NCT05730036RecruitingPhase 3
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
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)
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 410 (estimated)
- First submitted
- 6 Feb 2023
- Start date
- 18 Sept 2023
- Primary completion date
- 19 Apr 2033
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Multiple myeloma
- NCT number
- NCT05730036
- EU CT number
- 2022-501396-62-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 410
- From 18 Sept 2023 to the primary completion date, 19 Apr 2033
- 150 sites in 18 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with elotuzumab and/or pomalidomide
- 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.
- Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug
Other illness
- Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- 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).
Lab values
- 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
Other
- Participants with known MM brain lesions or meningeal involvement
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (150)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Active, not recruiting |
| ICON Cancer Centre Wesley Coordinator of this site? Confirm its status | Auchenflower | Australia | Active, not recruiting |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Active, not recruiting |
| St. Vincent's Hospital Coordinator of this site? Confirm its status | Fitzroy | Australia | Active, not recruiting |
| University Hospital Geelong Coordinator of this site? Confirm its status | Geelong | Australia | Active, not recruiting |
| Austin Hospital Coordinator of this site? Confirm its status | Heidelberg | Australia | Active, not recruiting |
| Royal Brisbane and Women's Hospital Coordinator of this site? Confirm its status | Herston | Australia | Active, not recruiting |
| Royal Hobart Hospital Coordinator of this site? Confirm its status | Hobart | Australia | Active, not recruiting |
| Launceston General Hospital Coordinator of this site? Confirm its status | Launceston | Australia | Active, not recruiting |
| One Clinical Research at Hollywood Private Hospital Coordinator of this site? Confirm its status | Nedlands | Australia | Active, not recruiting |
| Royal North Shore Hospital Coordinator of this site? Confirm its status | St Leonards | Australia | Active, not recruiting |
| Ziekenhuis Aan De Stroom Coordinator of this site? Confirm its status | Antwerp | Belgium | Active, not recruiting |
| AZ Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Active, not recruiting |
| Associacao Dr. Bartholomeu Tacchini Coordinator of this site? Confirm its status | Bento Gonçalves | Brazil | Active, not recruiting |
| Hospital Erasto Gaertner Coordinator of this site? Confirm its status | Curitiba | Brazil | Active, not recruiting |
| ANIMI - Unidade de Tratamento Oncológico Coordinator of this site? Confirm its status | Lages | Brazil | Active, not recruiting |
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Active, not recruiting |
| Centro Gaucho Integrado Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Active, not recruiting |
| Instituto Americas de Ensino e Pesquisa Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Active, not recruiting |
| IDOR - Sao Rafael Salvador Bahia Coordinator of this site? Confirm its status | Salvador | Brazil | Active, not recruiting |
| Instituto Dor de Pesquisa E Ensino Coordinator of this site? Confirm its status | São Paulo | Brazil | Active, not recruiting |
| A Beneficencia Portuguesa de Sao Paulo, Oncology House Coordinator of this site? Confirm its status | São Paulo | Brazil | Active, not recruiting |
| AC Camargo Cancer Center Coordinator of this site? Confirm its status | São Paulo | Brazil | Active, not recruiting |
| Clinica Medica Sao Germano Coordinator of this site? Confirm its status | São Paulo | Brazil | Active, not recruiting |
| The Ottawa Hospital Cancer Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Active, not recruiting |
| University Health Network - Princess Margaret Cancer Center Coordinator of this site? Confirm its status | Toronto | Canada | Active, not recruiting |
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Active, not recruiting |
| Hospital Clinico Universidad de Los Andes Coordinator of this site? Confirm its status | Santiago | Chile | Active, not recruiting |
| Clinica Alemana de Santiago Coordinator of this site? Confirm its status | Santiago | Chile | Active, not recruiting |
| Fundacion Arturo Lopez Perez Coordinator of this site? Confirm its status | Santiago | Chile | Active, not recruiting |
| Clínica UC San Carlos de Apoquindo Coordinator of this site? Confirm its status | Santiago | Chile | Active, not recruiting |
| Centro Oncologia de Precision Universidad Mayor Coordinator of this site? Confirm its status | Santiago | Chile | Active, not recruiting |
| Centro de Investigaciones Clinicas Vina Del Mar Coordinator of this site? Confirm its status | Viña del Mar | Chile | Active, not recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| University Medical Centre Schleswig-Holstein Coordinator of this site? Confirm its status | Lübeck | Germany | Active, not recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Active, not recruiting |
| Hospital General Universitario de Alicante Coordinator of this site? Confirm its status | Alicante | Spain | Active, not recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario de Cabueñes Coordinator of this site? Confirm its status | Gijón | Spain | Active, not recruiting |
| Institut Català d'Oncologia Coordinator of this site? Confirm its status | Girona | Spain | Active, not recruiting |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Active, not recruiting |
| Catalan Institute of Oncology Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| University Clinic of Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Active, not recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Active, not recruiting |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Active, not recruiting |
| Son Llatzer Hospital Coordinator of this site? Confirm its status | Palma De Mallorca | Spain | Active, not recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| University Clinic of Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Active, not recruiting |
| Hospital Universitario Virgen De Valme Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Universitari Mutua Terrassa Coordinator of this site? Confirm its status | Terrassa | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital Universitario Araba Coordinator of this site? Confirm its status | Vitoria | Spain | Active, not recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Active, not recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
| Queen Elizabeth Hospital Birmingham Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Active, not recruiting |
| Addenbrooke's Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Active, not recruiting |
| Western General Hospital Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Active, not recruiting |
| Hammersmith Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Active, not recruiting |
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Active, not recruiting |
| Royal Marsden Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Active, not recruiting |
| Guy's & St Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Active, not recruiting |
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Withdrawn |
| Lady Davis Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Active, not recruiting |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Active, not recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Active, not recruiting |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Active, not recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Active, not recruiting |
| The Tel Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Active, not recruiting |
| Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria Coordinator of this site? Confirm its status | Alexandria | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Active, not recruiting |
| Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Coordinator of this site? Confirm its status | Candiolo | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Active, not recruiting |
| IRCCS Azienda Ospedaliera Metropolitana Coordinator of this site? Confirm its status | Genoa | Italy | Active, not recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Active, not recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Active, not recruiting |
| Azienda Unità Sanitaria Locale della Romagna Coordinator of this site? Confirm its status | Ravenna | Italy | Active, not recruiting |
| Azienda USL IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Active, not recruiting |
| Casa Sollievo della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Active, not recruiting |
| Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi Coordinator of this site? Confirm its status | Varese | Italy | Active, not recruiting |
| Chiba Cancer Center Coordinator of this site? Confirm its status | Chiba | Japan | Recruiting |
| Fukushima Medical University Coordinator of this site? Confirm its status | Fukushima | Japan | Recruiting |
| Saitama Medical University Hospital Coordinator of this site? Confirm its status | Iruma-gun | Japan | Recruiting |
| Kameda General Hospital Coordinator of this site? Confirm its status | Kamogawa | Japan | Recruiting |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Recruiting |
| National Hospital Organization Okayama Medical Center Coordinator of this site? Confirm its status | Kita-ku | Japan | Recruiting |
| Yamanashi Prefectural Central Hospital Coordinator of this site? Confirm its status | Kofu | Japan | Recruiting |
| National Hospital Organization Kumamoto Medical Center Coordinator of this site? Confirm its status | Kumamoto | Japan | Recruiting |
| Kurume University Hospital Coordinator of this site? Confirm its status | Kurume | Japan | Recruiting |
| Gunma University Hospital Coordinator of this site? Confirm its status | Maebashi | Japan | Recruiting |
| Aichi Medial University Hospital Coordinator of this site? Confirm its status | Nagakute | Japan | Recruiting |
| Ogaki Municipal Hospital Coordinator of this site? Confirm its status | Ōgaki | Japan | Recruiting |
| Sapporo Hokuyu Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| National Hospital Organization Sendai Medical Center Coordinator of this site? Confirm its status | Sendai | Japan | Recruiting |
| NHO Shibukawa Medical Center Coordinator of this site? Confirm its status | Shibukawa | Japan | Recruiting |
| Japanese Red Cross Medical Center Coordinator of this site? Confirm its status | Shibuya-ku | Japan | Recruiting |
| Iwate Medical University Hospital Coordinator of this site? Confirm its status | Shiwa-gun | Japan | Recruiting |
| Osaka University Hospital Coordinator of this site? Confirm its status | Suita-shi | Japan | Recruiting |
| Tokushima Prefectural Central Hospital Coordinator of this site? Confirm its status | Tokushima | Japan | Recruiting |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Active, not recruiting |
| Inje University Busan Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Active, not recruiting |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Active, not recruiting |
| Gachon University Gil Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Active, not recruiting |
| jeonbuk National University Hospital Coordinator of this site? Confirm its status | Jeonju | South Korea | Active, not recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Active, not recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Active, not recruiting |
| Seoul St. Marys Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Active, not recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Active, not recruiting |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Active, not recruiting |
| Albert Schweitzer Ziekenhuis Coordinator of this site? Confirm its status | Dordrecht | Netherlands | Active, not recruiting |
| Stichting Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Active, not recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Pratia Onkologia Katowice Coordinator of this site? Confirm its status | Katowice | Poland | Active, not recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Singapore General Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Active, not recruiting |
| National University Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Active, not recruiting |
| Changhua Christian Hospital Coordinator of this site? Confirm its status | Changhua | Taiwan | Active, not recruiting |
| Hualien Tzu Chi Hospital Coordinator of this site? Confirm its status | Hualien City | Taiwan | Active, not recruiting |
| Kaohsiung Medical University Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Active, not recruiting |
| Kaohsiung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Active, not recruiting |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Withdrawn |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Active, not recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Active, not recruiting |
| Tri-Service General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Active, not recruiting |
| Wanfang Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Active, not recruiting |
| Chang Gung Memorial Hospital, Linkou Branch Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Active, not recruiting |
| Levine Cancer Center Coordinator of this site? Confirm its status | Charlotte | United States | Active, not recruiting |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Withdrawn |
| University of Florida Division of Sponsored Programs Coordinator of this site? Confirm its status | Gainesville | United States | Withdrawn |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Active, not recruiting |
| University of Kentucky, Markey Cancer Center Clinical Research Organization Coordinator of this site? Confirm its status | Lexington | United States | Active, not recruiting |
| University of California Los Angeles (UCLA). Coordinator of this site? Confirm its status | Los Angeles | United States | Active, not recruiting |
| Norton Cancer Institute Coordinator of this site? Confirm its status | Louisville | United States | Active, not recruiting |
| Kaiser Permanente Northwest Coordinator of this site? Confirm its status | Portland | United States | Active, not recruiting |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Active, not recruiting |
| Stony Brook University Coordinator of this site? Confirm its status | Stony Brook | United States | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.