An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti- BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients With Relapsed/Refractory Multiple Myeloma (LINKER-MM3)
An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti- BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients With Relapsed/Refractory Multiple Myeloma (LINKER-MM3)
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:
Key Inclusion Criteria:
Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg. pain) may be allowed after discussion with the Medical Monitor.
Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies, including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or after the last therapy as defined by the 2016 IMWG criteria. Participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory, as described in the protocol.
Note: Participants in Israel also must have previously received a CD38 antibody. Participants in the EU and the UK must have previously received 2 to 4 prior lines of therapy, including a CD38 antibody.
Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol
Adequate hematologic function and hepatic function within 7 days of randomization, as well as adequate renal and cardiac function and corrected calcium
Life expectancy of at least 6 months
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria apply
clinicaltrials@regeneron.com844-734-6643
Los Angeles, California 90095, United States
Gainesville, Florida 32611, United States
Lexington, Kentucky 40536, United States
Nedlands, Western Australia 6009, Australia
Bento Gonçalves, Rio Grande do Sul 95700-084, Brazil
Porto Alegre, Rio Grande do Sul 90035-903, Brazil
São Paulo, 01321000, Brazil
Toronto, Ontario M5G 2M9, Canada
Santiago, Santiago Metropolitan 7550000, Chile
Santiago, Santiago Metropolitan 7560907, Chile
Viña del Mar, Valparaiso 2540488, Chile
Lyon, Auvergne-Rhone 69008, France
Lübeck, Ratzeburger 23538, Germany
Meldola, Forli-Cesena 47014, Italy
Alessandria, Piedmont 15121, Italy
Turin, Piedmont 10126, Italy
Catania, 95123, Italy
Pavia, 27100, Italy
Reggio Emilia, 42123, Italy
Kashiwa-shi, Chiba 277-8577, Japan
Kita-ku, Okayama-ken 701-1192, Japan
Suita-shi, Osaka 565-0871, Japan
Iruma-gun, Saitama 350-0495, Japan
Shibuya-ku, Tokyo 150-8935, Japan
Gdansk, Pomeranian Voivodeship 80-219, Poland
Lublin, 20-954, Poland
Lodz, Łódź Voivodeship 93-510, Poland
Incheon, Gyeonggi-do 21565, South Korea
Hwasun, Jeollanam-do 58128, South Korea
Santiago de Compostela, A Coruna 15706, Spain
Palma Mallorca, Balearic Islands 07198, Spain
León, Castille and León 24070, Spain
Pozuelo de Alarcón, Madrid 28223, Spain
Alicante, Valencia 03010, Spain
Taoyuan, Hunan Province 33305, Taiwan
Birmingham, West Midlands B15 2TH, United Kingdom