REGN5458 for Multiple Myeloma

(LINKER-MM1 Trial)

Recruiting at 82 trial locations

Overseen By Clinical Trial Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Regeneron Pharmaceuticals

Must be taking: Proteasome inhibitors, IMiDs, anti-CD38

Disqualifiers: Plasma cell leukemia, Amyloidosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 5 years

387 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to learn about the safety of REGN5458 and to find out what is the best dose of REGN5458 to give to patients with multiple myeloma. An additional purpose is to look for any signs that REGN5458 can treat cancer. The study is looking at several other research questions, including: * Side effects that may be experienced by people receiving REGN5458 * How REGN5458 works in the body * How much REGN5458 is present in the blood * How REGN5458 may work to treat cancer

Do I need to stop my current medications to join the trial?

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.

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

This trial is for adults with Multiple Myeloma who've tried at least three prior treatments, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody but haven't seen improvement. They should be in relatively good health otherwise (ECOG ≤ 1). People can't join if they have certain other blood disorders or brain involvement of myeloma, severe heart issues, previous BCMA-targeted therapy except antibody-drug conjugates, or recent stem cell transplants.

Inclusion Criteria

My myeloma can be measured for treatment response.

I have been diagnosed with active Multiple Myeloma.

I have multiple myeloma and no remaining treatment options that could significantly help me.

Exclusion Criteria

I have had a stem cell transplant from a donor or my own within the last 12 weeks.

My heart's pumping ability is less than 40%.

I have brain lesions or meningeal involvement due to multiple myeloma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Phase 1 involves dose escalation and subcutaneous administration of REGN5458; Phase 2 involves low and high dose IV monotherapy

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Treatment Details

Interventions

• REGN5458

Trial Overview The study tests REGN5458 as a solo treatment to see how safe it is and what dose works best (Phase 1), then checks its effectiveness against Multiple Myeloma that's resisted standard treatments (Phase 2). Researchers will also look into how the body processes the drug and any potential impact on quality of life.

Participant Groups

Group I: Linvoseltamab - Phase 2 - Cohort 3 Experimental Treatment 1 Intervention

Anti-interleukin (IL)-6 receptor (R) prophylactic therapy followed by high dose of IV dose of REGN5458 monotherapy. Note: Cohort 3 is not applicable for US.

Group II: Linvoseltamab - Phase 2 - Cohort 2 Experimental Treatment 1 Intervention

High Dose of REGN5458/linvoseltamab IV monotherapy.

Group III: Linvoseltamab - Phase 2 - Cohort 1 Experimental Treatment 1 Intervention

Low Dose of REGN5458/linvoseltamab IV monotherapy.

Group IV: Linvoseltamab - Phase 1 Experimental Treatment 1 Intervention

Phase 1 has two parts. Part 1, consists of REGN5458/linvoseltamab intravenous (IV) dose escalation and Part 2, consists of subcutaneous (SC) administration. Note: subcutaneous (SC) administration is not applicable for US.

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

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