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Clinical Trials in Italy / NCT05730036
Recruiting Phase 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

NCT05730036 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2023-09-18
Last updated
2026-03-06

Condition(s) studied

Relapsed Refractory Multiple Myeloma (RRMM)

Investigational drug(s) / intervention(s)

Linvoseltamab →Elotuzumab →Pomalidomide →Dexamethasone →

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: 1. Age 18 years or older (or legal adult age in the country) at the time of the screening visit. 2. 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. 3. 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. 4. Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol 5. Adequate hematologic function and hepatic function within 7 days of randomization, as well as adequate renal and cardiac function and corrected calcium 6. Life expectancy of at least 6 months Key Exclusion Criteria: 1. Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes). 2. Prior treatment with elotuzumab and/or pomalidomide 3. Participants with known MM brain lesions or meningeal involvement 4. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter 5. 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. 6. Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed. 7. 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). 8. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug 9. 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

Primary outcome measure(s)

Trial sites (159)

FacilityCityRegionStatus
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.

More Regeneron Pharmaceuticals trials in Italy

Official registry record

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