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
Oct 18, 2002·Blood·Paul G RichardsonKenneth C Anderson
Nov 3, 2007·Blood·Shaji K KumarMorie A Gertz
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
Jul 25, 2009·Leukemia·M A DimopoulosD M Weber
Oct 27, 2009·The Lancet Oncology·S Vincent RajkumarUNKNOWN Eastern Cooperative Oncology Group
Jun 19, 2010·International Journal of Hematology·Shinsuke IidaTomomitsu Hotta
Oct 5, 2011·The Oncologist·Dianne PulteHermann Brenner
Feb 11, 2012·Blood·Meletios A DimopoulosGareth J Morgan
Jun 21, 2013·Journal of Hematology & Oncology·Jian HouJianmin Wang
Aug 8, 2013·Cancer·Guillemette FouquetXavier Leleu
Jan 15, 2014·Leukemia·S Y KristinssonO Landgren
Feb 15, 2014·The Lancet Oncology·Antonio PalumboPhilip L McCarthy
Jul 1, 2014·Annals of Hematology·Manola ZagoKatja Weisel
Sep 4, 2014·The New England Journal of Medicine·Lotfi BenboubkerUNKNOWN FIRST Trial Team
Nov 11, 2014·Blood Cancer Journal·M A DimopoulosR Baz