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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
Sponsor: Regeneron Pharmaceuticals
Summary
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
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
410
Start Date
2023-09-18
Completion Date
2033-04-19
Last Updated
2026-10-07
Healthy Volunteers
No
Interventions
Linvoseltamab
REGN5458 will be administered by intravenous (IV) infusion
Elotuzumab
Elotuzumab will be administered by IV infusion
Pomalidomide
Pomalidomide capsules will be administered by mouth (PO)
Dexamethasone
Dexamethasone tablets/capsules will be administered PO and/or by IV infusion
Locations (159)
University of California Los Angeles (UCLA)
Los Angeles, California, United States
University of Florida Division of Sponsored Programs
Gainesville, Florida, United States
University of Kentucky, Markey Cancer Center Clinical Research Organization
Lexington, Kentucky, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Stony Brook University
Stony Brook, New York, United States
Levine Cancer Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Kaiser Permanente Northwest
Portland, Oregon, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Icon Cancer Centre - Wesley
Auchenflower, Queensland, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Launceston General Hospital
Launceston, Tasmania, Australia
St Vincent's Hospital
Fitzroy, Victoria, Australia
University Hospital Geelong
Geelong, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
One Clinical Research at Hollywood Private Hospital
Nedlands, Western Australia, Australia
Clinique Universitaire de Mont Godinne
Yvoir, Namur, Belgium
AZ Delta Algemeen Ziekenhuis Delta
Roeselare, West-Vlaanderen, Belgium
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
IDOR - Sao Rafael Salvador Bahia
Salvador, Estado de Bahia, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Associacao Dr Bartholomeu Tacchini
Bento Gonçalves, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Centro Gaucho Integrado
Porto Alegre, Rio Grande do Sul, Brazil
Animi Unidade de Tratamento Oncologico
Lages, Santa Catarina, Brazil
Instituto Americas de Ensino e Pesquisa
Rio de Janeiro, Brazil
A Beneficencia Portuguesa de Sao Paulo, Oncology House
São Paulo, Brazil
Instituto DOr de Pesquisa e Ensino
São Paulo, Brazil
AC Camargo Cancer Center
São Paulo, Brazil
Clinica Medica Sao Germano
São Paulo, Brazil
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
University Health Network-Princess Margaret Cancer Center
Toronto, Ontario, Canada
Hospital Clinico Universidad de Los Andes
Santiago, Las Condes, Chile
Clinica Alemana de Santiago
Santiago, Santiago Metropolitan, Chile
Fundacion Arturo Lopez Perez
Santiago, Santiago Metropolitan, Chile
Clinica UC San Carlos de Apoquindo
Santiago, Santiago Metropolitan, Chile
Centro Oncologia de Precision Universidad Mayor
Santiago, Santiago Metropolitan, Chile
Centro de Investigaciones Clinicas Vina del Mar
Viña del Mar, Valparaiso, Chile
Centre Leon Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)
Lyon, Auvergne-Rhone, France
Centre Francois Magendie
Pessac, Gironde, France
Centre Hospitalier Universitaire de Lille
Lille, Hauts-de-France, France
Hopital Saint Louis, APHP
Paris, France
Saint Antoine Hospital
Paris, France
Institut Curie
Saint-Cloud, France
Hopital Necker
Paris, Île-de-France Region, France
Gustave Roussy
Villejuif, Île-de-France Region, France
Medical Clinic II
Tübingen, Baden-Wurttemberg, Germany
Universitat zu Lubeck Neuromuskulares Zentrum
Lübeck, Ratzeburger, Germany
University Hospital Hamburg Eppendorf
Hamburg, Germany
University Hospital Leipzig - Hematology and Cellular Therapy
Leipzig, Germany
Rambam Health Care Campus
Haifa, North, Israel
Lady Davis Carmel Medical Center
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Hadassah Medical Center
Jerusalem, Israel
Sheba Medical Center
Ramat Gan, Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy
Istituto Romagnolo per lo Studio Dei Tumori Dino Amadori
Meldola, Forli-Cesena, Italy
Ospedale Policlinico San Martino IRCCS
Genoa, Genova, Italy
Azienda Ospedaliera Nazionale SS - Antonio e Biagio e Cesare Arrigo
Alessandria, Piedmont, Italy
A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont, Italy
IRCCS Fondazione Piemontese Oncologica Candiolo
Candiolo, Torino, Italy
AOU Ospedali Riuniti di Ancona
Ancona, Italy
Policlinico S. Orsola- Malpighi
Bologna, Italy
Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
Catania, Italy
Universita degli Studi di Pavia - Fondazione IRCCS Policlini
Pavia, Italy
Ospedale Santa Maria delle Croci
Ravenna, Italy
AUSL IRCCS OF Reggio Emilia - Clinical Study Location -
Reggio Emilia, Italy
Ospedale di Circolo e Fondazione Macchi Varese
Varese, Italy
Aichi Medial University Hospital
Nagakute, Aichi-ken, Japan
Chiba Cancer Center
Chiba, Chiba, Japan
Kameda General Hospital
Kamogawa, Chiba, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Ogaki Municipal Hospital
Ōgaki, Gifu, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
NHO Shibukawa Medical Center
Shibukawa, Gunma, Japan
Sapporo Hokuyu Hospital
Sapporo, Hokkaido, Japan
Iwate Medical University Hospital
Shiwa-gun, Iwate, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, Kumamoto, Japan
National Hospital Organization Okayama Medical Center
Kita-ku, Okayama-ken, Japan
Osaka University Hospital
Suita-shi, Osaka, Japan
Saitama Medical University Hospital
Iruma-gun, Saitama, Japan
Tokushima Prefectural Central Hospital
Tokushima, Tokushima, Japan
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Fukushima Medical University
Fukushima, Japan
National Hospital Organization Sendai Medical Center
Sendai, Japan
Radboudumc
Nijmegen, Gelderland, Netherlands
Albert Schweitzer Hospital
Dordrecht, South Holland, Netherlands
University Clinical Center / Medical University of Gdansk
Gdansk, Pomeranian Voivodeship, Poland
Szpital Uniwersytecki Nr2 Bydgoszcz
Bydgoszcz, Poland
Pratia Onkologia Katowice
Katowice, Poland