A Phase 3 interventional study of Linvoseltamab and Daratumumab in High Risk Smoldering Multiple Myeloma (HR-SMM), sponsored by Regeneron Pharmaceuticals. Recruiting at 33 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment
This study is researching an experimental drug called linvoseltamab (also called "study drug") compared to another drug called daratumumab, in participants with Smoldering Multiple Myeloma (SMM), who are at a High Risk (HR) of developing active multiple myeloma.
The aim of this study is to find out whether linvoseltamab is better than daratumumab in delaying the development of MM.
The study is looking at several other research questions, including:
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 270 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Linvoseltamab
Drug: Daratumumab
Administered per the protocol
Also known as: REGN5458, Lynozyfic™
Administered per the protocol
Also known as: Darzalex Faspro®, Darzalex®
Clinical Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) criteria
Time frame: Up to 5 years
Biochemical PFS per IMWG criteria
Time frame: Up to 5 years
Achievement of Minimal Residual Disease (MRD) Complete Response (CR) at 10^-5 per IMWG criteria
Time frame: Up to 3 years
Time to death
Time frame: Up to 9 years
Overall Response Rate (ORR) of Partial Response or better (≥PR) per IMWG criteria
Time frame: Up to 3 years
Best Overall Response (BOR) per IMWG criteria
Time frame: Up to 3 years
Achievement of MRD-negativity
Time frame: Up to 3 years
Sustained MRD-negativity
Time frame: Up to 3 years
Duration of MRD-negative CR
Time frame: Up to 3 years
Duration Of Response (DOR) per IMWG criteria
Time frame: Up to 5 years
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 3 years
Severity of TEAEs
Time frame: Up to 3 years
Occurrence of Serious Adverse Events (SAEs)
Time frame: Up to 3 years
Change from baseline score in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) scale
The EORTC QLQ-C30 is a 30-item validated questionnaire developed to measure patient-reported QoL using 1 GHS/QoL scale, 5 functioning scales (physical, role, emotional, cognitive and social) and 9 symptom scales / items (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) among patients with cancer. For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 5 = "excellent" with higher scores indicating better functioning and positive changes from baseline indicate improvement.
Time frame: Up to 5 years
Change from baseline score in EORTC QLQ-C30 physical functioning scale
Time frame: Up to 5 years
Change from baseline score in EORTC QLQ-C30 role functioning scale
Time frame: Up to 5 years
Change from baseline score in EORTC QLQ-C30 emotional functioning scale
Time frame: Up to 5 years
Change from baseline score in EORTC QLQ-C30 pain scale
The EORTC QLQ-C30 is a 30-item validated questionnaire developed to measure patient-reported QoL using 1 GHS/QoL scale, 5 functioning scales (physical, role, emotional, cognitive and social) and 9 symptom scales / items (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) among patients with cancer. For the 9 symptom scales, scores range from 1 = "not at all" to 9 = "very much" higher scores indicate higher symptom burden and negative changes from baseline indicate improvement.
Time frame: Up to 5 years
Change from baseline score in EORTC QLQ-C30 fatigue scale
Time frame: Up to 5 years
Change from baseline score in EORTC IL478 future perspectives scale
EORTC IL478 corresponds to the EORTC QLQ-Multiple Myeloma Module 20 (MY20) future Perspective Scale. This is a is a self-administered instrument to assess QoL in persons with MM. For the future perspective 3 items are analyzed. A high score for an item represents a high level of symptomatic problem.
Time frame: Up to 5 years
Change from baseline score in EuroQoL-5 Dimensions 5-Level Questionnaire Visual Analogue Scale (EQ-5D-5L VAS )
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".
Time frame: Up to 5 years
Functional Assessment of Cancer Therapy (FACIT)- Item Global Population 5 (GP5) responses
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).
Time frame: Up to 5 years
Change from baseline in FACIT- Item GP5 score
Time frame: Up to 5 years
Concentrations of linvoseltamab in serum
Time frame: Up to 5 years
Occurrence of Anti-Drug Antibodies (ADAs) to linvoseltamab in serum
Time frame: Up to 5 years
Magnitude of ADA to linvoseltamab in serum
Time frame: Up to 5 years
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Jul 2033, 86 months after the start.
Of 107 industry-sponsored phase 3 interventional studies under Multiple Myeloma, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 66. This study's planned 86 months is above that.
Counting every sponsor, half of 178 studies reached it within 56 months; a quarter within 35 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Linvoseltamab