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)

Status: Recruiting
Location: See all (158) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California Los Angeles (UCLA)
ACTIVE_NOT_RECRUITING
Los Angeles
Florida
University of Florida Division of Sponsored Programs
WITHDRAWN
Gainesville
Kentucky
University of Kentucky, Markey Cancer Center Clinical Research Organization
ACTIVE_NOT_RECRUITING
Lexington
Norton Cancer Institute
ACTIVE_NOT_RECRUITING
Louisville
North Carolina
Levine Cancer Center
ACTIVE_NOT_RECRUITING
Charlotte
Duke University Medical Center
WITHDRAWN
Durham
New York
Stony Brook University
ACTIVE_NOT_RECRUITING
Stony Brook
Oregon
Kaiser Permanente Northwest
ACTIVE_NOT_RECRUITING
Portland
Texas
MD Anderson Cancer Center
ACTIVE_NOT_RECRUITING
Houston
Washington
University of Washington
ACTIVE_NOT_RECRUITING
Seattle
Other Locations
Australia
Royal Adelaide Hospital
ACTIVE_NOT_RECRUITING
Adelaide
Icon Cancer Centre - Wesley
ACTIVE_NOT_RECRUITING
Auchenflower
Royal Prince Alfred Hospital
ACTIVE_NOT_RECRUITING
Camperdown
St Vincent's Hospital
ACTIVE_NOT_RECRUITING
Fitzroy
University Hospital Geelong
ACTIVE_NOT_RECRUITING
Geelong
Austin Hospital
ACTIVE_NOT_RECRUITING
Heidelberg
Royal Brisbane and Women's Hospital
ACTIVE_NOT_RECRUITING
Herston
Royal Hobart Hospital
ACTIVE_NOT_RECRUITING
Hobart
Launceston General Hospital
ACTIVE_NOT_RECRUITING
Launceston
One Clinical Research at Hollywood Private Hospital
ACTIVE_NOT_RECRUITING
Nedlands
Royal North Shore Hospital
ACTIVE_NOT_RECRUITING
St Leonards
Belgium
Ziekenhuis Netwerk Antwerpen Stuivenberg
ACTIVE_NOT_RECRUITING
Antwerp
Cliniques Universitaires Saint-Luc
WITHDRAWN
Brussels
AZ Delta Algemeen Ziekenhuis Delta
ACTIVE_NOT_RECRUITING
Roeselare
Clinique Universitaire de Mont Godinne
RECRUITING
Yvoir
Brazil
Associacao Dr Bartholomeu Tacchini
ACTIVE_NOT_RECRUITING
Bento Gonçalves
Animi Unidade de Tratamento Oncologico
ACTIVE_NOT_RECRUITING
Centro
Hospital Erasto Gaertner
ACTIVE_NOT_RECRUITING
Curitiba
Centro Gaucho Integrado
ACTIVE_NOT_RECRUITING
Porto Alegre
Hospital de Clinicas de Porto Alegre
ACTIVE_NOT_RECRUITING
Porto Alegre
Instituto Americas de Ensino e Pesquisa
ACTIVE_NOT_RECRUITING
Rio De Janeiro
IDOR - Sao Rafael Salvador Bahia
ACTIVE_NOT_RECRUITING
Salvador
AC Camargo Cancer Center
ACTIVE_NOT_RECRUITING
São Paulo
Clinica Medica Sao Germano
ACTIVE_NOT_RECRUITING
São Paulo
Hospital A Beneficencia Portuguesa de Sao Paulo
ACTIVE_NOT_RECRUITING
São Paulo
Instituto DOr de Pesquisa e Ensino
ACTIVE_NOT_RECRUITING
São Paulo
Canada
The Ottawa Hospital Cancer Centre
ACTIVE_NOT_RECRUITING
Ottawa
Sunnybrook Health Sciences Centre
ACTIVE_NOT_RECRUITING
Toronto
University Health Network-Princess Margaret Cancer Center
ACTIVE_NOT_RECRUITING
Toronto
Chile
Centro Oncologia de Precision Universidad Mayor
ACTIVE_NOT_RECRUITING
Santiago
Clinica Alemana de Santiago
ACTIVE_NOT_RECRUITING
Santiago
Clinica UC San Carlos de Apoquindo
ACTIVE_NOT_RECRUITING
Santiago
Fundacion Arturo Lopez Perez
ACTIVE_NOT_RECRUITING
Santiago
Hospital Clinico Universidad de Los Andes
ACTIVE_NOT_RECRUITING
Santiago
Centro de Investigaciones Clinicas Vina del Mar
ACTIVE_NOT_RECRUITING
Viña Del Mar
France
Centre Hospitalier Universitaire de Lille
SUSPENDED
Lille
Centre Leon Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)
ACTIVE_NOT_RECRUITING
Lyon
Hopital Necker
ACTIVE_NOT_RECRUITING
Paris
Hopital Saint Antoine
WITHDRAWN
Paris
Hopital Saint Louis, APHP
WITHDRAWN
Paris
Centre Francois Magendie
ACTIVE_NOT_RECRUITING
Pessac
Institut Curie
WITHDRAWN
Saint-cloud
Gustave Roussy
ACTIVE_NOT_RECRUITING
Villejuif
Germany
University Hospital Hamburg Eppendorf
ACTIVE_NOT_RECRUITING
Hamburg
University Hospital Leipzig - Hematology and Cellular Therapy
WITHDRAWN
Leipzig
Universitat zu Lubeck Neuromuskulares Zentrum
ACTIVE_NOT_RECRUITING
Lübeck
Medical Clinic II
ACTIVE_NOT_RECRUITING
Tübingen
Israel
Lady Davis Carmel Medical Center
ACTIVE_NOT_RECRUITING
Haifa
Rambam Health Care Campus
ACTIVE_NOT_RECRUITING
Haifa
Hadassah Medical Center
ACTIVE_NOT_RECRUITING
Jerusalem
Shaare Zedek Medical Center
ACTIVE_NOT_RECRUITING
Jerusalem
Sheba Medical Center
ACTIVE_NOT_RECRUITING
Ramat Gan
The Tel Aviv Sourasky Medical Center
ACTIVE_NOT_RECRUITING
Tel Aviv
Italy
Azienda Ospedaliera Nazionale SS - Antonio e Biagio e Cesare Arrigo
ACTIVE_NOT_RECRUITING
Alessandria
AOU Ospedali Riuniti di Ancona
ACTIVE_NOT_RECRUITING
Ancona
Policlinico S. Orsola- Malpighi
WITHDRAWN
Bologna
IRCCS Fondazione Piemontese Oncologica Candiolo
ACTIVE_NOT_RECRUITING
Candiolo
Azienda Ospedaliero Universitaria Policlinico G. Rodolico - San Marco
ACTIVE_NOT_RECRUITING
Catania
Ospedale Policlinico San Martino IRCCS
ACTIVE_NOT_RECRUITING
Genoa
Istituto Romagnolo per lo Studio Dei Tumori Dino Amadori
ACTIVE_NOT_RECRUITING
Meldola
Universita degli Studi di Pavia - Fondazione IRCCS Policlini
ACTIVE_NOT_RECRUITING
Pavia
Ospedale Santa Maria delle Croci
ACTIVE_NOT_RECRUITING
Ravenna
AUSL IRCCS OF Reggio Emilia - Clinical Study Location -
ACTIVE_NOT_RECRUITING
Reggio Emilia
IRCCS Casa Sollievo della Sofferenza
ACTIVE_NOT_RECRUITING
San Giovanni Rotondo
A.O.U. Citta della Salute e della Scienza di Torino
ACTIVE_NOT_RECRUITING
Turin
Ospedale di Circolo e Fondazione Macchi Varese
ACTIVE_NOT_RECRUITING
Varese
Japan
Chiba Cancer Center
RECRUITING
Chiba
Fukushima Medical University
RECRUITING
Fukushima
Saitama Medical University Hospital
RECRUITING
Iruma-gun
Kameda General Hospital
RECRUITING
Kamogawa
National Hospital Organization Okayama Medical Center
RECRUITING
Kita-ku
Yamanashi Prefectural Central Hospital
RECRUITING
Kofu
National Hospital Organization Kumamoto Medical Center
RECRUITING
Kumamoto
Kurume University Hospital
RECRUITING
Kurume
Gunma University Hospital
RECRUITING
Maebashi
Aichi Medial University Hospital
RECRUITING
Nagakute
Ogaki Municipal Hospital
RECRUITING
Ōgaki
Sapporo Hokuyu Hospital
RECRUITING
Sapporo
National Hospital Organization Sendai Medical Center
RECRUITING
Sendai
NHO Shibukawa Medical Center
RECRUITING
Shibukawa
Japanese Red Cross Medical Center
RECRUITING
Shibuya-ku
Osaka University Hospital
RECRUITING
Suita-shi
Tokushima Prefectural Central Hospital
RECRUITING
Tokushima
Iwate Medical University Hospital
RECRUITING
Yahaba
Netherlands
Albert Schweitzer Hospital
ACTIVE_NOT_RECRUITING
Dordrecht
Radboudumc
ACTIVE_NOT_RECRUITING
Nijmegen
Poland
Szpital Uniwersytecki Nr2 Bydgoszcz
ACTIVE_NOT_RECRUITING
Bydgoszcz
University Clinical Center / Medical University of Gdansk
ACTIVE_NOT_RECRUITING
Gdansk
Pratia Onkologia Katowice
ACTIVE_NOT_RECRUITING
Katowice
Wielospecjalistyczne Centrum Onkologii i Traumatologii
ACTIVE_NOT_RECRUITING
Lodz
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
ACTIVE_NOT_RECRUITING
Lublin
Republic of Korea
Inje University Busan Paik Hospital
ACTIVE_NOT_RECRUITING
Busan
Pusan National University Hospital
ACTIVE_NOT_RECRUITING
Busan
Chonnam National University Hwasun Hospital
ACTIVE_NOT_RECRUITING
Hwasun
Gachon University Gil Hospital
ACTIVE_NOT_RECRUITING
Incheon
Jeonbuk National University Hospital
ACTIVE_NOT_RECRUITING
Jeonju
Asan Medical Center
ACTIVE_NOT_RECRUITING
Seoul
Samsung Medical Center
ACTIVE_NOT_RECRUITING
Seoul
Seoul National University Hospital
ACTIVE_NOT_RECRUITING
Seoul
Seoul St Marys Hospital
ACTIVE_NOT_RECRUITING
Seoul
Severance Hospital
ACTIVE_NOT_RECRUITING
Seoul
Singapore
National University Hospital
ACTIVE_NOT_RECRUITING
Singapore
Singapore General Hospital
ACTIVE_NOT_RECRUITING
Singapore
Spain
Hospital General Universitario Doctor Balmis Alicante
ACTIVE_NOT_RECRUITING
Alicante
Institut Catala d'Oncologia
ACTIVE_NOT_RECRUITING
Badalona
Catalan Institute of Oncology (ICO) Hospitalet
RECRUITING
Barcelona
Hospital Clinic de Barcelona
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Sant Pau
WITHDRAWN
Barcelona
University Hospital of Cabuenes
ACTIVE_NOT_RECRUITING
Gijón
Instituto Catalan Oncologia
ACTIVE_NOT_RECRUITING
Girona
Complejo Asistencial Universitario de Leon
ACTIVE_NOT_RECRUITING
León
Clinica Universidad de Navarra - Madrid
WITHDRAWN
Madrid
Hospital Universitario Fundacion Jimenez Diaz
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario La Paz
ACTIVE_NOT_RECRUITING
Madrid
Universitary Hospital La Princesa
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro
WITHDRAWN
Majadahonda
Hospital Virgen de la Victoria
ACTIVE_NOT_RECRUITING
Málaga
Hospital Universitario Central de Asturias
WITHDRAWN
Oviedo
Hospital Universitari Son Espases
ACTIVE_NOT_RECRUITING
Palma
Hospital Universitari Son Llatzer
ACTIVE_NOT_RECRUITING
Palma Mallorca
Clinica Universidad de Navarra - Pamplona
WITHDRAWN
Pamplona
Hospital Universitario de Navarra
ACTIVE_NOT_RECRUITING
Pamplona
Hospital Universitario Quironsalud Madrid
ACTIVE_NOT_RECRUITING
Pozuelo De Alarcón
Hospital Universitario Marques de Valdecilla
ACTIVE_NOT_RECRUITING
Santander
Hospital Clinico Universitario Santiago de Compostela
WITHDRAWN
Santiago De Compostela
Hospital Universitario Virgen de Valme
ACTIVE_NOT_RECRUITING
Seville
Hospital Universitari Mutua Terrassa
ACTIVE_NOT_RECRUITING
Terrassa
Hospital Universitari i Politecnic La Fe
WITHDRAWN
Valencia
Hospital Universitario Araba
ACTIVE_NOT_RECRUITING
Vitoria-gasteiz
Hospital Clinico Lozano Blesa
ACTIVE_NOT_RECRUITING
Zaragoza
Taiwan
Changhua Christian Hospital
ACTIVE_NOT_RECRUITING
Changhua
Hualien Tzu Chi Hospital
ACTIVE_NOT_RECRUITING
Hualien City
Kaohsiung Chang Gung Memorial Hospital
ACTIVE_NOT_RECRUITING
Kaohsiung City
Kaohsiung Medical University Hospital
ACTIVE_NOT_RECRUITING
Kaohsiung City
Taichung Veterans General Hospital
WITHDRAWN
Taichung
National Cheng Kung University Hospital
ACTIVE_NOT_RECRUITING
Tainan City
National Taiwan University Hospital
ACTIVE_NOT_RECRUITING
Taipei
Tri-Service General Hospital
ACTIVE_NOT_RECRUITING
Taipei
Wanfang Hospital
ACTIVE_NOT_RECRUITING
Taipei
Chang Gung Memorial Hospital - Linkou Branch
ACTIVE_NOT_RECRUITING
Taoyuan District
United Kingdom
Queen Elizabeth Hospital Birmingham
ACTIVE_NOT_RECRUITING
Birmingham
Addenbrooke's Hospital
ACTIVE_NOT_RECRUITING
Cambridge
Western General Hospital
ACTIVE_NOT_RECRUITING
Edinburgh
Barts Health NHS Trust
ACTIVE_NOT_RECRUITING
London
Guy's & St Thomas' NHS Foundation Trust
ACTIVE_NOT_RECRUITING
London
Hammersmith Hospital
ACTIVE_NOT_RECRUITING
London
Royal Marsden Hospital
ACTIVE_NOT_RECRUITING
London
The Christie NHS Foundation Trust
WITHDRAWN
Manchester
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2023-09-18
Estimated Completion Date: 2033-04-19
Participants
Target number of participants: 410
Treatments
Experimental: Linvoseltamab
Randomization 1:1
Active_comparator: Elotuzumab/Pomalidomide/Dexamethasone (EPd)
Randomization 1:1
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov

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