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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
Must not have
Live or attenuated vaccination within 28 days prior to first study drug regimen administration with a vector that has replicative potential
For Cohort 3: Known malabsorption syndrome or pre-existing gastrointestinal (GI) conditions that may impair absorption of lenalidomide (eg, gastric bypass, lap band, or other gastric procedures that would alter absorption); delivery of lenalidomide via nasogastric tube or gastrostomy tube is not allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not received a live vaccine within the last 28 days.
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I do not have conditions that affect how my body absorbs medication.
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I have been diagnosed with a specific blood or bone marrow condition.
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I haven't taken any myeloma treatment within the last 21 days or 5 half-lives, whichever is shorter.
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My heart's pumping ability is below 40%.
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I have brain lesions or meningeal involvement due to multiple myeloma.
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I have not had a brain disorder or seizure in the last year.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~2000
Carfilzomib
2017
Completed Phase 3
~1430
Lenalidomide
2005
Completed Phase 3
~2240
Bortezomib
2005
Completed Phase 3
~1410
Pomalidomide
2011
Completed Phase 2
~1020
Isatuximab
2016
Completed Phase 3
~370
Cemiplimab
2015
Completed Phase 3
~1470

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
665 Previous Clinical Trials
385,424 Total Patients Enrolled
10 Trials studying Multiple Myeloma
1,362 Patients Enrolled for Multiple Myeloma
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
283 Previous Clinical Trials
254,765 Total Patients Enrolled
7 Trials studying Multiple Myeloma
1,291 Patients Enrolled for Multiple Myeloma
~161 spots leftby Mar 2027
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