicans
Status:
Unknown status
Trial end date:
2020-07-30
Target enrollment:
Participant gender:
Summary
Despite available therapies, MM uniformly fatal and participants who have received prior
lenalidomide (Len) and bortezomib have a median overall survival (OS) of 9 months.
Pomalidomide (Pom) plus low-dose dexamethasone (Dex) significantly improved efficacy
parameters in terms of progression free survival (PFS), OS, and overall response (ORR)
compared with high-dose Dex in participants with refractory or relapsed, and refractory MM,
including participants with disease refractory to both bortezomib and lenalidomide.
Alkylating agents also represent standard therapies for participants with MM. There are some
reports demonstrating combination of Len and continuous cyclophosphamide (Cy) achieve an ORR
of 50% in Len refractory participants, suggesting Cy may be able to overcome resistance to
Len.
The investigators aimed to assess the safety in Mexican MM participants in relapse/refractory
stage of the triple combination: IV Cy in combination with Pom plus Dex until disease
progression. A multicenter study is proposed.
Primary endpoint: Safety. Efficacy as secondary endpoint: PF, OS and ORR.
Phase:
Phase 2
Details
Lead Sponsor:
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado