Linvoseltamab + Carfilzomib for Multiple Myeloma
(LINKER-MM5 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called linvoseltamab, alone or with carfilzomib, for people with multiple myeloma that has progressed after 1-3 previous treatments. The goal is to determine if this combination works better and lasts longer than current standard treatments. Researchers are examining side effects, how the body processes the drug, and potential resistance development. People who have tried lenalidomide and a specific type of drug but still experience worsening multiple myeloma might be suitable for this trial. As a Phase 3 trial, this study is the final step before potential FDA approval, offering participants a chance to contribute to a promising new treatment option.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using linvoseltamab and carfilzomib together is generally safe for treating multiple myeloma. Studies have found that 90% of patients respond well to this treatment, which is very encouraging. The side effects of this combination align with those expected from each drug individually and can usually be managed.
Some patients have experienced infections, but these tend to decrease after six months of treatment. The side effects are typical compared to other similar treatments, suggesting that most patients handle the combination well. Prospective trial participants might find this information helpful in considering the potential risks and benefits.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Linvoseltamab combined with Carfilzomib for multiple myeloma because of its novel approach to treatment. Unlike traditional options like proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies, Linvoseltamab is a bispecific antibody that targets two different proteins, potentially enhancing its effectiveness against myeloma cells. This dual-targeting mechanism could offer a more precise attack on cancer cells, potentially improving patient outcomes and reducing side effects. Additionally, combining Linvoseltamab with Carfilzomib, a well-known proteasome inhibitor, may result in a synergistic effect, further boosting its cancer-fighting capabilities.
What evidence suggests that this trial's treatments could be effective for Multiple Myeloma?
This trial will evaluate the combination of linvoseltamab and carfilzomib for treating multiple myeloma. Studies have shown that this combination effectively treats multiple myeloma that has returned or is unresponsive to other treatments. In earlier research, this combination helped 90% of patients, indicating their cancer responded to the treatment. Specifically, about 76% of patients achieved a complete response, with no signs of cancer detected. The treatment also showed lasting effects, with 87% of patients still benefiting after one year, and 83% not experiencing any cancer progression. These results suggest that the combination of linvoseltamab and carfilzomib could be very promising for patients who have already tried other therapies.12467
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 1 to 3 previous treatments, including lenalidomide and either a proteasome inhibitor or anti-CD38 antibody. People with certain nerve disorders, specific blood cancers, CNS involvement, or prior BCMA T-cell therapy cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive linvoseltamab alone or in combination with carfilzomib, compared to standard treatments for Multiple Myeloma
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Carfilzomib
- Linvoseltamab
Trial Overview
The study compares linvoseltamab alone and linvoseltamab plus carfilzomib against standard treatment combinations (which may include dexamethasone, pomalidomide, daratumumab, bortezomib) in people with relapsed/refractory multiple myeloma. Participants are randomly assigned to different groups.
How Is the Trial Designed?
5
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
Linvoseltamab (LINVO) + carfilzomib (CFZ) in patients (pts) ...
Results: As of Sep 30, 2024, 18 pts were treated at DL1 (n = 12) or DL1b (n = 6). Median duration of follow-up was 16.9 (DL1) and 7.7 months ( ...
2.
onclive.com
onclive.com/view/linvoseltamab-plus-carfilzomib-is-safe-feasible-and-elicits-durable-responses-in-r-r-myelomaLinvoseltamab Plus Carfilzomib Is Safe, Feasible, and ...
Linvoseltamab and carfilzomib combination showed a 90% overall response rate in relapsed/refractory multiple myeloma patients, with notable ...
Effectiveness of linvoseltamab versus real-world standard ...
Treatment patterns and outcomes in triple-class exposed patients with relapsed and refractory multiple myeloma: findings from the Flatiron ...
4.
targetedonc.com
targetedonc.com/view/linvoseltamab-carfilzomib-shows-promising-efficacy-in-heavily-pretreated-rrmmLinvoseltamab/Carfilzomib Shows Promising Efficacy in ...
The one-year duration of response was 87%, and progression-free survival at 1 year reached 83%. “At a medium for about 15 months, the overall ...
Original Study Linvoseltamab in Patients With Relapsed/ ...
Long-term treatment with linvoseltamab 200 mg achieved deep and durable responses in patients with relapsed/refractory multiple myeloma (RRMM). •. Linvoseltamab ...
6.
targetedonc.com
targetedonc.com/view/linvoseltamab-plus-carfilzomib-shows-manageable-safety-in-rrmmLinvoseltamab Plus Carfilzomib Shows Manageable Safety ...
Early results from LINKER-MM2 show that linvoseltamab plus carfilzomib led to a safety profile consistent with the known effects of each agent.
Linvoseltamab in Combination with Carfilzomib or ...
“In clinical trials, treatment with linvoseltamab monotherapy in later-line settings generated impressive response rates, warranting.
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