A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) (LINKER-MM8)

February 19, 2026 updated by: Regeneron Pharmaceuticals

A Phase 2/3, Open-Label, Randomized Study of Linvoseltamab, Bortezomib and Lenalidomide (Linvo-VR) With and Without Autologous Stem Cell Transplantation (ASCT) Vs Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) in Transplant-Eligible Participants With Newly Diagnosed Multiple Myeloma

This study is focused on participants with Newly Diagnosed Multiple Myeloma (NDMM) who are eligible for high dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT).

This study is evaluating a drug called linvoseltamab in combination with standard therapies for multiple myeloma called bortezomib (V) and lenalidomide (R). This combination is abbreviated as Linvo-VR.

The aim of this study is to compare how well Linvo-VR, with and without ASCT, treats myeloma to how well the current standard of care regimen for NDMM treats myeloma. That current standard of care regimen includes the drugs daratumumab (D), bortezomib (V), lenalidomide (R), and dexamethasone (d). This combination is referred to as DVRd. The study is also evaluating if Linvo-VR treats myeloma well enough that ASCT is no longer needed with the first myeloma treatments.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1570

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Participants must have a histologically or cytologically confirmed diagnosis of multiple myeloma, which requires the presence of clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma, and at least one other criteria as defined by the SLiM (>=60%, Light chains I/U >10, Magnetic resonance imaging >1 focal lesion) CRAB (Calcium elevation, Renal insufficiency, Anemia, Bone disease) criteria
  2. Participants must have measurable disease, as defined in the protocol
  3. Participants must be considered eligible for high-dose chemotherapy (melphalan) and ASCT per local standard guidelines
  4. Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  5. Must be willing to defer ASCT

Key Exclusion Criteria:

  1. Any prior therapy for Monoclonal Gammopathy of Undetermined Significance (MGUS), Monoclonal Gammopathy of Renal Significance (MGRS), Smoldering Multiple Myeloma (SMM), or MM, with the exception of those defined in the protocol
  2. Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM (or another plasma cell disorder), or those whose AEs due to agents administered earlier (such as radiation and/or corticosteroids) have not recovered to a severity of grade 0 or grade 1
  3. Participants with non-secretory MM, diagnosis of plasma cell leukemia (>20% circulating plasma cells), symptomatic amyloidosis (including myeloma associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes).
  4. Participants who have known Central Nervous System (CNS) or meningeal involvement with MM or known or suspected Progressive Multifocal Leukoencephalopathy (PML), a history of a neurocognitive condition or CNS movement disorder, OR a history of seizure, Transient Ischemic Attack (TIA), or stroke within 12 months prior to study randomization
  5. Another malignancy besides MM that is progressive or has required treatment in the 3 years preceding randomization with the exceptions defined in the protocol

NOTE: Other protocol defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Linvo-VR with ASCT
Drug: Lenalidomide
Administered per the protocol
Other Names:
  • Revlimid®
Drug: Linvoseltamab
Administered per the protocol
Other Names:
  • REGN5458
  • Lynozyfic™
Drug: Bortezomib
Administered per the protocol
Other Names:
  • Velcade®
Experimental: Linvo-VR without ASCT
Drug: Lenalidomide
Administered per the protocol
Other Names:
  • Revlimid®
Drug: Linvoseltamab
Administered per the protocol
Other Names:
  • REGN5458
  • Lynozyfic™
Drug: Bortezomib
Administered per the protocol
Other Names:
  • Velcade®
Active Comparator: DVRd with ASCT
Drug: Daratumumab
Administered per the protocol
Other Names:
  • Darzalex®
  • Darzalex Faspro®,
Drug: Lenalidomide
Administered per the protocol
Other Names:
  • Revlimid®
Drug: Dexamethasone
Administered per the protocol
Other Names:
  • Decadron®
  • Dexahexal®,
Drug: Bortezomib
Administered per the protocol
Other Names:
  • Velcade®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to day 112
Phase 2
Up to day 112
Severity of TEAEs
Time Frame: Up to day 112
Phase 2
Up to day 112
Achievement of Complete Response or better (≥CR) per International Myeloma Working Group (IMWG) criteria
Time Frame: Up to day 112
Phase 2
Up to day 112
Minimal Residual Disease (MRD) negative CR at 10^-5 per IMWG criteria
Time Frame: Up to 12 months
Phase 3
Up to 12 months
Progression Free Survival (PFS) per IMWG
Time Frame: Up to 5 years
Phase 3
Up to 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to 5 years
Up to 5 years
Time to Very Good Partial Response or better (≥VGPR) per IMWG criteria
Time Frame: Up to 5 years
Up to 5 years
Time to ≥CR per IMWG criteria
Time Frame: Up to 5 years
Up to 5 years
Occurrence of TEAEs
Time Frame: Up to 3.5 years
Phase 2
Up to 3.5 years
Severity of TEAEs
Time Frame: Up to 3.5 years
Phase 2
Up to 3.5 years
Occurrence of Serious Adverse Events (SAEs)
Time Frame: Up to 3.5 years
Phase 2
Up to 3.5 years
Severity of SAEs
Time Frame: Up to 3.5 years
Phase 2
Up to 3.5 years
Occurrence of Cytokine Release Syndrome (CRS)
Time Frame: Up to day 30
Phase 2
Up to day 30
Severity of CRS
Time Frame: Up to day 30
Phase 2
Up to day 30
Occurrence of Cell-Associated Neurotoxicity Syndrome (ICANS)
Time Frame: Up to day 30
Phase 2
Up to day 30
Severity of ICANS
Time Frame: Up to day 30
Phase 2
Up to day 30
Achievement of objective response [Partial Response or better (≥PR)] per IMWG criteria
Time Frame: Up to 5 years
Up to 5 years
Time to ≥PR per IMWG criteria
Time Frame: Up to 5 years
Up to 5 years
Achievement of MRD negative (at 10^-5 sensitivity) CR per IMWG criteria
Time Frame: Up to 5 years
Up to 5 years
Duration Of Response (DOR) of ≥PR per IMWG criteria
Time Frame: Up to 5 years
Up to 5 years
Duration of ≥VGPR per IMWG criteria
Time Frame: Up to 5 years
Up to 5 years
Duration of ≥CR per IMWG criteria
Time Frame: Up to 5 years
Up to 5 years
PFS per IMWG criteria
Time Frame: Up to 5 years
Up to 5 years
Second PFS (PFS2) per IMWG criteria
Time Frame: Up to 5 years
Up to 5 years
Concentrations of total linvoseltamab in serum
Time Frame: Up to 5 years
Up to 5 years
Occurrence of TEAEs
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Severity of TEAEs
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Occurrence of SAEs
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Severity of SAEs
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Occurrence of second primary malignancies
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Change from baseline in Global Health Status (GHS) per European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30)
Time Frame: Up to 5 years

Phase 3 The EORTC QLQ-C30 is a 30-item validated questionnaire developed to measure patient-reported Quality of Life (QoL).

For GHS, scores range from 1 = "very poor" to 5 = "excellent" with higher scores indicating better functioning and positive changes from baseline indicate improvement.
Up to 5 years
Change from baseline in physical functioning per EORTC QLQ-C30
Time Frame: Up to 5 years

Phase 3 The EORTC QLQ-C30 is a validated 30-item questionnaire designed to measure patient-reported quality of life.

Physical functioning is scored from 1 'very poor' to 5 'excellent,' with higher scores indicating better functioning; positive changes from baseline indicate improvement.
Up to 5 years
Change from baseline in role functioning per EORTC QLQ-C30
Time Frame: Up to 5 years

Phase 3 The EORTC QLQ-C30 is a validated 30-item questionnaire designed to measure patient-reported quality of life.

Role functioning is scored from 1 'very poor' to 5 'excellent,' with higher scores indicating better functioning; positive changes from baseline indicate improvement.
Up to 5 years
Change from baseline in pain per EORTC QLQ-C30
Time Frame: Up to 5 years

Phase 3 The EORTC QLQ-C30 is a validated 30-item questionnaire designed to measure patient-reported quality of life.

Pain is scored from 1 = "not at all" to 9 = "very much". Higher scores indicate higher symptom burden.
Up to 5 years
Change from baseline in fatigue per EORTC QLQ-C30
Time Frame: Up to 5 years

Phase 3 The EORTC QLQ-C30 is a validated 30-item questionnaire designed to measure patient-reported quality of life.

Fatigue is scored from1 = "not at all" to 9 = "very much". Higher scores indicate higher symptom burden.
Up to 5 years
Change from baseline in disease symptoms per EORTC QLQ- Multiple Myeloma Module 20 (MY20)
Time Frame: Up to 5 years

Phase 3 The EORTC QLQ-MY20 is a self-administered instrument to assess QoL in persons with MM.

This 20-item questionnaire includes 6 items for disease symptoms. A high score for a symptom scale/item represents a high level of symptomatic problem.
Up to 5 years
Change from baseline in treatment side effects per EORTC QLQ-MY20
Time Frame: Up to 5 years

Phase 3 The EORTC QLQ-MY20 is a self-administered instrument to assess QoL in persons with MM.

This 20-item questionnaire includes 10 items for treatment side effects. A high score for a symptom scale/item represents a high level of symptomatic problem.
Up to 5 years
Change from baseline in body image per EORTC QLQ-MY20
Time Frame: Up to 5 years

Phase 3 The EORTC QLQ-MY20 is a self-administered instrument to assess QoL in persons with MM.

This 20-item questionnaire includes 1 item for treatment body image. A high score for a symptom scale/item represents a high level of symptomatic problem.
Up to 5 years
Change from baseline in future perspective per EORTC QLQ-MY20
Time Frame: Up to 5 years

Phase 3 The EORTC QLQ-MY20 is a self-administered instrument to assess QoL in persons with MM.

This 20-item questionnaire includes 3 items for treatment future perspective. A high score for a symptom scale/item represents a high level of symptomatic problem.
Up to 5 years
Change from baseline in EuroQoL-5 Dimensions 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)
Time Frame: Up to 5 years
Phase 3 The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: "no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems". The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labeled "Best imaginable health state" and "Worst imaginable health state".
Up to 5 years
Time to definitive deterioration in GHS per EORTC QLQ-C30
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to definitive deterioration in physical functioning per EORTC QLQ-C30
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to definitive deterioration in role functioning per EORTC QLQ-C30
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to definitive deterioration in pain per EORTC QLQ-C30
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to definitive deterioration in fatigue per EORTC QLQ-C30
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to definitive deterioration in disease symptoms per EORTC QLQ-MY20
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to definitive deterioration in treatment side effects per EORTC QLQ-MY20
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to definitive deterioration in body image per EORTC QLQ-MY20
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to definitive deterioration in future perspective per EORTC QLQ-MY20
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to definitive deterioration in EQ-5D-5L VAS
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to first improvement in GHS per EORTC QLQ-C30
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to first improvement in physical functioning per EORTC QLQ-C30
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to first improvement in role functioning per EORTC QLQ-C30
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to first improvement in pain per EORTC QLQ-C30
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to first improvement in fatigue per EORTC QLQ-C30
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to first improvement in disease symptoms per EORTC QLQ-MY20
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to first improvement in treatment side effects per EORTC QLQ-MY20
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to first improvement in body image per EORTC QLQ-MY20
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to first improvement in future perspective per EORTC QLQ-MY20
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Time to first improvement in EQ-5D-5L VAS
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Proportion with clinically meaningful improvement in GHS per EORTC QLQ-C30
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Proportion with clinically meaningful improvement in physical functioning per EORTC QLQ-C30
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Proportion with clinically meaningful improvement in role functioning per EORTC QLQ-C30
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Proportion with clinically meaningful improvement in pain per EORTC QLQ-C30
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Proportion with clinically meaningful improvement in fatigue per EORTC QLQ-C30
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Proportion with clinically meaningful improvement in disease symptoms per EORTC QLQ-MY20
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Proportion with clinically meaningful improvement in treatment side effects per EORTC QLQ-MY20
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Proportion with clinically meaningful improvement in body image per EORTC QLQ-MY20
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Proportion with clinically meaningful improvement in future perspective per EORTC QLQ-MY20
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Proportion of clinically meaningful improvement in EQ-5D-5L VAS
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Mean proportion of time with high side effect bother as measured by Functional Assessment of Cancer Therapy (FACIT)- Item Global Population 5 (GP5)
Time Frame: Up to 5 years
Phase 3 FACIT-Item GP5 will be used to assess the patient-reported impact of treatment toxicity that uses a single item "I am bothered by side effects of treatment" on a 5-point scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much).
Up to 5 years
Proportion of patients with high side effect bother as measured by FACIT- Item GP5
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Occurrence of Anti-Drug Antibody (ADA) to linvoseltamab in serum
Time Frame: Up to 5 years
Phase 3
Up to 5 years
Magnitude of ADA to linvoseltamab in serum
Time Frame: Up to 5 years
Phase 3
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regeneron Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 21, 2038

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 21, 2038

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R5458-HM-2504
  • 2025-524032-19-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing 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

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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