Last updated 11 days ago
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
380 patients around the world
Available in Spain, Brazil, United States
Regeneron Pharmaceuticals
4Research sites
380Patients around the world
This study is for people with
Multiple myeloma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 protocolAdequate hematologic, hepatic, renal and cardiac function, as well as evidence of adequate bone marrow reservesLife expectancy of at least 6 months
- 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 pomalidomideParticipants with known MM brain lesions or meningeal involvementTreatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorterHistory 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.History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorderAny infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drugUncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in the protocol
Sites
Hospital Sao Rafael
Recruiting
Hospital Tacchini
Recruiting
Hospital Mãe de Deus - Porto Alegre
Recruiting
Unidade de Tratamento Oncológico - ANIMI
Recruiting
StudyLINKER-MM3
SponsorRegeneron Pharmaceuticals
Conditions
Multiple myeloma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05730036
