Exciting to see results of lenalidomide in smoldering myeloma. It’s clear that lenalidomide prolongs time to progression and to symptomatic disease. I will point out reasons why I am not ready to use this regimen for smoldering myeloma. [thread] #mmsm ascopubs.org/doi/full/10.12…
1) Lead time bias. Not surprising that treating pts earlier will delay progression. We are treating them! We have to think beyond progression too!
2) Only 11/90 pts in placebo arm experienced bony disease and 8/90 renal failure at progression. Also we don’t know severity! #mmsm
2) Only 11/90 pts in placebo arm experienced bony disease and 8/90 renal failure at progression. Also we don’t know severity! #mmsm
3) Many pts discontinued lenalidomide. 30/92 because of adverse events and 22/92 because of withdrawal/refusal. Similar to experience with maintenance, this drug is not always easy for patients!
4) HRQOL wasn’t worse with Len, but it also wasn’t better despite ⬆️ PFS
#mmsm
4) HRQOL wasn’t worse with Len, but it also wasn’t better despite ⬆️ PFS
#mmsm
5) Predominantly partial responses were seen, which leads me to...
6) It will be important to know which regimens patients received when they progressed. Presumably, Len-free regimens. This affects how we would normally treat patients at diagnosis of MM and relapse. #mmsm
6) It will be important to know which regimens patients received when they progressed. Presumably, Len-free regimens. This affects how we would normally treat patients at diagnosis of MM and relapse. #mmsm
7) Overall survival comparison in this trial may be dependent on subsequent regimens received! Maybe Obs➡️VRd is > Len ➡️something else?
8) If the argument is for treating Hi risk smoldering, then we should take intensive curative approach (a la GEM-CESAR or ASCENT trial). #mmsm
8) If the argument is for treating Hi risk smoldering, then we should take intensive curative approach (a la GEM-CESAR or ASCENT trial). #mmsm
9) and/or we should just consider reclassifying hi risk SMM as MM, as others have suggested.
All in all, a very thought provoking study but I need more data before changing practice. Conversations with pts just got a lot harder! #mmsm
All in all, a very thought provoking study but I need more data before changing practice. Conversations with pts just got a lot harder! #mmsm
I slept on this & had 2 add’l thoughts:
10) What is the quality of the stem cell grafts? Collected after 4-6 cycles of Len, but most achieved a PR & time to response was 5 months.
11) What does this mean for frontline clinical trial? Long term Len may lead to ineligibility #mmsm
10) What is the quality of the stem cell grafts? Collected after 4-6 cycles of Len, but most achieved a PR & time to response was 5 months.
11) What does this mean for frontline clinical trial? Long term Len may lead to ineligibility #mmsm
12) Others have rightly brought up the QuiRedex study which showed OS benefit. We must recall that pts also got dex and could get dex during maintenance. This study predated update to diagnostic criteria for MM so pts were included who would now be considered to have myeloma
