LINKER-MM3 R5458-ONC-2245
An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti- BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients With Relapsed/Refractory Multiple Myeloma (LINKER-MM3)
Trial 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:
1) How long participants benefit from receiving linvoseltamab compared with EPd.
2) How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much.
3) What side effects happen from taking linvoseltamab compared to EPd.
4) How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd.
5) If there is any improvement in pain after treatment with linvoseltamab compared to EPd.
Receptor status / problem studied:
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.
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, hepatic, renal and cardiac function, as well as evidence of adequate bone marrow reserves.
6) Life expectancy of at least 6 months.
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.
6) Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies.
7) Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug.
8) 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.
Trial Title
LINKER-MM3 R5458-ONC-2245
Diagnosis
Multiple myeloma
Type of trial
Pharmaceutical
Type of treatement
Haematology
Phase
III