Relapsed Refractory Multiple Myeloma (RRMM)Phase 3LINKER-MM3NCT05730036
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
A Phase 3 study testing Linvoseltamab, Elotuzumab and Pomalidomide in people with Relapsed Refractory Multiple Myeloma (RRMM), run by Regeneron Pharmaceuticals at 159 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Refractory Multiple Myeloma (RRMM)
- What is being tested?
- Linvoseltamab, Elotuzumab and Pomalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 159 sitesin 18 countries
- Study dates
- 18 Sep 2023to 19 Apr 2033
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- Prior treatment with elotuzumab and/or pomalidomide
- Participants with known MM brain lesions or meningeal involvement
- Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
- History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment. Participants who have received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Steroids at doses equivalent to suppletion doses may be acceptable.
- Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed.
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- History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder (Parkinson's disease or Parkinsonism).
- Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in the protocol 10 Cardiac ejection fraction <40%.
- NOTE: Other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
159 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
159 sites in 18 countries
Spain27 sites
- Active, not recruiting
Hospital General Universitario Doctor Balmis Alicante
Alicante, Valencia, 03010
- Active, not recruiting
Institut Catala d'Oncologia
Badalona, Barcelona, 08916
- Completed
Hospital Clinic de Barcelona
Barcelona, 08036
- Withdrawn
Hospital Sant Pau
Barcelona, 08041
- Withdrawn
Catalan Institute of Oncology (ICO) Hospitalet
Barcelona, 08908
- Active, not recruiting
University Hospital of Cabuenes
Gijón, Principality of Asturias, 33203
- Active, not recruiting
Instituto Catalan Oncologia
Girona, 17007
- Active, not recruiting
Complejo Asistencial Universitario de Leon
León, Castille and León, 24070
- Active, not recruiting
Universitary Hospital La Princesa
Madrid, Salamanca, 28006
- Withdrawn
Clinica Universidad de Navarra - Madrid
Madrid, 28027
- Active, not recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
- Active, not recruiting
Hospital Universitario La Paz
Madrid, 28046
- Withdrawn
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
- Active, not recruiting
Hospital Virgen de la Victoria
Málaga, 29010
- Withdrawn
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
- Active, not recruiting
Hospital Universitari Son Espases
Palma, Balearic Islands, 07120
- Active, not recruiting
Hospital Universitari Son Llatzer
Palma Mallorca, Balearic Islands, 07198
- Withdrawn
Clinica Universidad de Navarra - Pamplona
Pamplona, Navarre, 31008
- Active, not recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
- Active, not recruiting
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223
- Active, not recruiting
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
- Withdrawn
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna, 15706
- Active, not recruiting
Hospital Universitario Virgen de Valme
Seville, 41014
- Active, not recruiting
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, 08221
- Withdrawn
Hospital Universitari i Politecnic La Fe
Valencia, 46026
- Active, not recruiting
Hospital Universitario Araba
Vitoria-Gasteiz, Alava, 01009
- Active, not recruiting
Hospital Clinico Lozano Blesa
Zaragoza, 50009
Japan19 sites, 19 recruiting
- Recruiting
Chiba Cancer Center
Chiba, Chiba, 260-8717
- Recruiting
Fukushima Medical University
Fukushima, 960-1295
- Recruiting
Saitama Medical University Hospital
Iruma-gun, Saitama, 350-0495
- Recruiting
Kameda General Hospital
Kamogawa, Chiba, 296-8602
- Recruiting
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
- Recruiting
National Hospital Organization Okayama Medical Center
Kita-ku, Okayama-ken, 701-1192
- Recruiting
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, 400-8506
- Recruiting
National Hospital Organization Kumamoto Medical Center
Kumamoto, Kumamoto, 860-0008
- Recruiting
Kurume University Hospital
Kurume, Fukuoka, 830-0011
- Recruiting
Gunma University Hospital
Maebashi, Gunma, 371-8511
- Recruiting
Aichi Medial University Hospital
Nagakute, Aichi-ken, 480-1195
- Recruiting
Ogaki Municipal Hospital
Ōgaki, Gifu, 503-8502
- Recruiting
Sapporo Hokuyu Hospital
Sapporo, Hokkaido, 003-0006
- Recruiting
National Hospital Organization Sendai Medical Center
Sendai, 983-8520
- Recruiting
NHO Shibukawa Medical Center
Shibukawa, Gunma, 377-0280
- Recruiting
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, 150-8935
- Recruiting
Iwate Medical University Hospital
Shiwa-gun, Iwate, 028-3694
- Recruiting
Osaka University Hospital
Suita-shi, Osaka, 565-0871
- Recruiting
Tokushima Prefectural Central Hospital
Tokushima, Tokushima, 770-8539
Italy13 sites
- Active, not recruiting
Azienda Ospedaliera Nazionale SS - Antonio e Biagio e Cesare Arrigo
Alessandria, Piedmont, 15121
- Active, not recruiting
AOU Ospedali Riuniti di Ancona
Ancona, 60126
- Withdrawn
Policlinico S. Orsola- Malpighi
Bologna, 40138
- Active, not recruiting
IRCCS Fondazione Piemontese Oncologica Candiolo
Candiolo, Torino, 10060
- Active, not recruiting
Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
Catania, 95123
- Active, not recruiting
Ospedale Policlinico San Martino IRCCS
Genoa, Genova, 16132
- Active, not recruiting
Istituto Romagnolo per lo Studio Dei Tumori Dino Amadori
Meldola, Forli-Cesena, 47014
- Active, not recruiting
Universita degli Studi di Pavia - Fondazione IRCCS Policlini
Pavia, 27100
- Active, not recruiting
Ospedale Santa Maria delle Croci
Ravenna, 48121
- Active, not recruiting
AUSL IRCCS OF Reggio Emilia - Clinical Study Location -
Reggio Emilia, 42123
- Active, not recruiting
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013
- Active, not recruiting
A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont, 10126
- Active, not recruiting
Ospedale di Circolo e Fondazione Macchi Varese
Varese, 21100
Australia11 sites
- Active, not recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
- Active, not recruiting
Icon Cancer Centre - Wesley
Auchenflower, Queensland, 4066
- Active, not recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
- Active, not recruiting
St Vincent's Hospital
Fitzroy, Victoria, 3065
- Active, not recruiting
University Hospital Geelong
Geelong, Victoria, 3220
- Active, not recruiting
Austin Hospital
Heidelberg, Victoria, 3084
- Active, not recruiting
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
- Active, not recruiting
Royal Hobart Hospital
Hobart, Tasmania, 7000
- Active, not recruiting
Launceston General Hospital
Launceston, Tasmania, 7250
- Active, not recruiting
One Clinical Research at Hollywood Private Hospital
Nedlands, Western Australia, 6009
- Active, not recruiting
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Brazil11 sites
- Active, not recruiting
Associacao Dr Bartholomeu Tacchini
Bento Gonçalves, Rio Grande do Sul, 95700-084
- Active, not recruiting
Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060
- Active, not recruiting
Animi Unidade de Tratamento Oncologico
Lages, Santa Catarina, 88501-001
- Active, not recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
- Active, not recruiting
Centro Gaucho Integrado
Porto Alegre, Rio Grande do Sul, 90110-270
- Active, not recruiting
Instituto Americas de Ensino e Pesquisa
Rio de Janeiro, 22793-080
- Active, not recruiting
IDOR - Sao Rafael Salvador Bahia
Salvador, Estado de Bahia, 41253-190
- Active, not recruiting
A Beneficencia Portuguesa de Sao Paulo, Oncology House
São Paulo, 01321000
- Active, not recruiting
Instituto DOr de Pesquisa e Ensino
São Paulo, 01401-002
- Active, not recruiting
AC Camargo Cancer Center
São Paulo, 01509-010
- Active, not recruiting
Clinica Medica Sao Germano
São Paulo, 04537-080
United States10 sites
- Active, not recruiting
Levine Cancer Center
Charlotte, North Carolina, 28204
- Withdrawn
Duke University Medical Center
Durham, North Carolina, 27705
- Withdrawn
University of Florida Division of Sponsored Programs
Gainesville, Florida, 32611
- Active, not recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Active, not recruiting
University of Kentucky, Markey Cancer Center Clinical Research Organization
Lexington, Kentucky, 40536
- Active, not recruiting
University of California Los Angeles (UCLA)
Los Angeles, California, 90095
- Active, not recruiting
Norton Cancer Institute
Louisville, Kentucky, 40207
- Active, not recruiting
Kaiser Permanente Northwest
Portland, Oregon, 97227
- Active, not recruiting
University of Washington
Seattle, Washington, 98195
- Active, not recruiting
Stony Brook University
Stony Brook, New York, 11794
South Korea10 sites
- Active, not recruiting
Inje University Busan Paik Hospital
Busan, 47392
- Active, not recruiting
Pusan National University Hospital
Busan, 49241
- Active, not recruiting
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128
- Active, not recruiting
Gachon University Gil Hospital
Incheon, Gyeonggi-do, 21565
- Active, not recruiting
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
- Active, not recruiting
Asan Medical Center
Seoul, 05505
- Active, not recruiting
Seoul St Marys Hospital
Seoul, 137-701
- Active, not recruiting
Samsung Medical Center
Seoul, 6351
- Active, not recruiting
Seoul National University Hospital
Seoul, 744
- Active, not recruiting
Severance Hospital
Seoul, 82
Taiwan10 sites
- Active, not recruiting
Changhua Christian Hospital
Changhua, 50006
- Active, not recruiting
Hualien Tzu Chi Hospital
Hualien City, 97002
- Active, not recruiting
Kaohsiung Medical University Hospital
Kaohsiung City, 80756
- Active, not recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
- Withdrawn
Taichung Veterans General Hospital
Taichung, 40705
- Active, not recruiting
National Cheng Kung University Hospital
Tainan, 701
- Active, not recruiting
Wanfang Hospital
Taipei, 00116
- Active, not recruiting
National Taiwan University Hospital
Taipei, 10002
- Active, not recruiting
Tri-Service General Hospital
Taipei, 11490
- Active, not recruiting
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan, Hunan Province, 33305
France8 sites
- Withdrawn
Centre Hospitalier Universitaire de Lille
Lille, Hauts-de-France, 59037
- Active, not recruiting
Centre Leon Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)
Lyon, Auvergne-Rhone, 69008
- Completed
Hopital Saint Louis, APHP
Paris, 75010
- Completed
Saint Antoine Hospital
Paris, 75571
- Active, not recruiting
Hopital Necker
Paris, Île-de-France Region, 75015
- Active, not recruiting
Centre Francois Magendie
Pessac, Gironde, 33600
- Completed
Institut Curie
Saint-Cloud, 92210
- Active, not recruiting
Gustave Roussy
Villejuif, Île-de-France Region, 94800
United Kingdom8 sites
- Active, not recruiting
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, B15 2TH
- Active, not recruiting
Addenbrooke's Hospital
Cambridge, Cambrigeshire, CB2 0QQ
- Active, not recruiting
Western General Hospital
Edinburgh, Scotland, EH4 2XU
- Active, not recruiting
Barts Health NHS Trust
London, EC1A 7BE
- Active, not recruiting
Guy's & St Thomas' NHS Foundation Trust
London, SE1 9RT
- Active, not recruiting
Royal Marsden Hospital
London, SW7 3RP
- Active, not recruiting
Hammersmith Hospital
London, W12 0HS
- Withdrawn
The Christie NHS Foundation Trust
Manchester, M20 4BX
Chile6 sites
- Active, not recruiting
Hospital Clinico Universidad de Los Andes
Santiago, Las Condes, 7620157
- Active, not recruiting
Clinica Alemana de Santiago
Santiago, Santiago Metropolitan, 6681920
- Active, not recruiting
Fundacion Arturo Lopez Perez
Santiago, Santiago Metropolitan, 7500921
- Active, not recruiting
Clinica UC San Carlos de Apoquindo
Santiago, Santiago Metropolitan, 7550000
- Active, not recruiting
Centro Oncologia de Precision Universidad Mayor
Santiago, Santiago Metropolitan, 7560907
- Active, not recruiting
Centro de Investigaciones Clinicas Vina del Mar
Viña del Mar, Valparaiso, 2540488
Israel6 sites
- Active, not recruiting
Rambam Health Care Campus
Haifa, North, 3109601
- Active, not recruiting
Lady Davis Carmel Medical Center
Haifa, 3436212
- Active, not recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
- Active, not recruiting
Hadassah Medical Center
Jerusalem, 91120
- Active, not recruiting
Sheba Medical Center
Ramat Gan, 52621
- Active, not recruiting
The Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Poland5 sites
- Completed
Szpital Uniwersytecki Nr2 Bydgoszcz
Bydgoszcz, 85-168
- Active, not recruiting
University Clinical Center / Medical University of Gdansk
Gdansk, Pomeranian Voivodeship, 80-219
- Active, not recruiting
Pratia Onkologia Katowice
Katowice, 40-519
- Active, not recruiting
Wielospecjalistyczne Centrum Onkologii i Traumatologii
Lodz, Łódź Voivodeship, 93-510
- Completed
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-954
Belgium4 sites
- Active, not recruiting
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, 2060
- Withdrawn
Cliniques Universitaires Saint-Luc
Brussels, 1200
- Active, not recruiting
AZ Delta Algemeen Ziekenhuis Delta
Roeselare, West-Vlaanderen, 8800
- Completed
Clinique Universitaire de Mont Godinne
Yvoir, Namur, 5530
Germany4 sites
- Active, not recruiting
University Hospital Hamburg Eppendorf
Hamburg, 20246
- Withdrawn
University Hospital Leipzig - Hematology and Cellular Therapy
Leipzig, 4103
- Active, not recruiting
Universitat zu Lubeck Neuromuskulares Zentrum
Lübeck, Ratzeburger, 23538
- Completed
Medical Clinic II
Tübingen, Baden-Wurttemberg, 72076
Canada3 sites
- Active, not recruiting
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
- Active, not recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
- Active, not recruiting
University Health Network-Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
Netherlands2 sites
- Active, not recruiting
Albert Schweitzer Hospital
Dordrecht, South Holland, 3318 AT
- Active, not recruiting
Radboudumc
Nijmegen, Gelderland, 6500HB
Singapore2 sites
- Active, not recruiting
National University Hospital
Singapore, 119074
- Active, not recruiting
Singapore General Hospital
Singapore, 169608
About this study
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)
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).
Read more
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
- Being tested
- Linvoseltamab, Elotuzumab, Pomalidomide, Dexamethasone
- Keywords
- BCMA X CD3 Bispecific Monoclonal Antibody, CD38 antibody, Proteasome inhibitor, Lenalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinvoseltamabDrug
Also called REGN5458, Lynozyfic™
REGN5458 will be administered by intravenous (IV) infusion
ElotuzumabDrug
Also called Empliciti
Elotuzumab will be administered by IV infusion
PomalidomideDrug
Also called Pomalyst
Pomalidomide capsules will be administered by mouth (PO)
DexamethasoneDrug
Also called Decadron
Dexamethasone tablets/capsules will be administered PO and/or by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Linvoseltamab | Experimental | Randomization 1:1 Receives: Drug: Linvoseltamab |
| Elotuzumab/Pomalidomide/Dexamethasone (EPd) | Active comparator | Randomization 1:1 Receives: Drug: Elotuzumab; Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) response criteria determined by Independent Review Committee (IRC) in CD38 antibody exposed participants
Measured: Up to approximatively 5 years
Secondary outcomes (63)
PFS per IMWG response criteria determined by IRC in all participants
Measured: Up to approximatively 5 years
Objective Response (OR) of Complete Response (CR) or better per IMWG response criteria as determined by IRC in CD38 antibody exposed participants
Measured: Up to approximatively 5 years
OR of CR or better per IMWG response criteria as determined by IRC in all participants
Measured: Up to approximatively 5 years
Overall Survival (OS) in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
OS in all participants
Measured: Up to approximatively 5 years
Incidence of minimal residual disease (MRD) negative status in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
Incidence of MRD negative status in all participants
Measured: Up to approximatively 5 years
Mean change in the worst pain score measured by Brief Pain Inventory-Short Form (BPI-SF) Item 3 in participants previously exposed to CD38 antibodies
The BPI-SF is a validated, self-administered questionnaire designed to measure a participant's perceived level of pain. The BPI-SF Item 3 uses a numeric rating scale to assess pain severity and pain interference in the past 24 hours. The numeric rating scale ranges from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate greater intensity of pain.
Measured: Baseline to week 12
Mean change in the worst pain score measured by BPI-SF Item 3 in all participants
The BPI-SF is a validated, self-administered questionnaire designed to measure a participant's perceived level of pain. The BPI-SF Item 3 uses a numeric rating scale to assess pain severity and pain interference in the past 24 hours. The numeric rating scale ranges from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate greater intensity of pain.
Measured: Baseline to week 12
Incidence of treatment emergent adverse events (TEAEs) in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
Incidence TEAEs in all participants
Measured: Up to approximatively 5 years
Severity of TEAEs in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
Severity of TEAEs in all participants
Measured: Up to approximatively 5 years
Incidence of adverse events of special interest (AESI) in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
Incidence of AESI in all participants
Measured: Up to approximatively 5 years
Severity of AESI in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
Severity AESI in all participants
Measured: Up to approximatively 5 years
Incidence of Serious Adverse Events (SAE) in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
Incidence of SAE in all participants
Measured: Up to approximatively 5 years
Severity of SAE in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
Severity of SAE in all participants
Measured: Up to approximatively 5 years
PFS per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
PFS per IMWG response criteria as determined by the investigator in all participants
Measured: Up to approximatively 5 years
OR of Partial Response (PR) or better per IMWG response criteria as determined by the IRC in CD38 antibody exposed participants
Measured: Up to approximatively 5 years
OR of PR or better per IMWG response criteria as determined by the IRC in all participants
Measured: Up to approximatively 5 years
OR of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by IRC in CD38 antibody exposed participants
Measured: Up to approximatively 5 years
OR of VGPR or better per IMWG response criteria as determined by IRC in all participants
Measured: Up to approximatively 5 years
OR of PR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
OR of PR or better per IMWG response criteria as determined by the investigator in all participants
Measured: Up to approximatively 5 years
OR of VGPR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
OR of VGPR or better per IMWG response criteria as determined by the investigator in all participants
Measured: Up to approximatively 5 years
OR of CR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
OR of CR or better per IMWG response criteria as determined by the investigator in all participants
Measured: Up to approximatively 5 years
Duration of Response (DoR) as per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
DoR as per IMWG response criteria as determined by the investigator in all participants
Measured: Up to approximatively 5 years
DoR as per IMWG response criteria as determined by the IRC in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
DoR as per IMWG response criteria as determined by the IRC in all participants
Measured: Up to approximatively 5 years
Duration of MRD negative status in the bone marrow in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
Duration of MRD negative status in the bone marrow in all participants
Measured: Up to approximatively 5 years
Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the investigator in all participants
Measured: Up to approximatively 5 years
Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the IRC in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the IRC in all participants
Measured: Up to approximatively 5 years
Concentration of linvoseltamab in the serum over time in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
Concentration of linvoseltamab in the serum over time in all participants
Measured: Up to approximatively 5 years
Incidence of antidrug antibodies (ADAs) in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
Incidence of ADAs in all participants
Measured: Up to approximatively 5 years
Titer of ADAs in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
Titer of ADAs in all participants
Measured: Up to approximatively 5 years
Incidence of neutralizing antibodies (Nabs) to linvoseltamab over time in participants previously exposed to CD38 antibodies
Measured: Up to approximatively 5 years
Incidence of Nabs to linvoseltamab over time in all participants
Measured: Up to approximatively 5 years
Proportion of Pain Responders in participants previously exposed to CD38 antibodies
Defined by at least a 2-point reduction from baseline in the BPI-SF Item 3 without an increase in analgesic use using the modified Analgesic Quantification Algorithm (AQA).
Measured: At week 12
Proportion of Pain Responders in all participants
Defined by at least a 2-point reduction from baseline in the BPI-SF Item 3 without an increase in analgesic use using the modified Analgesic Quantification Algorithm (AQA).
Measured: At week 12
Change in patient-reported global health status/quality of life (QoL), per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in participants previously exposed to CD38 antibodies
The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
Measured: Baseline to week 12
Change in patient-reported QoL, per EORTC QLQ-C30 in all participants
The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
Measured: Baseline to week 12
Change in patient reported disease symptoms per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20]) in participants previously exposed to CD38 antibodies
The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems.
Measured: Baseline to week 12
Change in patient reported disease symptoms per EORTC QLQ-MY20 in all participants
The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems.
Measured: Baseline to week 12
Patient-Reported Outcomes in Patient Global Impression of Symptom Severity (PGIS) in participants previously exposed to CD38 antibodies
The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe".
The global anchor, PGIS will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.
Measured: Baseline to week 12
Patient-Reported Outcomes in PGIS in all participants
The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe".
The global anchor, PGIS will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.
Measured: Baseline to week 12
Patient-Reported Outcomes in Patient Global Impression of Change (PGIC) in participants previously exposed to CD38 antibodies
The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change".
The global anchor, PGIC will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.
Measured: Baseline to week 12
Patient-Reported Outcomes in PGIC in all participants
The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change".
The global anchor, PGIC will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.
Measured: Baseline to week 12
Change in patient-reported general health status per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) in participants previously exposed to CD38 antibodies
The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: Baseline to week 12
Change in patient-reported general health status per EQ-5D-5L in all participants
The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start18 Sep 2023
- Primary completion19 Apr 2033 (estimated)
- Study completion19 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Refractory Multiple Myeloma (RRMM)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730036
- Sponsor's protocol ID
- R5458-ONC-2245
- Other IDs
- 2022-501396-62-00
- Acronym
- LINKER-MM3
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2023
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing