A Study to Compare Linvoseltamab Monotherapy and Linvosel... | NCT07222761

Studies
A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

NCT07222761

Sponsor

Regeneron Pharmaceuticals

Status

Recruiting

Last Update Posted

Jul 1, 2026Actual

Enrollment

915Estimated

Phase

Phase 3

Conditions

Relapsed and/or Refractory Multiple Myeloma (RRMM)

Interventions

Linvoseltamab
Carfilzomib
Daratumumab
Dexamethasone
Pomalidomide
Bortezomib

Countries

United States
Australia
South Korea
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2024-519504-27-00	EU Trial (CTIS) Number

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2026Actual

Primary Completion Date

May 21, 2029Estimated

Completion Date

Aug 23, 2034Estimated

First Submitted Date

Oct 28, 2025

First Submission Date that Met QC Criteria

Oct 28, 2025

First Posted Date

Oct 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2026

Last Update Posted Date

Jul 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is researching a drug called linvoseltamab (also called "study drug") either given alone or in combination with another anti-myeloma drug called carfilzomib, compared to several standard treatments for progressive Multiple Myeloma (MM) after at least 1 but no more than 3 prior therapies.

The aim of this study is to see if the safety and efficacy of linvoseltamab alone or in combination with carfilzomib can deliver better outcomes (deeper and longer responses that help extend life) than standard treatment options.

The study is looking at several other research questions, including:

What side effects may happen from taking the study drug
How much study drug is in the blood at different times
Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

915Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Part 1: Arm A	Experimental	Drug: Linvoseltamab
Part 1: Arm B	Experimental	Drug: Linvoseltamab Drug: Carfilzomib
Part 2: Arm A	Experimental	Drug: Linvoseltamab
Part 2: Arm B	Experimental	Drug: Linvoseltamab Drug: Carfilzomib
Part 2: Arm C	Experimental	Drug: Carfilzomib Drug: Daratumumab Drug: Dexamethasone Drug: Pomalidomide Drug: Bortezomib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Linvoseltamab	Drug	Administered per the protocol	Part 1: Arm A Part 1: Arm B Part 2: Arm A Part 2: Arm B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of Treatment Emergent Adverse Events (TEAEs)	Part 1	Up to 5 years
Severity of TEAEs	Part 1	Up to 5 years
Occurrence of Adverse Events of Special Interest (AESI)	Part 1	Up to 5 years
Severity of AESIs	Part 1	Up to 5 years
Occurrence of Serious Adverse Events (SAEs)	Part 1	Up to 5 years
Severity of SAEs	Part 1	Up to 5 years
Minimal Residual Disease (MRD)-negative Complete Response (CR)	Part 2	At 12 months
Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC	Part 2	Up to 5 years

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of grade ≥2 Cytokine Release Syndrome (CRS)	Part 1	Up to 28 days
Timing of grade ≥2 CRS	Part 1	Up to 28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Participant with RRMM who received at least 1 but not more than 3 prior lines of therapy, which must have included treatment with lenalidomide and either a Protease Inhibitor (PI) or anti-CD38 monoclonal antibody
Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy

Key Exclusion Criteria:

Prior treatment with a T cell-based immunotherapy targeting BCMA, including BCMA-directed bispecific antibodies, Bispecific T-cell Engagers (BiTEs), and Chimeric Antigen Receptor (CAR) T cells. Antibody-drug conjugates targeting BCMA (eg, belantamab mafodotin) are not excluded
Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement
History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder

NOTE: Other protocol defined inclusion/exclusion criteria apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Trials Administrator	Contact	844-734-6643		clinicaltrials@regeneron.com

Overall Officials

Name	Affiliation	Role
Clinical Trial Management	Regeneron Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory Winship Cancer Institute	Recruiting	Atlanta	Georgia	30322	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

When Regeneron has:

received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
the legal authority to share the data, and
ensured the ability to protect participant privacy

Access Criteria

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

URL

https://vivli.org/

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
D001897	Boronic Acids
D000148	Acids, Noncarboxylic
D000143	Acids
D007287	Inorganic Chemicals
D001896	Boron Compounds
D009930	Organic Chemicals
D011719	Pyrazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Term
C524865	carfilzomib
C556306	daratumumab
D003907	Dexamethasone
C467566	pomalidomide
D000069286	Bortezomib