Vincent Rajkumar, Professor of Medicine at the Mayo Clinic in Rochester and Editor‑in‑Chief at Blood Cancer Journal, shared a post on X about a paper he co-authored with colleagues published in NEJM:
“Trials like AQUILA are great examples to study the design, conduct, and interpretation of randomized trials.
You may see experts argue about how to interpret the trial and what level of benefit will justify practice change. That’s a good thing. But whatever the case is, for those interested in clinical research, studying trials like AQULA in detail will be of value.
When a trial is designed, you have no control over the outcome. The outcome of a trial doesn’t make a trial good or bad. But it’s whether it was designed, conducted, and reported fairly.
The AQUILA trial manuscript and the supplemental material have a lot of information that we thought clinicians and investigators would need. You can also find a detailed discussion of the data from the ODAC hearing.
I’m glad to highlight this trial, which has today led to the FDA approval of daratumumab for high-risk smoldering myeloma. It was already approved in July for this indication in Europe.”
Title: Daratumumab or Active Monitoring for High-Risk Smoldering Multiple Myeloma
Authors: Meletios A. Dimopoulos, Peter M. Voorhees, Fredrik Schjesvold, Yael C. Cohen, Vania Hungria, Irwindeep Sandhu, Jindriska Lindsay, Ross I. Baker, Kenshi Suzuki, Hiroshi Kosugi, Mark-David Levin, Meral Beksac, Keith Stockerl-Goldstein, Albert Oriol, Gabor Mikala, Gonzalo Garate, Koen Theunissen, Ivan Spicka, Anne K. Mylin, Sara Bringhen, Katarina Uttervall, Bartosz Pula, Eva Medvedova, Andrew J. Cowan, Philippe Moreau, Maria-Victoria Mateos, Hartmut Goldschmidt, Tahamtan Ahmadi, Linlin Sha, Annelore Cortoos, Eva G. Katz, Els Rousseau, Liang Li, Robyn M. Dennis, Robin Carson, and S. Vincent Rajkumar
You can read the Full Article in The New England Journal of Medicine.
You can find more posts featuring Vincent Rajkumar on OncoDaily.