In this episode, we dive into updates in Minimal Residual Disease (MRD) in multiple myeloma, along with the FDA ODAC meeting in April 2024 to decide on MRD as a surrogate endpoint for accelerated approval. Our guests are Dr. Benjamin Derman and Dr. Manni Mohyuddin. Here are the key papers we discussed:1. Recording of FDA ODAC meeting: https://www.youtube.com/watch?v=pooME9gMaL02. EVIDENCE meta-analysis on individual-level and trial-level correlation between MRD and PFS/OS in multiple myeloma: https://pubmed.ncbi.nlm.nih.gov/38768337/3. Predictors of un-sustained MRD-negativity in multiple myeloma: a) Secondary analysis of FORTE trial: https://pubmed.ncbi.nlm.nih.gov/38048557/b) Secondary analysis of GEM2012MENOS65 and GEM2014MAIN trials: https://pubmed.ncbi.nlm.nih.gov/38048552/4. Kinetics of MRD resurgence and subsequent relapse in multiple myeloma: https://pubmed.ncbi.nlm.nih.gov/34807986/5. MRD2STOP trial (MRD-guided maintenance discontinuation): https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.1066. MRD-guided maintenance discontinuation in myeloma (Secondary analysis of GEM2012MENOS65 trial): https://pubmed.ncbi.nlm.nih.gov/37506339/

Ask this episode

“What did the council decide on item 42?” — answered with the speaker and the moment.

Transcript

Related