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
Start Date
9/18/2023
Completion Date
4/19/2033
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 Criteria
Age Range: 18 years to No maximum
Interventions
Linvoseltamab
Elotuzumab
Pomalidomide
Dexamethasone
Conditions
Locations
University of California Los Angeles (UCLA)
Los Angeles, California 90095
United States
University of Florida Division of Sponsored Programs
Gainesville, Florida 32611
United States
University of Kentucky, Markey Cancer Center Clinical Research Organization
Lexington, Kentucky 40536
United States
Norton Cancer Institute
Louisville, Kentucky 40207
United States
Stony Brook University
Stony Brook, New York 11794
United States
Levine Cancer Center
Charlotte, North Carolina 28204
United States
Duke University Medical Center
Durham, North Carolina 27705
United States
Kaiser Permanente Northwest
Portland, Oregon 97227
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
University of Washington
Seattle, Washington 98195
United States
Royal Prince Alfred Hospital
Camperdown, New South Wales 2050
Australia
Royal North Shore Hospital
St Leonards, New South Wales 2065
Australia
Icon Cancer Centre - Wesley
Auchenflower, Queensland 4066
Australia
Royal Brisbane and Women's Hospital
Herston, Queensland 4029
Australia
Royal Adelaide Hospital
Adelaide, South Australia 5000
Australia
Royal Hobart Hospital
Hobart, Tasmania 7000
Australia
Launceston General Hospital
Launceston, Tasmania 7250
Australia
St Vincent's Hospital
Fitzroy, Victoria 3065
Australia
University Hospital Geelong
Geelong, Victoria 3220
Australia
Austin Hospital
Heidelberg, Victoria 3084
Australia
One Clinical Research at Hollywood Private Hospital
Nedlands, Western Australia 6009
Australia
Clinique Universitaire de Mont Godinne
Yvoir, Namur 5530
Belgium
AZ Delta Algemeen Ziekenhuis Delta
Roeselare, West-Vlaanderen 8800
Belgium
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, 2060
Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200
Belgium
IDOR - Sao Rafael Salvador Bahia
Salvador, Estado de Bahia 41253-190
Brazil
Hospital Erasto Gaertner
Curitiba, Paraná 81520-060
Brazil
Associacao Dr Bartholomeu Tacchini
Bento Gonçalves, Rio Grande do Sul 95700-084
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul 90035-903
Brazil
Centro Gaucho Integrado
Porto Alegre, Rio Grande do Sul 90110-270
Brazil
Animi Unidade de Tratamento Oncologico
Lages, Santa Catarina 88501-001
Brazil
Instituto Americas de Ensino e Pesquisa
Rio de Janeiro, 22793-080
Brazil
A Beneficencia Portuguesa de Sao Paulo, Oncology House
São Paulo, 01321000
Brazil
Instituto DOr de Pesquisa e Ensino
São Paulo, 01401-002
Brazil
AC Camargo Cancer Center
São Paulo, 01509-010
Brazil
Clinica Medica Sao Germano
São Paulo, 04537-080
Brazil
The Ottawa Hospital Cancer Centre
Ottawa, Ontario K1H 8L6
Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
Canada
University Health Network-Princess Margaret Cancer Center
Toronto, Ontario M5G 2M9
Canada
Hospital Clinico Universidad de Los Andes
Santiago, Las Condes 7620157
Chile
Clinica Alemana de Santiago
Santiago, Santiago Metropolitan 6681920
Chile
Fundacion Arturo Lopez Perez
Santiago, Santiago Metropolitan 7500921
Chile
Clinica UC San Carlos de Apoquindo
Santiago, Santiago Metropolitan 7550000
Chile
Centro Oncologia de Precision Universidad Mayor
Santiago, Santiago Metropolitan 7560907
Chile
Centro de Investigaciones Clinicas Vina del Mar
Viña del Mar, Valparaiso 2540488
Chile
Centre Leon Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)
Lyon, Auvergne-Rhone 69008
France
Centre Francois Magendie
Pessac, Gironde 33600
France
Centre Hospitalier Universitaire de Lille
Lille, Hauts-de-France 59037
France
Hopital Saint Louis, APHP
Paris, 75010
France
Saint Antoine Hospital
Paris, 75571
France
Institut Curie
Saint-Cloud, 92210
France
Hopital Necker
Paris, Île-de-France Region 75015
France
Gustave Roussy
Villejuif, Île-de-France Region 94800
France
Medical Clinic II
Tübingen, Baden-Wurttemberg 72076
Germany
Universitat zu Lubeck Neuromuskulares Zentrum
Lübeck, Ratzeburger 23538
Germany
University Hospital Hamburg Eppendorf
Hamburg, 20246
Germany
University Hospital Leipzig - Hematology and Cellular Therapy
Leipzig, 4103
Germany
Rambam Health Care Campus
Haifa, North 3109601
Israel
Lady Davis Carmel Medical Center
Haifa, 3436212
Israel
Shaare Zedek Medical Center
Jerusalem, 9103102
Israel
Hadassah Medical Center
Jerusalem, 91120
Israel
Sheba Medical Center
Ramat Gan, 52621
Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Israel
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia 71013
Italy
Istituto Romagnolo per lo Studio Dei Tumori Dino Amadori
Meldola, Forli-Cesena 47014
Italy
Ospedale Policlinico San Martino IRCCS
Genoa, Genova 16132
Italy
Azienda Ospedaliera Nazionale SS - Antonio e Biagio e Cesare Arrigo
Alessandria, Piedmont 15121
Italy
A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont 10126
Italy
IRCCS Fondazione Piemontese Oncologica Candiolo
Candiolo, Torino 10060
Italy
AOU Ospedali Riuniti di Ancona
Ancona, 60126
Italy
Policlinico S. Orsola- Malpighi
Bologna, 40138
Italy
Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
Catania, 95123
Italy
Universita degli Studi di Pavia - Fondazione IRCCS Policlini
Pavia, 27100
Italy
Ospedale Santa Maria delle Croci
Ravenna, 48121
Italy
AUSL IRCCS OF Reggio Emilia - Clinical Study Location -
Reggio Emilia, 42123
Italy
Ospedale di Circolo e Fondazione Macchi Varese
Varese, 21100
Italy
Aichi Medial University Hospital
Nagakute, Aichi-ken 480-1195
Japan
Chiba Cancer Center
Chiba, Chiba 260-8717
Japan
Kameda General Hospital
Kamogawa, Chiba 296-8602
Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba 277-8577
Japan
Kurume University Hospital
Kurume, Fukuoka 830-0011
Japan
Ogaki Municipal Hospital
Ōgaki, Gifu 503-8502
Japan
Gunma University Hospital
Maebashi, Gunma 371-8511
Japan
NHO Shibukawa Medical Center
Shibukawa, Gunma 377-0280
Japan
Sapporo Hokuyu Hospital
Sapporo, Hokkaido 003-0006
Japan
Iwate Medical University Hospital
Yahaba, Iwate 028-3694
Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, Kumamoto 860-0008
Japan
National Hospital Organization Okayama Medical Center
Kita-ku, Okayama-ken 701-1192
Japan
Osaka University Hospital
Suita-shi, Osaka 565-0871
Japan
Saitama Medical University Hospital
Iruma-gun, Saitama 350-0495
Japan
Tokushima Prefectural Central Hospital
Tokushima, Tokushima 770-8539
Japan
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo 150-8935
Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi 400-8506
Japan
Fukushima Medical University
Fukushima, 960-1295
Japan
National Hospital Organization Sendai Medical Center
Sendai, 983-8520
Japan
Radboudumc
Nijmegen, Gelderland 6500HB
Netherlands
Albert Schweitzer Hospital
Dordrecht, South Holland 3318 AT
Netherlands
University Clinical Center / Medical University of Gdansk
Gdansk, Pomeranian Voivodeship 80-219
Poland
Szpital Uniwersytecki Nr2 Bydgoszcz
Bydgoszcz, 85-168
Poland
Pratia Onkologia Katowice
Katowice, 40-519
Poland
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-954
Poland
Wielospecjalistyczne Centrum Onkologii i Traumatologii
Lodz, Łódź Voivodeship 93-510
Poland
National University Hospital
Singapore, 119074
Singapore
Singapore General Hospital
Singapore, 169608
Singapore
Gachon University Gil Hospital
Incheon, Gyeonggi-do 21565
South Korea
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do 54907
South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do 58128
South Korea
Inje University Busan Paik Hospital
Busan, 47392
South Korea
Pusan National University Hospital
Busan, 49241
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Seoul St Marys Hospital
Seoul, 137-701
South Korea
Samsung Medical Center
Seoul, 6351
South Korea
Seoul National University Hospital
Seoul, 744
South Korea
Severance Hospital
Seoul, 82
South Korea
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna 15706
Spain
Hospital Universitario Araba
Vitoria-Gasteiz, Alava 01009
Spain
Hospital Universitari Son Espases
Palma, Balearic Islands 07120
Spain
Hospital Universitari Son Llatzer
Palma Mallorca, Balearic Islands 07198
Spain
Institut Catala d'Oncologia
Badalona, Barcelona 08916
Spain
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona 08221
Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
Spain
Complejo Asistencial Universitario de Leon
León, Castille and León 24070
Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid 28222
Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid 28223
Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, Navarre 31008
Spain
Hospital Universitario de Navarra
Pamplona, Navarre 31008
Spain
University Hospital of Cabuenes
Gijón, Principality of Asturias 33203
Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias 33011
Spain
Universitary Hospital La Princesa
Madrid, Salamanca 28006
Spain
Hospital General Universitario Doctor Balmis Alicante
Alicante, Valencia 03010
Spain
Hospital Clinic de Barcelona
Barcelona, 08036
Spain
Hospital Sant Pau
Barcelona, 08041
Spain
Catalan Institute of Oncology (ICO) Hospitalet
Barcelona, 08908
Spain
Instituto Catalan Oncologia
Girona, 17007
Spain
Clinica Universidad de Navarra - Madrid
Madrid, 28027
Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
Hospital Virgen de la Victoria
Málaga, 29010
Spain
Hospital Universitario Virgen de Valme
Seville, 41014
Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Spain
Hospital Clinico Lozano Blesa
Zaragoza, 50009
Spain
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan, Hunan Province 33305
Taiwan
Changhua Christian Hospital
Changhua, 50006
Taiwan
Hualien Tzu Chi Hospital
Hualien City, 97002
Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, 80756
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Taiwan
Taichung Veterans General Hospital
Taichung, 40705
Taiwan
National Cheng Kung University Hospital
Tainan, 701
Taiwan
Wanfang Hospital
Taipei, 00116
Taiwan
National Taiwan University Hospital
Taipei, 10002
Taiwan
Tri-Service General Hospital
Taipei, 11490
Taiwan
Addenbrooke's Hospital
Cambridge, Cambrigeshire CB2 0QQ
United Kingdom
Western General Hospital
Edinburgh, Scotland EH4 2XU
United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands B15 2TH
United Kingdom
Barts Health NHS Trust
London, EC1A 7BE
United Kingdom
Guy's & St Thomas' NHS Foundation Trust
London, SE1 9RT
United Kingdom
Royal Marsden Hospital
London, SW7 3RP
United Kingdom
Hammersmith Hospital
London, W12 0HS
United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX
United Kingdom