A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma

Recruiting now · Phase 3

Conditions studied: Relapsed Refractory Multiple Myeloma (RRMM)

In brief

This study is researching an experimental drug called linvoseltamab, also called REGN5458. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies). This study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of this study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone, (called EPd) in participants who have returned after having received prior treatment that included lenalidomide, a proteosome inhibitor, and (for participants in some countries) a cluster of differentiation 38 (CD38) antibody. Half of the participants in this study will get linvoseltamab, and the other half will get EPd. This study is looking at several other research questions, including: * How long participants benefit from receiving linvoseltamab compared with EPd * How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much * What side effects happen from taking linvoseltamab compared to EPd * How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd * If there is any improvement in pain after treatment with linvoseltamab compared to EPd

Key facts

Study ID

NCT05730036

Run by

Regeneron Pharmaceuticals

People needed

410

Starts

2023-09-18

Expected to finish

2033-04-19

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Tokushima Prefectural Central Hospital — Tokushima, Tokushima, Japan (enrolling)
• National Hospital Organization Kumamoto Medical Center — Kumamoto, Kumamoto, Japan (enrolling)
• Gunma University Hospital — Maebashi, Gunma, Japan (enrolling)
• Saitama Medical University Hospital — Iruma-gun, Saitama, Japan (enrolling)
• Catalan Institute of Oncology (ICO) Hospitalet — Barcelona, Spain (enrolling)
• National Hospital Organization Okayama Medical Center — Kita-ku, Okayama-ken, Japan (enrolling)
• Kameda General Hospital — Kamogawa, Chiba, Japan (enrolling)
• Ogaki Municipal Hospital — Ōgaki, Gifu, Japan (enrolling)
• Iwate Medical University Hospital — Yahaba, Iwate, Japan (enrolling)
• Osaka University Hospital — Suita-shi, Osaka, Japan (enrolling)
• Fukushima Medical University — Fukushima, Japan (enrolling)
• National Hospital Organization Sendai Medical Center — Sendai, Japan (enrolling)
• Yamanashi Prefectural Central Hospital — Kofu, Yamanashi, Japan (enrolling)
• Japanese Red Cross Medical Center — Shibuya-ku, Tokyo, Japan (enrolling)
• Aichi Medial University Hospital — Nagakute, Aichi-ken, Japan (enrolling)
• Chiba Cancer Center — Chiba, Chiba, Japan (enrolling)
• National Cancer Center Hospital East — Kashiwa-shi, Chiba, Japan (enrolling)
• Kurume University Hospital — Kurume, Fukuoka, Japan (enrolling)
• NHO Shibukawa Medical Center — Shibukawa, Gunma, Japan (enrolling)
• Sapporo Hokuyu Hospital — Sapporo, Hokkaido, Japan (enrolling)
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Royal Brisbane and Women's Hospital — Herston, Queensland, Australia
• Duke University Medical Center — Durham, North Carolina, United States
• Icon Cancer Centre - Wesley — Auchenflower, Queensland, Australia
• Cliniques Universitaires Saint-Luc — Brussels, Belgium

Full record on ClinicalTrials.gov

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