I loved all the best of #ASH21 threads this year, but in this thread I highlight 5 deeply flawed marketing advertisements (studies) that should not change practice. #mmsm 🧵
I will start by saying that it is very hard to criticize studies without offending people, so I apologize sincerely and it is my intention only to call out what I perceive as flawed. I may be wrong, and many of these authors have done more than I ever will for myeloma
We had chance to universally give dara upon progression to control arm in newly diagnosed MM in 3 different trials. But we didn’t. And now we shouldn’t just create a modeled scenario with so many assumptions and say it’s better to give dara up front
As a me-too drug offers little advantages over dara, isatuximab could have ran 3 vs 3 trials, or done modeling comparing vs dara with same backbone. But here we get a comparison of dara/len/dex versus isa/carf/dex. Fundamentally diff studies/patients
Breaks my heart. You compare people that were fit enough and had better biology to stay on Selinexor for longer to people who couldn’t stay on it for longer. Beyond marketing, what is the scientific value of such an inherently flawed analysis?
Study 4:
Cilta-cel is great (for patients with biology stable enough to wait to get therapy).
We don’t need flawed comparisons with patients from different areas of the world, many of whom are getting doublets to know that. What is the value, beyond marketing- of such a study?
No subgroup analysis can salvage a study with a fundamentally unethical control arm.I see efforts made to highlight unique role of seli in del 17p- but remember- it’s compared to doublet that nobody uses, and it’s likely all statistical noise.
Ten important observations about myeloma and its precursors that I often discuss with patients and teach to trainees in my clinic.
An educational thread
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#mmsm
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1) Most, but not all disease progressions at the time of relapse are biochemical (as in myeloma proteins increasing) and not clinical (as in new organ damage, anemia, bone lesions etc)
2) For those with high-risk disease, remissions appear to be very short without a transplant, and the role of transplant even more important, as shown in this excellent meta-analysis of high-risk disease patients across trials.
Our trial of surveillance incorporating DW-whole body MRI q6 mo for high-risk smoldering myeloma is active.
This is a multi-center effort that aims to define natural history of SMM, and show that close surveillance can prevent morbidity while keeping people off treatment
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This trial involves recruiting 100 patients with high-risk SMM and surveilling closely with q6 month MRI, yearly marrows, and frequent labs.
We aim to show that "morbid" progression events such as fractures, bone lesions and renal injury that doesnt promptly reverse are rare
Link:
I sincerely wish to thank the key collaborators who have helped design this study- my dear friend @rajshekharucms over many calls and meetings, @AaronGoodman33 , @rubinstein_md and Dr. Nishi Shah.
Inspired by a recent discussion on twitter/X about a trial- here’s a thread about the importance of intent to treat analysis, and the caveats/shortcomings of per-protocol or analysis per “compliance/adherence”.
Buckle yourself up for an educational 🧵
This was a trial of Mediterranean diet in reducing breast cancer recurrence.
We know the Mediterranean diet is good for you- in a rigorous randomized trial, it has actually reduced cardiovascular morbidity.