Linvoseltamab + Tocilizumab for Multiple Myeloma
(POPLIN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether taking tocilizumab (an immunosuppressive drug) before linvoseltamab (a new potential drug) reduces the risk of Cytokine Release Syndrome (CRS), a condition where the immune system overreacts, in people with relapsed or treatment-resistant Multiple Myeloma. The trial targets those who have already tried at least four other treatments. Researchers aim to assess the safety and effectiveness of linvoseltamab after tocilizumab administration and to monitor any side effects or additional treatments required. Participants should have experienced Multiple Myeloma progression despite previous treatments. As a Phase 4 trial, this research seeks to understand how the already FDA-approved treatment benefits more patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for linvoseltamab and tocilizumab?
Research has shown that linvoseltamab is generally safe for treating relapsed or refractory multiple myeloma. Studies have demonstrated a consistent safety record that is usually manageable. For instance, patients experienced fewer infections after six months of treatment. However, serious side effects occurred in 74% of patients, with 7% experiencing fatal reactions, including severe infections like sepsis and chronic kidney disease.
The FDA has already approved linvoseltamab for this condition, indicating that its safety has been reviewed and deemed acceptable for use. This approval offers some reassurance about its overall safety, but participants should remain aware of the possibility of serious side effects. It is crucial to discuss any concerns with a healthcare provider before joining a trial.12345Why are researchers enthusiastic about this study treatment?
Linvoseltamab is unique because it offers a novel approach to treating multiple myeloma by targeting BCMA (B-cell maturation antigen), a protein found on the surface of myeloma cells. Unlike traditional treatments like proteasome inhibitors or immunomodulatory drugs, Linvoseltamab specifically engages the immune system to fight cancer cells more directly. Researchers are excited about this treatment because it could potentially lead to more effective and targeted therapies, providing new hope for patients with multiple myeloma who have limited options.
What evidence suggests that linvoseltamab and tocilizumab could be effective for multiple myeloma?
Studies have shown that linvoseltamab effectively treats relapsed or refractory multiple myeloma, a type of blood cancer. In one study, 71% of patients experienced a response to the treatment. Another study found that patients lived for a median of 31.4 months after starting treatment with linvoseltamab, which is promising for those with advanced stages of the disease. Additionally, linvoseltamab outperformed a similar drug, improving outcomes such as the time patients lived without their cancer worsening. These findings suggest that linvoseltamab can be a strong option for those who have already tried several treatments. Participants in this trial will receive linvoseltamab, and the study will also explore the effects of combining it with tocilizumab.678910
Who Is on the Research Team?
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for adults with multiple myeloma that has come back or not responded after at least four different treatments, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. Participants must be able to care for themselves most of the time.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tocilizumab before the first dose of linvoseltamab to mitigate the risk of Cytokine Release Syndrome (CRS)
Follow-up
Participants are monitored for safety, tolerability, and effectiveness of linvoseltamab, including the occurrence of CRS and infections
What Are the Treatments Tested in This Trial?
Interventions
- Linvoseltamab
- Tocilizumab
Trial Overview
The study tests if giving tocilizumab before linvoseltamab can lower the risk of cytokine release syndrome (CRS) in people with hard-to-treat multiple myeloma. It looks at safety, side effects, and how well this approach works.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School
Citations
Effectiveness of linvoseltamab versus real-world standard ...
The median OS was 27.8 months in the linvoseltamab cohort compared with 10.1 months in the weighted RW SOC cohort, yielding a weighted HR of ...
2.
cancernetwork.com
cancernetwork.com/view/linvoseltamab-may-improve-outcomes-vs-teclistamab-in-r-r-multiple-myelomaLinvoseltamab May Improve Outcomes vs Teclistamab in R ...
Linvoseltamab (Lynozyfic) showed statistically significant improvements in outcomes such as progression-free survival (PFS) and duration of ...
3.
clinical-lymphoma-myeloma-leukemia.com
clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(25)04283-1/fulltextLinvoseltamab in Patients With Relapsed/Refractory ...
Results As of July 23, 2024 (data cutoff), the objective response rate (ORR) was 71% median overall survival was 31.4 months.
Orlowski Calls Linvoseltamab Results “the Best Single- ...
linvoseltamab monotherapy achieves a 79% overall response rate in newly diagnosed MM patients, with 92% achieving MRD negativity.
5.
newsroom.regeneron.com
newsroom.regeneron.com/news-releases/news-release-details/linvoseltamab-combination-carfilzomib-or-bortezomib-showsLinvoseltamab in Combination with Carfilzomib or Bortezomib ...
With a median follow-up of 15 months, efficacy results across all dose levels showed a 90% objective response rate (ORR; 19 of 21 patients), with 76% (16 of 21 ...
Linvoseltamab Yields Favorable Safety Profile and ...
Linvoseltamab-gcpt showed a 100% overall response rate in high-risk smoldering multiple myeloma patients, with significant MRD negativity rates.
Linvoseltamab in Patients With Relapsed/Refractory ...
Linvoseltamab demonstrated a generally manageable and consistent safety profile, with reduced rate of infection after 6 months of treatment. Data Sharing.
Linvoseltamab for Treatment of Relapsed/Refractory ...
Linvoseltamab 200 mg induced deep and durable responses, with a median DOR of 29.4 months, in patients with RRMM with an acceptable safety ...
Linvoseltamab (BCMAxCD3) Initial Pivotal Phase 2 Data ...
Linvoseltamab (BCMAxCD3) Initial Pivotal Phase 2 Data Show Clinically Meaningful Responses in Patients with Heavily Pre-treated Multiple Myeloma.
NCT03761108 | Phase 1/2 Study of Linvoseltamab in Adult ...
The main purpose of this study is to learn about the safety of linvoseltamab the best dose of linvoseltamab to give to patients with multiple myeloma
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