Long-term use of lenalidomide and low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: MM-024 Extended Access Program

BMC Cancer
Xin DuJian Hou

Abstract

The efficacy and safety of lenalidomide plus low-dose dexamethasone (Rd) in Chinese patients with relapsed/refractory multiple myeloma (RRMM) was demonstrated in a phase 2, multicenter trial (MM-021). MM-024 was an Extended Access Program (EAP) that allowed responding patients in the MM-021 trial to continue to receive Rd, and to provide additional safety and efficacy data with longer follow-up. Chinese patients with RRMM who completed ≥ 1 year of Rd therapy in MM-021 and who remained progression-free under Rd entered the Treatment Phase of the MM-024 EAP, continuing Rd at the same dose and schedule. Patients in MM-021 who discontinued Rd treatment or progressed were allowed to enroll in the Safety Follow-Up Phase of the MM-024 EAP. Safety data, including the incidence of second primary malignancies (SPMs), were collected for ≥ 5 years from the time the last on-study patient enrolled in the MM-021 trial (primary end point). Efficacy outcomes (time to progression [TTP], progression-free survival [PFS], and overall survival [OS]) were secondary end points. Median follow-up was 38.4 months for the safety population (n = 80) and 43.3 months for the treatment cohort (n = 41). In the safety population, Grade 3-4 adverse events (AEs) ...Continue Reading

References

Nov 23, 2007·The New England Journal of Medicine·Meletios DimopoulosUNKNOWN Multiple Myeloma (010) Study Investigators
Nov 23, 2007·The New England Journal of Medicine·Donna M WeberUNKNOWN Multiple Myeloma (009) Study Investigators
Jun 19, 2010·International Journal of Hematology·Shinsuke IidaTomomitsu Hotta
Jan 15, 2014·Leukemia·S Y KristinssonO Landgren
Sep 4, 2014·The New England Journal of Medicine·Lotfi BenboubkerUNKNOWN FIRST Trial Team

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Citations

Nov 20, 2016·Annals of Oncology : Official Journal of the European Society for Medical Oncology·P MustoUNKNOWN International Myeloma Working Group

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