Actively Recruiting
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
Led by Regeneron Pharmaceuticals · Updated on 2026-03-06
410
Participants Needed
159
Research Sites
500 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older (or legal adult age in the country) at the time of screening.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; ECOG 2 allowed if due to myeloma symptoms after Medical Monitor discussion.
- Received 1 to 4 prior lines of anti-myeloma therapy including lenalidomide and a proteasome inhibitor with disease progression per 2016 IMWG criteria.
- Participants with only 1 prior therapy must be lenalidomide refractory.
- Participants in Israel must have also received a CD38 antibody; participants in EU and UK must have received 2 to 4 prior lines including a CD38 antibody.
- Measurable disease for response assessment per 2016 IMWG criteria.
- Adequate blood, liver, kidney, and heart function and corrected calcium within 7 days before randomization.
- Life expectancy of at least 6 months.
You will not qualify if you...
- Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome.
- Prior treatment with elotuzumab and/or pomalidomide.
- Known multiple myeloma brain lesions or meningeal involvement.
- Treatment with any systemic anti-cancer therapy within 5 half-lives or 28 days before study drug.
- History of allogeneic stem cell transplant within 6 months or autologous transplant within 12 weeks before study.
- Participants with allogeneic transplant must be off immunosuppressants for 6 weeks without graft-versus-host disease.
- Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies (BCMA antibody-drug conjugates allowed).
- History or suspicion of progressive multifocal leukoencephalopathy (PML) or neurocognitive/CNS movement disorders.
- Infection requiring hospitalization or IV anti-infective treatment within 2 weeks before study drug.
- Uncontrolled infection with HIV, hepatitis B or C, or other uncontrolled infection.
- Cardiac ejection fraction less than 40%.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 159 locations
1
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095
Active, Not Recruiting
2
University of Florida Division of Sponsored Programs
Gainesville, Florida, United States, 32611
Withdrawn
3
University of Kentucky, Markey Cancer Center Clinical Research Organization
Lexington, Kentucky, United States, 40536
Active, Not Recruiting
4
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
Active, Not Recruiting
5
Stony Brook University
Stony Brook, New York, United States, 11794
Active, Not Recruiting
6
Levine Cancer Center
Charlotte, North Carolina, United States, 28204
Active, Not Recruiting
7
Duke University Medical Center
Durham, North Carolina, United States, 27705
Withdrawn
8
Kaiser Permanente Northwest
Portland, Oregon, United States, 97227
Active, Not Recruiting
9
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Active, Not Recruiting
10
University of Washington
Seattle, Washington, United States, 98195
Active, Not Recruiting
11
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Active, Not Recruiting
12
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Active, Not Recruiting
13
Icon Cancer Centre - Wesley
Auchenflower, Queensland, Australia, 4066
Active, Not Recruiting
14
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Active, Not Recruiting
15
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Active, Not Recruiting
16
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Active, Not Recruiting
17
Launceston General Hospital
Launceston, Tasmania, Australia, 7250
Active, Not Recruiting
18
St Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
Active, Not Recruiting
19
University Hospital Geelong
Geelong, Victoria, Australia, 3220
Active, Not Recruiting
20
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Active, Not Recruiting
21
One Clinical Research at Hollywood Private Hospital
Nedlands, Western Australia, Australia, 6009
Active, Not Recruiting
22
Clinique Universitaire de Mont Godinne
Yvoir, Namur, Belgium, 5530
Completed
23
AZ Delta Algemeen Ziekenhuis Delta
Roeselare, West-Vlaanderen, Belgium, 8800
Active, Not Recruiting
24
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, Belgium, 2060
Active, Not Recruiting
25
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Withdrawn
26
IDOR - Sao Rafael Salvador Bahia
Salvador, Estado de Bahia, Brazil, 41253-190
Active, Not Recruiting
27
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil, 81520-060
Active, Not Recruiting
28
Associacao Dr Bartholomeu Tacchini
Bento Gonçalves, Rio Grande do Sul, Brazil, 95700-084
Active, Not Recruiting
29
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Active, Not Recruiting
30
Centro Gaucho Integrado
Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
Active, Not Recruiting
31
Animi Unidade de Tratamento Oncologico
Lages, Santa Catarina, Brazil, 88501-001
Active, Not Recruiting
32
Instituto Americas de Ensino e Pesquisa
Rio de Janeiro, Brazil, 22793-080
Active, Not Recruiting
33
A Beneficencia Portuguesa de Sao Paulo, Oncology House
São Paulo, Brazil, 01321000
Active, Not Recruiting
34
Instituto DOr de Pesquisa e Ensino
São Paulo, Brazil, 01401-002
Active, Not Recruiting
35
AC Camargo Cancer Center
São Paulo, Brazil, 01509-010
Active, Not Recruiting
36
Clinica Medica Sao Germano
São Paulo, Brazil, 04537-080
Active, Not Recruiting
37
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Active, Not Recruiting
38
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Active, Not Recruiting
39
University Health Network-Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 2M9
Active, Not Recruiting
40
Hospital Clinico Universidad de Los Andes
Santiago, Las Condes, Chile, 7620157
Active, Not Recruiting
41
Clinica Alemana de Santiago
Santiago, Santiago Metropolitan, Chile, 6681920
Active, Not Recruiting
42
Fundacion Arturo Lopez Perez
Santiago, Santiago Metropolitan, Chile, 7500921
Active, Not Recruiting
43
Clinica UC San Carlos de Apoquindo
Santiago, Santiago Metropolitan, Chile, 7550000
Active, Not Recruiting
44
Centro Oncologia de Precision Universidad Mayor
Santiago, Santiago Metropolitan, Chile, 7560907
Active, Not Recruiting
45
Centro de Investigaciones Clinicas Vina del Mar
Viña del Mar, Valparaiso, Chile, 2540488
Active, Not Recruiting
46
Centre Leon Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)
Lyon, Auvergne-Rhone, France, 69008
Active, Not Recruiting
47
Centre Francois Magendie
Pessac, Gironde, France, 33600
Active, Not Recruiting
48
Centre Hospitalier Universitaire de Lille
Lille, Hauts-de-France, France, 59037
Withdrawn
49
Hopital Saint Louis, APHP
Paris, France, 75010
Completed
50
Saint Antoine Hospital
Paris, France, 75571
Completed
51
Institut Curie
Saint-Cloud, France, 92210
Completed
52
Hopital Necker
Paris, Île-de-France Region, France, 75015
Active, Not Recruiting
53
Gustave Roussy
Villejuif, Île-de-France Region, France, 94800
Active, Not Recruiting
54
Medical Clinic II
Tübingen, Baden-Wurttemberg, Germany, 72076
Active, Not Recruiting
55
Universitat zu Lubeck Neuromuskulares Zentrum
Lübeck, Ratzeburger, Germany, 23538
Active, Not Recruiting
56
University Hospital Hamburg Eppendorf
Hamburg, Germany, 20246
Active, Not Recruiting
57
University Hospital Leipzig - Hematology and Cellular Therapy
Leipzig, Germany, 4103
Withdrawn
58
Rambam Health Care Campus
Haifa, North, Israel, 3109601
Active, Not Recruiting
59
Lady Davis Carmel Medical Center
Haifa, Israel, 3436212
Active, Not Recruiting
60
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Active, Not Recruiting
61
Hadassah Medical Center
Jerusalem, Israel, 91120
Active, Not Recruiting
62
Sheba Medical Center
Ramat Gan, Israel, 52621
Active, Not Recruiting
63
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Active, Not Recruiting
64
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy, 71013
Active, Not Recruiting
65
Istituto Romagnolo per lo Studio Dei Tumori Dino Amadori
Meldola, Forli-Cesena, Italy, 47014
Active, Not Recruiting
66
Ospedale Policlinico San Martino IRCCS
Genoa, Genova, Italy, 16132
Active, Not Recruiting
67
Azienda Ospedaliera Nazionale SS - Antonio e Biagio e Cesare Arrigo
Alessandria, Piedmont, Italy, 15121
Active, Not Recruiting
68
A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont, Italy, 10126
Active, Not Recruiting
69
IRCCS Fondazione Piemontese Oncologica Candiolo
Candiolo, Torino, Italy, 10060
Active, Not Recruiting
70
AOU Ospedali Riuniti di Ancona
Ancona, Italy, 60126
Active, Not Recruiting
71
Policlinico S. Orsola- Malpighi
Bologna, Italy, 40138
Withdrawn
72
Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
Catania, Italy, 95123
Active, Not Recruiting
73
Universita degli Studi di Pavia - Fondazione IRCCS Policlini
Pavia, Italy, 27100
Active, Not Recruiting
74
Ospedale Santa Maria delle Croci
Ravenna, Italy, 48121
Active, Not Recruiting
75
AUSL IRCCS OF Reggio Emilia - Clinical Study Location -
Reggio Emilia, Italy, 42123
Active, Not Recruiting
76
Ospedale di Circolo e Fondazione Macchi Varese
Varese, Italy, 21100
Active, Not Recruiting
77
Aichi Medial University Hospital
Nagakute, Aichi-ken, Japan, 480-1195
Actively Recruiting
78
Chiba Cancer Center
Chiba, Chiba, Japan, 260-8717
Actively Recruiting
79
Kameda General Hospital
Kamogawa, Chiba, Japan, 296-8602
Actively Recruiting
80
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan, 277-8577
Actively Recruiting
81
Kurume University Hospital
Kurume, Fukuoka, Japan, 830-0011
Actively Recruiting
82
Ogaki Municipal Hospital
Ōgaki, Gifu, Japan, 503-8502
Actively Recruiting
83
Gunma University Hospital
Maebashi, Gunma, Japan, 371-8511
Actively Recruiting
84
NHO Shibukawa Medical Center
Shibukawa, Gunma, Japan, 377-0280
Actively Recruiting
85
Sapporo Hokuyu Hospital
Sapporo, Hokkaido, Japan, 003-0006
Actively Recruiting
86
Iwate Medical University Hospital
Yahaba, Iwate, Japan, 028-3694
Actively Recruiting
87
National Hospital Organization Kumamoto Medical Center
Kumamoto, Kumamoto, Japan, 860-0008
Actively Recruiting
88
National Hospital Organization Okayama Medical Center
Kita-ku, Okayama-ken, Japan, 701-1192
Actively Recruiting
89
Osaka University Hospital
Suita-shi, Osaka, Japan, 565-0871
Actively Recruiting
90
Saitama Medical University Hospital
Iruma-gun, Saitama, Japan, 350-0495
Actively Recruiting
91
Tokushima Prefectural Central Hospital
Tokushima, Tokushima, Japan, 770-8539
Actively Recruiting
92
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, Japan, 150-8935
Actively Recruiting
93
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan, 400-8506
Actively Recruiting
94
Fukushima Medical University
Fukushima, Japan, 960-1295
Actively Recruiting
95
National Hospital Organization Sendai Medical Center
Sendai, Japan, 983-8520
Actively Recruiting
96
Radboudumc
Nijmegen, Gelderland, Netherlands, 6500HB
Active, Not Recruiting
97
Albert Schweitzer Hospital
Dordrecht, South Holland, Netherlands, 3318 AT
Active, Not Recruiting
98
University Clinical Center / Medical University of Gdansk
Gdansk, Pomeranian Voivodeship, Poland, 80-219
Active, Not Recruiting
99
Szpital Uniwersytecki Nr2 Bydgoszcz
Bydgoszcz, Poland, 85-168
Completed
100
Pratia Onkologia Katowice
Katowice, Poland, 40-519
Active, Not Recruiting
101
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, Poland, 20-954
Active, Not Recruiting
102
Wielospecjalistyczne Centrum Onkologii i Traumatologii
Lodz, Łódź Voivodeship, Poland, 93-510
Active, Not Recruiting
103
National University Hospital
Singapore, Singapore, 119074
Active, Not Recruiting
104
Singapore General Hospital
Singapore, Singapore, 169608
Active, Not Recruiting
105
Gachon University Gil Hospital
Incheon, Gyeonggi-do, South Korea, 21565
Active, Not Recruiting
106
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea, 54907
Active, Not Recruiting
107
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea, 58128
Active, Not Recruiting
108
Inje University Busan Paik Hospital
Busan, South Korea, 47392
Active, Not Recruiting
109
Pusan National University Hospital
Busan, South Korea, 49241
Active, Not Recruiting
110
Asan Medical Center
Seoul, South Korea, 05505
Active, Not Recruiting
111
Seoul St Marys Hospital
Seoul, South Korea, 137-701
Active, Not Recruiting
112
Samsung Medical Center
Seoul, South Korea, 6351
Active, Not Recruiting
113
Seoul National University Hospital
Seoul, South Korea, 744
Active, Not Recruiting
114
Severance Hospital
Seoul, South Korea, 82
Active, Not Recruiting
115
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna, Spain, 15706
Withdrawn
116
Hospital Universitario Araba
Vitoria-Gasteiz, Alava, Spain, 01009
Active, Not Recruiting
117
Hospital Universitari Son Espases
Palma, Balearic Islands, Spain, 07120
Active, Not Recruiting
118
Hospital Universitari Son Llatzer
Palma Mallorca, Balearic Islands, Spain, 07198
Active, Not Recruiting
119
Institut Catala d'Oncologia
Badalona, Barcelona, Spain, 08916
Active, Not Recruiting
120
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, Spain, 08221
Active, Not Recruiting
121
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Active, Not Recruiting
122
Complejo Asistencial Universitario de Leon
León, Castille and León, Spain, 24070
Active, Not Recruiting
123
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Withdrawn
124
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain, 28223
Active, Not Recruiting
125
Clinica Universidad de Navarra - Pamplona
Pamplona, Navarre, Spain, 31008
Withdrawn
126
Hospital Universitario de Navarra
Pamplona, Navarre, Spain, 31008
Active, Not Recruiting
127
University Hospital of Cabuenes
Gijón, Principality of Asturias, Spain, 33203
Active, Not Recruiting
128
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Withdrawn
129
Universitary Hospital La Princesa
Madrid, Salamanca, Spain, 28006
Active, Not Recruiting
130
Hospital General Universitario Doctor Balmis Alicante
Alicante, Valencia, Spain, 03010
Active, Not Recruiting
131
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Active, Not Recruiting
132
Hospital Sant Pau
Barcelona, Spain, 08041
Withdrawn
133
Catalan Institute of Oncology (ICO) Hospitalet
Barcelona, Spain, 08908
Actively Recruiting
134
Instituto Catalan Oncologia
Girona, Spain, 17007
Active, Not Recruiting
135
Clinica Universidad de Navarra - Madrid
Madrid, Spain, 28027
Withdrawn
136
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Active, Not Recruiting
137
Hospital Universitario La Paz
Madrid, Spain, 28046
Active, Not Recruiting
138
Hospital Virgen de la Victoria
Málaga, Spain, 29010
Active, Not Recruiting
139
Hospital Universitario Virgen de Valme
Seville, Spain, 41014
Active, Not Recruiting
140
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Withdrawn
141
Hospital Clinico Lozano Blesa
Zaragoza, Spain, 50009
Active, Not Recruiting
142
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan, Hunan Province, Taiwan, 33305
Active, Not Recruiting
143
Changhua Christian Hospital
Changhua, Taiwan, 50006
Active, Not Recruiting
144
Hualien Tzu Chi Hospital
Hualien City, Taiwan, 97002
Active, Not Recruiting
145
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan, 80756
Active, Not Recruiting
146
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 83301
Active, Not Recruiting
147
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Withdrawn
148
National Cheng Kung University Hospital
Tainan, Taiwan, 701
Active, Not Recruiting
149
Wanfang Hospital
Taipei, Taiwan, 00116
Active, Not Recruiting
150
National Taiwan University Hospital
Taipei, Taiwan, 10002
Active, Not Recruiting
151
Tri-Service General Hospital
Taipei, Taiwan, 11490
Active, Not Recruiting
152
Addenbrooke's Hospital
Cambridge, Cambrigeshire, United Kingdom, CB2 0QQ
Active, Not Recruiting
153
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Active, Not Recruiting
154
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, United Kingdom, B15 2TH
Active, Not Recruiting
155
Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
Active, Not Recruiting
156
Guy's & St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Active, Not Recruiting
157
Royal Marsden Hospital
London, United Kingdom, SW7 3RP
Active, Not Recruiting
158
Hammersmith Hospital
London, United Kingdom, W12 0HS
Active, Not Recruiting
159
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Withdrawn
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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