A Phase 1 study of belantamab mafodotin in combination with standard of care in newly diagnosed multiple myeloma: An interim analysis of DREAMM-9
Dr. Saad Usmani presents the results of an ongoing Phase One randomized open-label study. The study aims to evaluate the safety and tolerability of Belantamab mafodotin (belamaf) in combination with either VRd (Bortezomib, Lenalidomide, Dexamethasone) or Rd (Lenalidomide, Dexamethasone) in newly diagnosed, transplant-ineligible multiple myeloma patients. The primary goal is to establish the recommended phase three dose for these combinations. The study includes several cohorts with different dosing schedules.
- The study evaluates the combination of Bellamaf with VRD or RD in newly diagnosed, transplant-ineligible multiple myeloma patients.
- As of March 2023, 93 patients have been randomized across seven cohorts, and efficacy and safety data are available for 91 patients.
- The median age of patients is 73 years, and approximately half of them are male.
- Belamaf is a BCMA-directed antibody drug conjugate.
- Overall response rates of 79% to 100% were observed across the various cohorts.
-- The most important safety concern is keratopathy (corneal disorder) and visual acuity scale issues, which were observed in 64% to 92% of patients in cohorts one through five and only one patient each in cohorts six and seven.
- The ocular side effects appear to be better for lower doses and less frequent dosing schedules.
- Longer follow-up is needed to further assess the safety and efficacy of the combinations.
Authors:
Saad Zafar Usmani, Michał Mielnik, Ja Min Byun, Aránzazu Alonso Alonso, Al-Ola A. Abdallah, Mamta Garg, HANG QUACH, Chang-Ki Min, Wojciech Janowski, Enrique M. Ocio, Katja Weisel, Albert Oriol, Irwindeep Sandhu, Paula Rodríguez-Otero, Karthik Ramasamy, Jacqueline L. Egger, Danae Williams, Jie Ma, Morrys C. Kaisermann, Marek Hus
Clinical trial information: NCT04091126
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Founded in 1990, the International Myeloma Foundation (IMF) is the first and largest organization focusing specifically on multiple myeloma. The IMF’s reach extends to more than 525,000 members in 140 countries worldwide. The IMF is dedicated to improving the quality of lives of myeloma patients while working toward prevention and a cure through our four founding principles: Research, Education, Support, and Advocacy.
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