IKEMA: Interim Analysis of A Phase III, Randomized, Open-Label Study скачать в хорошем качестве

IKEMA: Interim Analysis of A Phase III, Randomized, Open-Label Study

Isatuximab Plus Carfilzomib and Dexamethasone Vs Carfilzomib and Dexamethasone In Relapsed/Refractory Multiple Myeloma (IKEMA): Interim Analysis of A Phase III, Randomized, Open-Label Study In this Phase III study, pts with RRMM and 1-3 prior lines of therapy were randomized 3:2 and stratified by number of prior lines and R-ISS to receive Isa-Kd or Kd. Isa-Kd arm received Isa (10mg/kg IV) weekly for 4 weeks, then every 2 weeks. Both arms received K (20mg/m2 days 1-2, 56mg/m2 thereafter) twice-weekly for 3 of 4 weeks, and d (20mg) twice-weekly. Treatment continued until disease progression or unacceptable adverse events (AE). Primary objective: demonstrate an increase in PFS of Isa-Kd vs Kd, determined by an Independent Response Committee (IRC). Comparison between arms conducted through log-rank testing. Key secondary objectives: evaluation of overall response rate (ORR), rate of very good partial response (VGPR) or better, complete response (CR) rate, MRD negativity rate (10^5 by NGS), and overall survival (OS). Key secondary endpoints tested with a closed test procedure. Safety data included treatment emergent adverse events (TEAE), and hematology and biochemistry results for all pts. Interim efficacy analysis was planned when 65% of the total expected PFS events were observed. Addition of Isa to Kd provided a superior, statistically significant improvement in PFS with clinically meaningful improvement in depth of response. Isa-Kd was well tolerated with manageable safety and a favorable benefit-risk profile, and represents a possible new standard of care treatment in pts with relapsed MM. Please subscribe to our channel! Subscribe to International Myeloma Foundation: http://bit.ly/XlUtPE Visit our website at: https://www.myeloma.org Find us online: Facebook:   / myeloma   Google+: http://gplus.to/imfmyeloma IMF on twitter: @IMFMyeloma (  / imfmyeloma  ) Dr. Durie on twitter: @BrianDurieMD (  / brianduriemd  ) Support the IMF! http://bit.ly/WskQHC Category Nonprofits & Activism License Standard YouTube License