915 Participants NeededMy employer runs this trial

Linvoseltamab + Carfilzomib for Multiple Myeloma

(LINKER-MM5 Trial)

Recruiting at 23 trial locations
CT
Overseen ByClinical Trials Administrator
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Regeneron Pharmaceuticals
Must be taking: Lenalidomide, Protease Inhibitor
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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?

CT

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

I am able to care for myself and do light activities.
I have relapsed or refractory multiple myeloma and had 1-3 prior treatments, including lenalidomide and a PI or anti-CD38 antibody.
My disease has gotten worse during or after my last treatment.

Exclusion Criteria

I have a history of a brain or nerve disease like PML or a movement disorder.
I have been diagnosed with plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome.
My myeloma has spread to my brain or spinal cord.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive linvoseltamab alone or in combination with carfilzomib, compared to standard treatments for Multiple Myeloma

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

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

Group I: Part 2: Arm CExperimental Treatment5 Interventions
Group II: Part 2: Arm BExperimental Treatment2 Interventions
Group III: Part 2: Arm AExperimental Treatment1 Intervention
Group IV: Part 1: Arm BExperimental Treatment2 Interventions
Group V: Part 1: Arm AExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

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 ( ...

Linvoseltamab 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 ...

Linvoseltamab/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 ...

Linvoseltamab 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.