03 Dec Alcyone Trial: DaraVMP New Standard for Transplant-Ineligible Newly Diagnosed Multiple Myeloma
MedicalResearch.com Interview with:
Maria-Victoria Mateos, MD, PhD
Associate Professor of Medicine
University of Salamanca
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Alcyone trial is a phase 3 trial in which Daratumumab, the CD38 mAb has been added to a standard of care for elderly newly diagnosed myeloma patients, VMP, and compared with VMP. The main finding is that the addition of dara to VMP resulted into a significant benefit in PFS with a 57% reduction in the risk of progression and/or death. In addition, the benefit was also reported in terms of ORR and CR rate and 45% of patients receiving Dara VMP achieved CR. Minimal residual disease was evaluated and was undetectable in 27% of the patients what it is relevant because a 5% increase was observed in comparison with the publication one year ago. This means that Daratumumab as maintenance after the first 9 cycles daraVMP was able to upgrade the quality of response. Toxicity profile was acceptable and no new safety signals were reported.
MedicalResearch.com: What should readers take away from your report?
Response: Dara plus VMP is a standard of care already approved by FDA and EMA to be used in the treatment of elderly patients with NDMM.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: In this study VMP was given for 9 cycles in combination with daratumumab in the experimental arm and beyond the cycle number 9, dara was given as continuous therapy and single agent. However, we know now that bortezomib can be safely administered for prolonged periods of time so my recommendations would be to prolong the treatment beyond the cycle number 9 not only with dara but bortezomib plus dara and the efficacy might be even improved. Bortezomib can be given every other week what it is not inconvenient for patients.
MedicalResearch.com: Is there anything else you would like to add?
Response: DaraVMP is a new standard of care for NDMM not eligible for transplant that can be potentially affordable in many countries due to the fact that bortezomib, melphalan and prednisone is not an expensive combination so dara would be the only new and more expensive agent. I have received honoraria derived from lectures and advisory boards from Janssen, Celgene, Takeda, Amgen, Abbvie, GSK and Pharmamar. In addition, I am the PI of the Alcyone trial.
One-Year Update of a Phase 3 Randomized Study of Daratumumab Plus Bortezomib, Melphalan, and Prednisone (D-VMP) Versccus Bortezomib, Melphalan, and Prednisone (VMP) in Patients (Pts) with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (NDMM): Alcyone
Meletios A Dimopoulos, MD1, Maria-Victoria Mateos, MD, PhD2, Michele Cavo, MD3*, Kenshi Suzuki, MD, PhD4, Andrzej Jakubowiak, MD, PhD5, Stefan Knop6*, Chantal Doyen, MD7, Paulo Lucio8*, Zsolt Nagy, MD, PhD9*, Polina Kaplan10*, Ludek Pour, MD11*, Mark Cook, MBChB, PhD12, Sebastian Grosicki, MD, PhD13, Andre H Crepaldi, MD14*, Anna Marina Liberati, MD15,16, Philip Campbell, MBBS, FRACP, FRCPA17, Tatiana Shelekhova18*, Sung-Soo Yoon, MD, PhD19*, Genadi Iosava, MD20*, Tomoaki Fujisaki, MD, PhD21*, Mamta Garg22*, Christopher Chiu, PhD23, Jianping Wang24*, Anupa Kudva, MD25*, Rachel Kobos, MD24, Susan Wroblewski, PhD26*, Ming Qi, MD, PhD23, Jesus F San-Miguel, MD, PhD27 and Joan Bladé, MD, PhD28
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