Importance of MRD Negativity in Myeloma and Trial-Level Surrogacy Analysis

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/