A Phase 4 interventional study of Linvoseltamab and Tocilizumab in Relapsed/Refractory Multiple Myeloma (RRMM), sponsored by Regeneron Pharmaceuticals. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Regeneron Pharmaceuticals · Phase 4, Interventional, and Treatment
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Among 16 studies testing linvoseltamab in Multiple Myeloma — 13 open to participants now, 15 under way, 4 of them phase 3. linvoseltamab · Multiple Myeloma.
Among the 16 studies testing linvoseltamab in Multiple Myeloma, this one is the 14th largest by planned enrollment, is one of 7 that started in 2026, is the only one in phase 4, reaches primary completion later than 1 of the 14 other live ones, and was the 16th registered.
3,763 studies on the registry are indexed under Multiple Myeloma; 770 are open to participants now.
Browse Multiple Myeloma studies →13 of the 16 studies testing linvoseltamab in Multiple Myeloma are open now, in 12 countries. Recruiting first, the newest first:
Medical College of Wisconsin · Sites in United States
Ages 18+
Regeneron Pharmaceuticals · Sites in United States, France, Japan and 3 more countries
Ages 18+
Multiple Myeloma Research Consortium · Sites in United States
Ages 18+
Fred Hutchinson Cancer Center · Sites in United States
Ages 18+
Regeneron Pharmaceuticals · Sites in United States, Australia, Brazil and 5 more countries
Ages 18+
By country, each count listing its studies:
linvoseltamab: first FDA approval 2025 (LYNOZYFIC), first EMA approval 2025. What it is approved for, and how studies give it, is on its page →
Of the 585 Multiple Myeloma studies recruiting now, 430 (74%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 11 · Phase 3 5 · Phase 4 1
First in 2019; this study’s year is marked. 7 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 41 across 3,008 interventional studies indexed under Multiple Myeloma.
Median enrollment 168 across the 16 interventional studies. None of them has completed or been terminated yet.
This tab as a report to print or save as PDF → With an account.
10 of 16 have an industry lead sponsor. The 6 most frequent:
Regeneron Pharmaceuticals is the lead sponsor of 412 studies on the registry; 90 are open to participants now.
Of its 126 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.
15 studies in Multiple Myeloma by Regeneron Pharmaceuticals: 9 open now, 11 under way, 3 of them phase 3. Of 2 finished, 0 (0%) have results posted.
Among the 15 studies in Multiple Myeloma by Regeneron Pharmaceuticals, this one is the 12th largest by planned enrollment of the 13 interventional ones that give a count, is one of 5 that started in 2026, is the only one in phase 4, reaches primary completion later than 0 of the 10 other live ones, and was the 15th registered.
Regeneron Pharmaceuticals’s Multiple Myeloma studies by the year they started, since 2019.
2 of the studies testing linvoseltamab in Multiple Myeloma that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06376526Dickran Kazandjian, MDIMMUNOPLANT for Newly Diagnosed Multiple Myeloma | 2027-08-31 |
| NCT07609940Regeneron PharmaceuticalsAdult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS) | 2027-10-11 |
Add all 2 to your calendar (.ics) → With an account.
Among the 16 studies testing linvoseltamab in Multiple Myeloma, from their registry updates:
Among Regeneron Pharmaceuticals’s 15 in Multiple Myeloma:
Nothing recorded among them since 2026-09-25.
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This study is researching whether the use of tocilizumab before the first dose of linvoseltamab will decrease the risk of Cytokine Release Syndrome (CRS) in participants who have Relapsed or Refractory Multiple Myeloma (RRMM) who have already been treated with at least four lines of treatment for their multiple myeloma, including medicines called a proteasome inhibitor, an immunomodulatory drug, and an anti-Cluster of Differentiation (CD) 38 antibody.
The aim of the study is to see how safe, tolerable and effective linvoseltamab is when given after tocilizumab.
The study is looking at several other research questions, including:
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 line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Linvoseltamab · Drug: Tocilizumab
Administered per the protocol
Also known as: REGN5458, Lynozyfic™
Administered per the protocol
Also known as: ACTEMRA®
Occurrence of any grade CRS per American Society for Transplantation and Cellular Therapy (ASTCT) grading
Time frame: Up to 28 days
Severity of any grade CRS per ASTCT grading
Time frame: Up to 28 days
Occurrence of CRS of any grade
Time frame: Up to 12 months
Occurrence of recurrent CRS of any grade
Time frame: Up to 12 months
Occurrence of grade ≥2 CRS per ASTCT grading
Time frame: Up to 12 months
Occurrence of recurrent grade ≥2 CRS per ASTCT grading
Time frame: Up to 12 months
Occurrence of any grade infections per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
NCI CTCAE grade 1 to 5 version 5.0
Time frame: Up to 12 months
Occurrence of grade ≥3 infections per NCI-CTCAE version 5.0
Time frame: Up to 12 months
Occurrence of any grade Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) per ASTCT grading
Time frame: Up to 12 months
Occurrence of grade ≥3 ICANS per ASTCT grading
Time frame: Up to 12 months
Occurrence of any grade neurotoxicity per NCI-CTCAE version 5.0 grading
Time frame: Up to 12 months
Occurrence of any grade neurotoxicity per ASTCT grading
Time frame: Up to 12 months
Occurrence of grade ≥3 neurotoxicity per NCI-CTCAE version 5.0 grading
Time frame: Up to 12 months
Occurrence of grade ≥3 neurotoxicity per ASTCT grading
Time frame: Up to 12 months
Occurrence of any grade neutropenia per NCI-CTCAE version 5.0 grading
Time frame: Up to 12 months
Occurrence of grade ≥3 neutropenia per NCI-CTCAE version 5.0 grading
Time frame: Up to 12 months
Number of treatment doses of tocilizumab following at least 1 dose of linvoseltamab for the management CRS
Time frame: Up to 12 months
Number of treatment doses of corticosteroid following at least 1 dose of linvoseltamab for the management CRS
Time frame: Up to 12 months
Total duration of corticosteroid treatment following at least 1 dose of linvoseltamab for the management CRS
Time frame: Up to 12 months
Number of hospitalizations per participant treated with at least 1 dose of linvoseltamab
Time frame: Up to 12 months
Total length of each Adverse Event (AE)-related hospital stay
Time frame: Up to 12 months
Occurrence of Treatment-Emergent Adverse Events (TEAEs) in participants treated with at least 1 dose of linvoseltamab
Time frame: Up to 12 months
Severity of TEAEs in participants treated with at least 1 dose of linvoseltamab
Time frame: Up to 12 months
Occurrence of Adverse Events of Special Interest (AESI) in participants treated with at least 1 dose of linvoseltamab
Time frame: Up to 12 months
Severity of AESI in participants treated with at least 1 dose of linvoseltamab
Time frame: Up to 12 months
Occurrence of Serious Adverse Events (SAEs) in participants treated with at least 1 dose of linvoseltamab
Time frame: Up to 12 months
Severity of SAEs in participants treated with at least 1 dose of linvoseltamab
Time frame: Up to 12 months
Achievement of Partial Response or better (≥PR) per International Myeloma Working Group (IMWG) criteria
Time frame: Up to 12 months
Duration Of Response (DOR)
Time frame: Up to 12 months
Progression-Free Survival (PFS)
Time frame: Up to 12 months
Overall Survival
Time frame: Up to 12 months
Time To Response (TTR)
Time frame: Up to 12 months
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 Jul 2026 (actual). Primary completion is estimated for Oct 2027, 14 months after the start.
Of 28 phase 4 interventional studies under Multiple Myeloma, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 57. This study's planned 14 months is below that.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Linvoseltamab · Tocilizumab