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ASH 2025 | VMP ± Dara versus Rd ± Dara in transplant-ineligible patients with myeloma: a Phase IV trial
Mattia D’Agostino, MD, University of Turin, Turin, Italy, discusses the results of the randomized Phase IV Real MM trial (NCT03829371), which compared bortezomib-melphalan-prednisone (VMP) +/- daratumumab (Dara) to lenalidomide-dexamethasone (Rd) +/- Dara in transplant-ineligible patients with multiple myeloma treated in the real-world setting. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
So, in transplant ineligible patients, before the introduction of Daratumumab, the two standards of care were VMP and Rd. After the addition of Daratumumab, according to the two registrational studies, the MAIA and the ALCYONE trial, DARA-RD and DARA-VMP became the standard of care. So in Italy, we tried to design a phase four clinical study, randomizing real-world patients, basically without any inclusion criteria, to DARA-RD or DARA-VMP...
So, in transplant ineligible patients, before the introduction of Daratumumab, the two standards of care were VMP and Rd. After the addition of Daratumumab, according to the two registrational studies, the MAIA and the ALCYONE trial, DARA-RD and DARA-VMP became the standard of care. So in Italy, we tried to design a phase four clinical study, randomizing real-world patients, basically without any inclusion criteria, to DARA-RD or DARA-VMP.
So what we found is that with a current follow-up of 20 months, basically the outcome is pretty similar. There is a little bit more early mortality in the DARA-VMP group and this was mainly due to the death of some frail patients. And these are truly frail patients because it comes from the community – they are not selected. Moreover, we found that in the first part of the study, the randomization was VMP versus RD. So even with 20 months of follow-up the PFS was better in the Dara arms and surprisingly even with 20 months of follow-up the overall survival of the Dara-RD arm was better than RD. Moreover with the addition of Daratumumab, we did not observe an excess of PFS or OS events in high-risk patients that we previously showed in the VMP versus RD arm with an advantage of VMP. With the addition of Daratumumab, we do not see any more this effect, maybe because there is a synergistic effect of daratumumab in addition to lenalidomide in this cohort of patients.
Moreover, we were very happy to reproduce in the real world the data from the clinical trials, also in terms of MRD negativity. We measured MRD negativity in these patients and the rate of MRD negative patients both in the DARA-RD and the DARA-VMP arm were really similar to what was described in the registrational study. So these two regimens basically even in the real world setting work really well.
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