Linvoseltamab: REGN5458 will be administered by intravenous (IV) infusion
Elotuzumab: Elotuzumab will be administered by IV infusion
Pomalidomide: Pomalidomide capsules will be administered by mouth (PO)
Dexamethasone: Dexamethasone tablets/capsules will be administered PO and/or by IV infusion
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
| Facility | City | Region | Status |
|---|---|---|---|
| University of California Los Angeles (UCLA) | Los Angeles | California | Active Not Recruiting |
| University of Florida Division of Sponsored Programs | Gainesville | Florida | Withdrawn |
| University of Kentucky, Markey Cancer Center Clinical Research Organization | Lexington | Kentucky | Active Not Recruiting |
| Norton Cancer Institute | Louisville | Kentucky | Active Not Recruiting |
| Stony Brook University | Stony Brook | New York | Active Not Recruiting |
| Levine Cancer Center | Charlotte | North Carolina | Active Not Recruiting |
| Duke University Medical Center | Durham | North Carolina | Withdrawn |
| Kaiser Permanente Northwest | Portland | Oregon | Active Not Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Active Not Recruiting |
| University of Washington | Seattle | Washington | Active Not Recruiting |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | Active Not Recruiting |
| Royal North Shore Hospital | St Leonards | New South Wales | Active Not Recruiting |
| Icon Cancer Centre - Wesley | Auchenflower | Queensland | Active Not Recruiting |
| Royal Brisbane and Women's Hospital | Herston | Queensland | Active Not Recruiting |
| Royal Adelaide Hospital | Adelaide | South Australia | Active Not Recruiting |
| Royal Hobart Hospital | Hobart | Tasmania | Active Not Recruiting |
| Launceston General Hospital | Launceston | Tasmania | Active Not Recruiting |
| St Vincent's Hospital | Fitzroy | Victoria | Active Not Recruiting |
| University Hospital Geelong | Geelong | Victoria | Active Not Recruiting |
| Austin Hospital | Heidelberg | Victoria | Active Not Recruiting |
| One Clinical Research at Hollywood Private Hospital | Nedlands | Western Australia | Active Not Recruiting |
| Clinique Universitaire de Mont Godinne | Yvoir | Namur | Completed |
| AZ Delta Algemeen Ziekenhuis Delta | Roeselare | West-Vlaanderen | Active Not Recruiting |
| Ziekenhuis Netwerk Antwerpen Stuivenberg | Antwerp | Belgium | Active Not Recruiting |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | Withdrawn |
| IDOR - Sao Rafael Salvador Bahia | Salvador | Estado de Bahia | Active Not Recruiting |
| Hospital Erasto Gaertner | Curitiba | Paraná | Active Not Recruiting |
| Associacao Dr Bartholomeu Tacchini | Bento Gonçalves | Rio Grande do Sul | Active Not Recruiting |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | Active Not Recruiting |
| Centro Gaucho Integrado | Porto Alegre | Rio Grande do Sul | Active Not Recruiting |
| Animi Unidade de Tratamento Oncologico | Lages | Santa Catarina | Active Not Recruiting |
| Instituto Americas de Ensino e Pesquisa | Rio de Janeiro | Brazil | Active Not Recruiting |
| A Beneficencia Portuguesa de Sao Paulo, Oncology House | São Paulo | Brazil | Active Not Recruiting |
| Instituto DOr de Pesquisa e Ensino | São Paulo | Brazil | Active Not Recruiting |
| AC Camargo Cancer Center | São Paulo | Brazil | Active Not Recruiting |
| Clinica Medica Sao Germano | São Paulo | Brazil | Active Not Recruiting |
| The Ottawa Hospital Cancer Centre | Ottawa | Ontario | Active Not Recruiting |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Active Not Recruiting |
| University Health Network-Princess Margaret Cancer Center | Toronto | Ontario | Active Not Recruiting |
| Hospital Clinico Universidad de Los Andes | Santiago | Las Condes | Active Not Recruiting |
+ 119 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05730036 on ClinicalTrials.gov ↗ ← All trials in Italy