ASH 2025 | Isa-VRd in older patients with/without frailty criteria: pooled analysis in newly diagnosed myeloma

In the last years, quadruplets have become a standard of care for the treatment of myeloma patients, elderly myeloma patients. And this is quadruplets, including anti-CD38 monoclonal antibodies plus VRD, based on the CEPHEUS and the IMROZ studies. The concern comes, or the question comes, if we can use this quadruplet for all patients, particularly those very old or with frailty criteria. And to give some light to these questions, we have done a pooled analysis of the frail and old patients treated in the IMROZ, the Phase III IMROZ study, with Isa-VRD or the phase 1 study also with this combination that gave rise to the basis for this phase 3 study. This pooled analysis combined or included 340 patients, 260 from the IMROZ and 70 patients from the TCD13, which is the phase one study.

What we saw in this study, particularly the main results were that, if we speak about the age, the PFS was a bit lower in those patients that were older than 75 years old. That was statistically significant. And regarding the frailty in those patients that were 75 years or younger or older than 75 years old, dividing them by the frailty score, we saw that those patients that were frail had a slightly lower PFS in both the young and the elderly patients, although that was not statistically significant. Then we analyzed also the response rate. The response rate was similar for those patients young and elderly than 75 years old, but it was particularly the patients with frailty scores, particularly those old patients had a lower response rate. And this was particularly important in the MRD negativity and the sustained MRD negativity rate. We have around 40% of MRD negativity rate in the whole population in these patients, and it was 27, around 25% in those patients that were old, older than 75 and with frailty, some frailty scores. Regarding safety, what is the last part. Safety was quite similar, although there were some signs of a bit less tolerability in those patients that were frail. 

What is the main conclusion that I think is the most important part of this? So we can use this quadruplet for the majority of our patients, young and older than 75, but probably we have to be a bit more cautious for those patients that are older than 75 and that are frail. In these cases, probably a quadruplet could be too much, and we should move for a triplet. But for the majority of patients, even older than 75 years old, I think we can also still use this quadruplet, which is a great opportunity for these myeloma patients.

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