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Monoclonal Antibodies

Linvoseltamab Combo for Multiple Myeloma

Phase 1

Recruiting

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

For Cohort 6: Prior treatment with isatuximab is allowed if previously tolerated. Additionally, participants must undergo at least a 3-month washout following prior anti-CD38 antibody therapy before enrollment

Adequate creatinine clearance, hematologic function and hepatic function, as defined in protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is researching an experimental drug for multiple myeloma in combination with other cancer treatments to determine safety and effectiveness.

Who is the study for?

Adults with multiple myeloma resistant to standard treatments can join this trial. They must have tried at least three therapies, or two if they've had specific drugs. Good kidney, blood, and liver function are needed, along with a life expectancy of over six months. Certain prior treatments require a waiting period before joining.Check my eligibility

What is being tested?

The trial tests linvoseltamab combined with other cancer drugs in patients whose multiple myeloma has returned after treatment. It aims to find the safe dose for combinations and see how well they work together against the cancer.See study design

What are the potential side effects?

Potential side effects include reactions related to the immune system attacking normal cells, infusion-related reactions from drug administration, fatigue, digestive issues like nausea or diarrhea, blood disorders such as anemia or clotting problems, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I have had isatuximab before and tolerated it well. It's been 3 months since my last anti-CD38 therapy.

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My kidney, blood, and liver functions meet the study's requirements.

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I have taken pomalidomide before, tolerated it well, and it's been 6 months since my last dose.

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I am fully active and can carry on all pre-disease activities without restriction.

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 laboratory abnormalities

Incidence of pre-defined safety criteria or dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period

+5 more

Secondary outcome measures

Concentrations of total linvoseltamab in serum over time

Duration of response (DOR) by IMWG criteria

Incidence over time of anti-drug antibodies (ADAs) to linvoseltamab

+4 more

Trial Design

9Treatment groups

Experimental Treatment

Group I: Cohort 9: Linvoseltamab + NirogacestatExperimental Treatment1 Intervention

Linvoseltamab + Nirogacestat

Group II: Cohort 8: Linvoseltamab + CemiplimabExperimental Treatment2 Interventions

Linvoseltamab + Cemiplimab

Group III: Cohort 7: Linvoseltamab + FianlimabExperimental Treatment2 Interventions

Linvoseltamab + Fianlimab

Group IV: Cohort 6: Linvoseltamab + IsatuximabExperimental Treatment2 Interventions

Linvoseltamab + Isatuximab

Group V: Cohort 5: Linvoseltamab + PomalidomideExperimental Treatment2 Interventions

Linvoseltamab + Pomalidomide

Group VI: Cohort 4: Linvoseltamab + BortezomibExperimental Treatment2 Interventions

Linvoseltamab + Bortezomib

Group VII: Cohort 3: Linvoseltamab + LenalidomideExperimental Treatment2 Interventions

Linvoseltamab + Lenalidomide

Group VIII: Cohort 2: Linvolseltamab + CarfilzomibExperimental Treatment2 Interventions

Linvoseltamab + Carfilzomib

Group IX: Cohort 1: Linvoseltamab + DaratumumabExperimental Treatment2 Interventions

Linvoseltamab + Daratumumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daratumumab

2014

Completed Phase 3

~1990

Carfilzomib

2017

Completed Phase 3

~1440

Lenalidomide

2005

Completed Phase 3

~1480

Bortezomib

2005

Completed Phase 2

~1090

Pomalidomide

2011

Completed Phase 2

~1020

Isatuximab

2016

Completed Phase 3

~370

Cemiplimab

2015

Completed Phase 3

~1340

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

622 Previous Clinical Trials

380,414 Total Patients Enrolled

9 Trials studying Multiple Myeloma

1,176 Patients Enrolled for Multiple Myeloma

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

263 Previous Clinical Trials

251,097 Total Patients Enrolled

6 Trials studying Multiple Myeloma

1,105 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 enrolment capacity for this research endeavor?

"To ensure the success of this trial, a total of 317 qualified patients are required to take part. These individuals can be found at Chu De Lille in Lille, Cantabria and CHU de Montpellier in Montpellier, Navarre."

Answered by AI

What potential risks could be associated with Cohort 1: Linvoseltamab + Daratumumab?

"Due to the preliminary nature of this Phase 1 study, there is limited evidence surrounding both safety and efficacy. For these reasons, Cohort 1: Linvoseltamab + Daratumumab was given a score of 1."

Answered by AI

In what geographic areas is this investigation being conducted?

"The current medical study is enrolling patients from 17 locations, with the most prominent ones situated in Lille, Montpellier and Paris. To minimize commute time for participants selecting a clinic nearby would be wise."

Answered by AI

What medical conditions can typically be remedied with the combination of Linvoseltamab and Daratumumab?

"For treating at least two prior systemic chemotherapy regimens, inflammatory breast cancer (ibc), and amyloidosis, Cohort 1: Linvoseltamab + Daratumumab provides a viable solution."

Answered by AI

Are there any other research investigations that have explored the effectiveness of combining Linvoseltamab and Daratumumab?

"Linvoseltamab + Daratumumab was first assessed in 2004 by Eastern Connecticut Hematology and Oncology Associates. Currently, there are 911 completed trials relating to this drug combination along with 407 that remain active - many of which have begun at Lille, Cantabria."

Answered by AI

Is it possible to enroll in this experiment at the present time?

"According to the information published on clinicaltrials.gov, this experiment is currently recruiting patients. This trial was first made available for participation on August 17th 2022 and has seen its most recent amendment occur on September 4th 2023."

Answered by AI

What ambitions does this trial seek to fulfil?

"This clinical trial, to be conducted over the course of 28 days, seeks to evaluate the Incidence of treatment-emergent adverse events (TEAEs). Additionally, it aims to measure Duration of response (DOR), Progression-free survival (PFS) and Rate of minimal residual disease (MRD) negative status by International Myeloma Working Group criteria in both dose finding portion and dose expansion portion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

2022. "A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05137054.

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