← Back to Search

Monoclonal Antibodies

Phase 1 cohort for Multiple Myeloma (LINKER-MM4 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Key

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

LINKER-MM4 Trial Summary

This trial tests a drug to see if it's safe & effective to treat multiple myeloma & how it moves throughout the body & how the immune system responds.

Who is the study for?

This trial is for adults under 70 with newly diagnosed symptomatic multiple myeloma who haven't had treatment, except possibly short-term steroids or emergency radiation. They should be fit enough for a transplant and have good heart, liver, kidney, and lung function.Check my eligibility

What is being tested?

The study tests Linvoseltamab's safety and optimal dosing in Phase 1. In Phase 2, it evaluates its effectiveness against multiple myeloma. It also examines how the drug moves in the body and its impact on immune response and blood markers like BCMA.See study design

What are the potential side effects?

While specific side effects of Linvoseltamab are not detailed here, similar drugs can cause infusion reactions, fatigue, nausea, bone marrow suppression leading to low blood counts which increases infection risk.

LINKER-MM4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

It seems like there might be a typo or incomplete information. Could you please provide more details or clarify the criterion you'd like to have rewritten in plain language?

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I have been diagnosed with symptomatic multiple myeloma.

LINKER-MM4 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events of special interest (AESIs)

Incidence of dose-limiting toxicities (DLTs)

Incidence of treatment-emergent adverse events (TEAEs)

+5 more

Secondary outcome measures

Cluster of differentiation 34+ (CD34+) stem cell yield

Concentrations of Linvoseltamab in serum

Concentrations of total soluble B-cell maturation antigen (BCMA)

+25 more

LINKER-MM4 Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 2 - transplant ineligible cohortExperimental Treatment1 Intervention

Transplant-ineligible participants, enrolled in dose expansion, will receive selected Linvoseltamab regimen until disease progression as per protocol.

Group II: Phase 2 - transplant eligible cohortExperimental Treatment1 Intervention

Transplant-eligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen for a fixed duration of treatment as per protocol

Group III: Phase 1 cohortExperimental Treatment1 Intervention

Linvoseltamab dose escalation (part A) and dose expansion (part B) for participants with NDMM who are treatment-naïve.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

622 Previous Clinical Trials

380,599 Total Patients Enrolled

9 Trials studying Multiple Myeloma

1,361 Patients Enrolled for Multiple Myeloma

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

263 Previous Clinical Trials

251,282 Total Patients Enrolled

6 Trials studying Multiple Myeloma

1,290 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant count for this clinical examination?

"Affirmative. Clinicaltrials.gov confirms that this experimental medicine, initially posted on December 8th 2023 is accepting applications. 132 individuals are needed for the single-site trial from 1 location."

Answered by AI

Are there any vacancies in this clinical experiment that can be filled by prospective test-subjects?

"As per the information on clinicaltrials.gov, this investigation is presently searching for participants. The trial was initiated on December 8th 2023 and last updated on December 5th 2023."

Answered by AI

What is the goal of this experiment?

"The primary objective of this extended clinical trial, which is to be observed for 5 years, is assessing the portion of patients that achieve minimal residual disease (MRD)-negative status after their first treatment period and transition into a second. Additionally, key secondary endpoints include progression-free survival in both transplant eligible and ineligible individuals, incidence of any adverse reactions caused by the intervention ,and duration of response based on International Myeloma Working Group criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment

2023. "A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05828511.