Multiple Myeloma Clinical Trial
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
Summary
The 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 the 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 this form), one of these standard treatment options. Half of the participants in this study will get linvoseltamab, and the other half will get EPd. Both linvoseltamab and EPd will be referred to as "study drugs" in this form.
The 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 Criteria
Key Inclusion Criteria:
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
Key Exclusion Criteria:
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.
NOTE: Other protocol defined inclusion/exclusion criteria apply
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There are 66 Locations for this study
Los Angeles California, 90095, United States
Louisville Kentucky, 40207, United States
Stony Brook New York, 11794, United States
Charlotte North Carolina, 28204, United States
Portland Oregon, 97227, United States
Seattle Washington, 98109, United States
Camperdown New South Wales, 2050, Australia
St Leonards New South Wales, 2065, Australia
Herston Queensland, 4029, Australia
South Brisbane Queensland, 4101, Australia
Geelong Victoria, 3220, Australia
Heidelberg Victoria, 3084, Australia
Melbourne Victoria, 3065, Australia
Salvador Bahia, 41253, Brazil
Bento Goncalves Rio Grade Do Sul, 95700, Brazil
Porto Alegre Rio Grande Do Sul, 90110, Brazil
Lages Santa Catarina, 88501, Brazil
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 2, Canada
Villejuif Paris, 94800, France
Lille , 59037, France
Paris , 75015, France
Ramat Gan Hamerkaz, 52656, Israel
Haifa , 31096, Israel
Haifa , 34362, Israel
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Tel Aviv , 64239, Israel
Meldola Forli Cesena, 47014, Italy
Ancona , 60126, Italy
Pavia , 27100, Italy
Ravenna , 48121, Italy
Reggio Emilia , 42123, Italy
Torino , 10126, Italy
Turin , 10060, Italy
Busan , 47392, Korea, Republic of
Busan , 49241, Korea, Republic of
Hwasun , 58128, Korea, Republic of
Incheon , 28265, Korea, Republic of
Jeonju , 54907, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Katowice , 40-51, Poland
Singapore , 16985, Singapore
Gijon Asturias, 33203, Spain
Oviedo Asturias, 33011, Spain
Palma de Mallorca Baleares, 07198, Spain
Badalona Barcelona, 08916, Spain
Palma de Mallorca Islas Baleares, 07120, Spain
Pozuelo Madrid, 28223, Spain
Pamplona Navarra, 31008, Spain
Alicante , 03010, Spain
Barcelona , 08036, Spain
Madrid , 28006, Spain
Madrid , 28027, Spain
Madrid , 28040, Spain
Valencia , 46026, Spain
Zaragoza , 50009, Spain
Kaohsiung , 807, Taiwan
Taoyuan , 333, Taiwan
Sutton Surrey, SM2 5, United Kingdom
London , SE1 9, United Kingdom
London , W12 0, United Kingdom
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