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Brief Title: 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
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)
Study ID: NCT05730036
Brief 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
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UCLA, Los Angeles, California, United States
Norton Cancer Institute - St. Matthews Campus, Louisville, Kentucky, United States
Stony Brook University Hospital, Stony Brook, New York, United States
Levine Cancer Center, Charlotte, North Carolina, United States
Kaiser Permanente Northwest, Portland, Oregon, United States
University of Washington-Seattle Cancer Care Alliance, Seattle, Washington, United States
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Royal Brisbane Hospital, Herston, Queensland, Australia
Integrated Clinical Oncology Network, South Brisbane, Queensland, Australia
University Hospital Geelong, Geelong, Victoria, Australia
Austin Hospital, Heidelberg, Victoria, Australia
St Vincents Hospital Melbourne, Melbourne, Victoria, Australia
Hospital Sao Rafael, Salvador, Bahia, Brazil
Associacao Dr Bartholomeu Tacchini (Instituto Tacchini De Pesquisa Em Saude), Bento Goncalves, Rio Grade Do Sul, Brazil
Hospital Mae de Deus Center, Porto Alegre, Rio Grande Do Sul, Brazil
ANIMI, Lages, Santa Catarina, Brazil
Instituto D'Or de Pesquisa e Ensino, São Paulo, , Brazil
The Ottawa Hospital, Ottawa, Ontario, Canada
University Health Network (UHN) - Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Hopital Haut leveque-service d'Hematologie, Pessac, Gironde, France
Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP, Villejuif, Paris, France
Centre Hospitalier Universitaire (CHU) de Lille, Lille, , France
Hopital Universitaire Necker, Paris, , France
Hopital Saint Antoine, Paris, , France
The Chaim Sheba Medical Center, Ramat Gan, Hamerkaz, Israel
Rambam health care Campus, Haifa, , Israel
Carmel Medical Center, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Istituto Romagnolo per lo Studio Dei Tumori "Dino Amadori", Meldola, Forli Cesena, Italy
AOU Ospedali Riuniti di Ancona, Ancona, , Italy
IRCCS Fondazione Policlinico San Matteo Pavia, Pavia, , Italy
U.O.C. Ematologia Ospedale Santa Maria delle Croci, Ravenna, , Italy
AUSL IRCCS OF Reggio Emilia, Reggio Emilia, , Italy
University of Torino, Division of Hematology, Torino, , Italy
Candiolo Cancer Institute, FPO, IRCCS, Turin, , Italy
Inje University Busan Paik Hospital, Busan, , Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Jeonbuk National University Hospital, Jeonju, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul St. Marys Hospital, Seoul, , Korea, Republic of
Uniwersyteckie Centrum Kliniczne, Gdańsk, Pomorskie, Poland
Pratia Onkologia Katowice, Katowice, , Poland
National University Hospital, Kent Ridge, , Singapore
Singapore General Hospital, Singapore, , Singapore
Hospital de Cabueñes, Gijon, Asturias, Spain
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
Hospital universitari Son LLatzer, Palma de Mallorca, Baleares, Spain
Institut Catala dOncologia, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital Universitari Son Espases, Palma de Mallorca, Islas Baleares, Spain
Hospital Universitario Quirónsalud Madrid, Pozuelo, Madrid, Spain
Hospital Universitario de Navarra, Pamplona, Navarra, Spain
Hospital Gral. Universitari D'Alacant Y C.E Babel (Hospital General De Alicante), Alicante, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital Universitari de Girona Dr. Josep Trueta - Institut Catala d'Oncologia, Girona, , Spain
Universitary Hospital La Princesa, Madrid, , Spain
Clinica Universidad de Navarra - Sede Madrid, Madrid, , Spain
Hospital Fundación Jimenez Diaz, Madrid, , Spain
Hospital Clinico Universitario Santiago de Compostela, Santiago de Compostela, , Spain
University Hospital La Fe, Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa de Zaragoza, Zaragoza, , Spain
Kaohsiung Medical University Hospital, Kaohsiung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital- Linkou Branch, Taoyuan, , Taiwan
Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom
Addenbrooke's Hospital, Cambridge, , United Kingdom
St Bartholomew's Hospital, London, , United Kingdom
Guy's Hospital - Guy's & St Thomas' NHS Foundation Trust, London, , United Kingdom
Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, , United Kingdom
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR