Last updated 33 hours 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 protocol
Adequate hematologic, hepatic, renal and cardiac function, as well as evidence of adequate bone marrow reserves
Life 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 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.
History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder
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

Sites

Hospital Sao Rafael
Recruiting
Av. São Rafael, 2152 - São Marcos, Salvador - BA, 41253-190
Hospital Tacchini
Recruiting
R. Dr. José Mário Mônaco, 358 - Centro, Bento Gonçalves - RS, 95700-000, Brazil
Hospital Mãe de Deus - Porto Alegre
Recruiting
R. José de Alencar, 286 - Menino Deus, Porto Alegre - RS, 90880-481, Brazil
Unidade de Tratamento Oncológico - ANIMI
Recruiting
R. Mal. Deodoro, 678 - Centro, Lages - SC, 88501-001
LinkedinInstagramFacebook
Terms and ConditionsPrivacy Policy