Abstract
Background. Pomalidomide in association with dexamethasone is approved for RRMM in 3rd line and beyond based on the multicenter international phase 3MM-003 study that demonstrated greater efficacy for Pomalidomide plus dexamethasone over high dose dexamethasone. However, MM-003 mainly recruited RRMM with 5 prior lines +, and very few data are available regarding real life Pomalidomide-based treatment in 3rd and 4th line RRMM.
The aim of this study was to study efficacy and safety of Pomalidomide-based treatment in 3rd and 4th line RRMM.
Methods. This study is a retrospective, multicenter study based on 101 consecutive RRMM treated with Pomalidomide-based treatment in 3rd and 4th line. All assessment made according to IMWG.
Results. The median age was 62.5 (range, 30-86), with 36% older than 65 years, sex ratio M/F 1.25 and ISS disease stage 2 or 3 in 58%. 100% patients received previous treatment with Bortezomib and Lenalidomide. 52 patients (48%) had pomalidomide-based therapy as 3rd, and 56 (52%) as 4th line. 74% of patients received a double-based therapy (Pomalidomide plus Dexamethasone) and 26% received a triple based therapy (Pomalidomide, Cyclophosphamide and Dexamethasone).
Overall ORR was 90%, with 40% ≥VGPR and 17% CR with Pomalidomide-based as 3rd line and 52%, 16% and 3.5%, respectively, for Pomalidomide-based as 4th line. The rate of relapse and death was respectively 58% and 48% in third line and 74% and 50% in fourth line of treatment. Manque TTP et OS / follow up
22% of patients have discontinued treatment, because of adverse events including hematological events (40% of patients) and non hematological events (12% of patients). The most common adverse events grade 3 or 4 were neutropenia (22%), anemia (11%), thrombocytopenia (7%) and infectious disease (5%). Adverse events resulted in a reduction of Pomalidomide dose in 30% of patients. No patient died related to adverse events.
Conclusion. Pomalidomide used after the second relapse and in a triple association is more effective for treatment of RRMM patients. Further prospective studies are warranted to confirm this data on a larger MM population.
Leleu: AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Pierre Fabre: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Merck: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees.
Author notes
Asterisk with author names denotes non-ASH members.
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