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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Trial Management

Affiliation: Regeneron Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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