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=pooME9gMaL0

2. 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.106

6. MRD-guided maintenance discontinuation in myeloma (Secondary analysis of GEM2012MENOS65 trial): https://pubmed.ncbi.nlm.nih.gov/37506339/

Episode 9: Positive Passivity