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
Launched by REGENERON PHARMACEUTICALS · Feb 6, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new drug called linvoseltamab to see how well it works for adults with relapsed or refractory multiple myeloma—a type of blood cancer that has come back after treatment or has not responded to previous therapies. The goal is to compare linvoseltamab to a combination of three other existing cancer drugs: elotuzumab, pomalidomide, and dexamethasone. Participants will be randomly assigned to receive either linvoseltamab or the combination treatment. Researchers want to find out how effective linvoseltamab is, what side effects it may cause, and how it compares in terms of improving symptoms and overall survival.
To be eligible for this trial, participants must be at least 18 years old, have had one to four previous treatments for multiple myeloma, and have measurable disease that can be assessed. They should also be in decent health with no major infections or recent cancer treatments. If you or a loved one is considering joining this trial, you can expect regular check-ups and assessments to monitor your response to the treatment and any side effects. This study is actively recruiting participants, aiming to provide more options for those facing challenges with current therapies.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • 1. Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
- • 2. 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.
- • 3. 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.
- • 4. Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol
- • 5. Adequate hematologic function and hepatic function within 7 days of randomization, as well as adequate renal and cardiac function and corrected calcium
- • 6. Life expectancy of at least 6 months
- Key Exclusion Criteria:
- • 1. Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- • 2. Prior treatment with elotuzumab and/or pomalidomide
- • 3. Participants with known MM brain lesions or meningeal involvement
- • 4. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
- • 5. History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment. Participants who have received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Steroids at doses equivalent to suppletion doses may be acceptable.
- • 6. Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed.
- • 7. History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder (Parkinson's disease or Parkinsonism).
- • 8. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug
- • 9. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in the protocol 10 Cardiac ejection fraction \<40%.
- • NOTE: Other protocol defined inclusion/exclusion criteria apply
About Regeneron Pharmaceuticals
Regeneron Pharmaceuticals, a leading biotechnology company, is dedicated to transforming the lives of patients through innovative medicines. Founded in 1988, the company specializes in the discovery, development, and commercialization of cutting-edge therapies for serious diseases, leveraging advanced genetic technologies and a robust pipeline of novel drug candidates. With a strong focus on areas such as ophthalmology, oncology, immunology, and rare diseases, Regeneron is committed to scientific excellence and collaboration, striving to deliver safe and effective treatments that address unmet medical needs and improve patient outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Durham, North Carolina, United States
Durham, North Carolina, United States
Seattle, Washington, United States
Lexington, Kentucky, United States
Paris, , France
Adelaide, South Australia, Australia
Heidelberg, Victoria, Australia
Edinburgh, Scotland, United Kingdom
Madrid, , Spain
Ramat Gan, , Israel
Hobart, Tasmania, Australia
Jerusalem, , Israel
Barcelona, , Spain
Launceston, Tasmania, Australia
Houston, Texas, United States
Herston, Queensland, Australia
Los Angeles, California, United States
Singapore, , Singapore
Herston, Queensland, Australia
Singapore, , Singapore
Camperdown, New South Wales, Australia
Portland, Oregon, United States
Tel Aviv, , Israel
London, , United Kingdom
Curitiba, , Brazil
Hamburg, , Germany
St Leonards, New South Wales, Australia
Ottawa, Ontario, Canada
Stony Brook, New York, United States
Santander, Cantabria, Spain
Majadahonda, Madrid, Spain
Santander, Cantabria, Spain
London, , United Kingdom
Malaga, , Spain
Paris, , France
Brussels, , Belgium
Lyon, , France
Taipei, , Taiwan
Fitzroy, Victoria, Australia
Taichung, , Taiwan
Taipei, , Taiwan
Bruxelles, , Belgium
Louisville, Kentucky, United States
Ottawa, Ontario, Canada
Tainan, , Taiwan
Zaragoza, , Spain
Jerusalem, , Israel
Kurume, Fukuoka, Japan
Porto Alegre, Rio Grande Do Sul, Brazil
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Taipei, , Taiwan
Kaohsiung, , Taiwan
Manchester, , United Kingdom
Cambridge, , United Kingdom
Los Angeles, California, United States
San Giovanni Rotondo, Foggia, Italy
Tel Aviv, , Israel
Changhua City, , Taiwan
Majadahonda, Madrid, Spain
Fukushima, , Japan
Varese, , Italy
Jerusalem, , Israel
Hwasun, , Korea, Republic Of
Sevilla, , Spain
Saint Cloud, , France
Pamplona, Navarra, Spain
Seoul, , Korea, Republic Of
Yvoir, , Belgium
Hamburg, , Germany
Ogaki, Gifu, Japan
Busan, , Korea, Republic Of
Kent Ridge, , Singapore
Seoul, , Korea, Republic Of
Valencia, , Spain
Madrid, , Spain
Sapporo, Hokkaido, Japan
Valencia, , Spain
Suita Shi, Osaka, Japan
Kaohsiung, , Taiwan
Haifa, , Israel
Maebashi, Gunma, Japan
Kofu, Yamanashi, Japan
Seattle, Washington, United States
Okayama, , Japan
London, , United Kingdom
Busan, , Korea, Republic Of
Kaohsiung, , Taiwan
Singapore, , Singapore
Oviedo, Asturias, Spain
Kumamoto, , Japan
Santiago De Compostela, A Coruna, Spain
Birmingham, West Midlands, United Kingdom
Haifa, , Israel
Lublin, Lubelskie, Poland
Salvador, Bahia, Brazil
Ravenna, , Italy
Villejuif, Ile De France, France
Palma De Mallorca, Islas Baleares, Spain
Vitoria Gasteiz, , Spain
London, , United Kingdom
Nijmegen, Gelderland, Netherlands
Shibuya Ku, Tokyo, Japan
Dordrecht, Zuid Holland, Netherlands
Iruma Gun, Saitama, Japan
Taipei, , Taiwan
Pamplona, Navarra, Spain
Cambridge, Cambrigeshire, United Kingdom
Geelong, Victoria, Australia
Terrassa, Barcelona, Spain
Katowice, , Poland
Melbourne, Victoria, Australia
Hwasun, South Jeolla, Korea, Republic Of
Pozuelo De Alarcon, Madrid, Spain
Zaragoza, , Spain
San Giovanni Rotondo, Foggia, Italy
Ogaki, , Japan
Hualien City, , Taiwan
Sendai, , Japan
Ancona, , Italy
Barcelona, , Spain
Charlotte, North Carolina, United States
Genova, , Italy
Tokushima Shi, Tokushima, Japan
Curitiba, Parana, Brazil
Haifa, , Israel
Edinburgh, Scotland, United Kingdom
Taipei, , Taiwan
Vina Del Mar, Valparaiso, Chile
Antwerp, , Belgium
Madrid, , Spain
São Paulo, , Brazil
Haifa, North, Israel
Louisville, Kentucky, United States
Terrassa, Barcelona, Spain
Paris, , France
London, , United Kingdom
Santiago De Compostela, , Spain
Roeselare, West Vlaanderen, Belgium
Madrid, , Spain
Seoul, , Korea, Republic Of
Santiago, Region Metropolitana, Chile
Madrid, , Spain
Stony Brook, New York, United States
Incheon, Gyeonggi, Korea, Republic Of
Jeonju, Jeollabuk Do, Korea, Republic Of
Toronto, Ontario, Canada
Jeonju, , Korea, Republic Of
Auchenflower, Queensland, Australia
Gainesville, Florida, United States
Madrid, , Spain
Nedlands, Western Australia, Australia
Tainan City, , Taiwan
Yvoir, Namur, Belgium
Catania, , Italy
Girona, , Spain
Palma, Balearic Islands, Spain
London, , United Kingdom
Pavia, , Italy
London, , United Kingdom
Hualien City, , Taiwan
Bologna, , Italy
Incheon, , Korea, Republic Of
Busan, , Korea, Republic Of
Jeonju, , Korea, Republic Of
Geelong, Victoria, Australia
Alicante, , Spain
Melbourne, Victora, Australia
Villejuif, Paris, France
Incheon, , Korea, Republic Of
Alicante, , Spain
Madrid, , Spain
Bydgoszcz, , Poland
Paris, , France
Palma Mallorca, Baleares, Spain
Pozuelo, Madrid, Spain
São Paulo, , Brazil
South Brisbane, Queensland, Australia
Toronto, Ontario, Canada
Seoul, , Korea, Republic Of
Ravenna, , Italy
Turin, , Italy
Palma De Mallorca, Baleares, Spain
Lille, , France
Meldola, Forli Cesena, Italy
Reggio Emilia, , Italy
Gijon, Asturias, Spain
Gijon, Asturias, Spain
Ramat Gan, Hamerkaz, Israel
Torino, , Italy
Sutton, Surrey, United Kingdom
Bento Goncalves, Rio Grade Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Lages, Santa Catarina, Brazil
Pavia, , Italy
Taoyuan, , Taiwan
Badalona, Barcelona, Spain
Santiago, Las Condes, Chile
Pessac, Gironde, France
Gdańsk, Pomorskie, Poland
Varese, Lombardy, Italy
Barcelona, , Spain
Changhua City, Changhua County, Taiwan
Bologna, , Italy
Nijmegen, Gelderland, Netherlands
Santiago, , Chile
São Paulo, , Brazil
Toronto, Ontario, Canada
Tuebingen, Baden Wuerttemberg, Germany
Alessandria, , Italy
Viagrande, , Italy
Lodz, Lodzkie, Poland
Leon, , Spain
Seville, , Spain
Birmingham, West Midlands, United Kingdom
Sao Paulo, , Brazil
Porto Alegre, , Brazil
Rio De Janeiro, , Brazil
São Paulo, , Brazil
Barcelona, , Spain
Taichung, , Taiwan
Leipzig, Saxony, Germany
Alicante, Comunidad Valenciana, Spain
Paris, Ile De France, France
Tokushima, , Japan
Bydgoszcz, Kujawsko Pomorskie, Poland
Santiago, , Chile
Seoul, , Korea, Republic Of
Las Condes, , Chile
Luebeck, , Germany
Antwerp, , Belgium
Limache, Valparaiso, Chile
Pessac, Gironde, France
Las Condes, Santiago, Chile
Morioka, Iwate, Japan
Fujimi, Yamanashi, Japan
Kamogawa, , Japan
Madrid, Salamanca, Spain
Chiba Shi, Tiba, Japan
Lyon, , France
Lexington, Kentucky, United States
Stony Brook, New York, United States
Heidelberg, Victoria, Australia
Nedlands, Western Australia, Australia
Roeselare, West Vlaanderen, Belgium
Salvador, Bahia, Brazil
Bento Goncalves, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Centro, , Brazil
Sao Paulo, , Brazil
Sao Paulo, , Brazil
Sao Paulo, , Brazil
Toronto, Ontario, Canada
Santiago, Region Metropolitana, Chile
Santiago, Region Metropolitana, Chile
Santiago, Region Metropolitana, Chile
Lille, Hauts De France, France
Paris, , France
Tuebingen, Baden Wuerttemberg, Germany
Leipzig, , Germany
Luebeck, , Germany
Meldola, Forli Cesena, Italy
Candiolo, Torino, Italy
Alessandria, , Italy
Reggio Emilia, , Italy
Torino, , Italy
Kamogawa, Chiba, Japan
Shibukawa, Gunma, Japan
Kita Ku, Okayama, Japan
Seoul, , Korea, Republic Of
Gdansk, Pomorskie, Poland
Lublin, , Poland
Vitoria Gasteiz, Alava, Spain
Badalona, Barcelona, Spain
Leon, Castilla Y Leon, Spain
Barcelona, , Spain
Girona, , Spain
Taoyuan, , Taiwan
Villejuif, Ile De France, France
Paris, Ile De France, France
Rio De Janeiro, , Brazil
Lyon, Auvergne Rhone, France
Luebeck, Ratzeburger, Germany
Torino, Piemonte, Italy
Taoyuan, Hunan Province, Taiwan
Gainesville, Florida, United States
Patients applied
Trial Officials
Clinical Trial Management
Study Director
Regeneron Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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