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 (LINKER-MM3)

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Full Title:
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)
Myeloma stage or condition:
Relapsed Refractory Multiple Myeloma (RRMM)
Study phase:
Phase 3
Summary/Purpose:
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 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
Detailed Description:
Not available
Treatments:
Drug : Linvoseltamab

REGN5458 will be administered by intravenous (IV) infusion

Drug : Elotuzumab

Elotuzumab will be administered by IV infusion

Drug : Pomalidomide

Pomalidomide capsules will administered by mouth (PO)

Drug : Dexamethasone

Dexamethasone tablets/capsules will be administered PO and/or by IV infusion

Study Arms:
Experimental : Linvoseltamab
Randomization 1:1
Active Comparator : Elotuzumab/Pomalidomide/Dexamethasone (EPd)
Randomization 1:1
Study Type:
Interventional
Study Design:
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)
Recruitment status:
Recruiting
Eligibility criteria:
/li>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, hepatic, renal and cardiac function, as well as evidence of adequate bone marrow reserves 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. 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. NOTE: Other protocol defined inclusion/exclusion criteria apply
Locations / Centres:

University Health Network (UHN) - Princess Margaret Cancer Centre, Toronto, Ontario – Recruiting

Contacts:
Name: Clinical Trials Administrator
Phone: 844-734-6643
Email: [email protected]
Publications:
???
First posted:
2023-02-15
Actual start date:
September 18, 2023
Last updated:
2024-03-26
Estimated enrollment:
300
Estimated completion date:
2032-12-26
Estimated primary completion date:
2032-12-26
Condition:
Relapsed Refractory Multiple Myeloma (RRMM)
Gender:
All
Ages:
18 Years-N/A
Accepts healthy volunteers:
No
Listed location countries:
Australia
Canada
France
Israel
Italy
Korea, Republic of
Poland
Singapore
Spain
Taiwan
United Kingdom
United States
NCT number:
NCT05730036
Other study ID numbers:
R5458-ONC-2245
Has Data monitoring committee:
Yes
U.S. FDA-regulated product:
Yes
IPD Sharing Statement :
???
Responsible party:
Sponsor
Study sponsor:
lead_sponsor
Regeneron Pharmaceuticals
Industry
Collaborators:
???
Investigators:
Clinical Trial Management Regeneron Pharmaceuticals
Protocol Registration and Results System:
???
Verification date:
2024-02-01