AzTrials
AzTrials

Relapsed/Refractory Multiple Myeloma (RRMM)Phase 4POPLINNCT07609940

Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS)

A Phase 4 study testing Linvoseltamab and Tocilizumab in people with Relapsed/Refractory Multiple Myeloma (RRMM), run by Regeneron Pharmaceuticals at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Linvoseltamab and Tocilizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
7 sitesUnited States
Study dates
15 Jul 2026to 6 Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Disease progression on or after at least 4 prior lines of therapy including a(n) Protease Inhibitor (PI), Immunomodulatory imide Drug (IMiD), and anti-CD 38 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

Who cannot join

  • Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS) syndrome
  • Known myeloma brain lesions or meningeal involvement
  • History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy [PML], or Central Nervous System (CNS) movement disorder
  • NOTE: Other protocol defined inclusion/exclusion criteria apply

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

7 sites in 1 country

United States7 sites, 7 recruiting

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

    Recruiting

  • American Oncology Partners, PA dba The Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

    Recruiting

  • Berenson Cancer Center

    Los Angeles, California, 90069

    Recruiting

  • Texas Tech University Health Science Center School of Medicine

    Lubbock, Texas, 79430

    Recruiting

  • Renown Health Medical Oncology

    Reno, Nevada, 89502

    Recruiting

  • Comprehensive Hematology Oncology

    St. Petersburg, Florida, 33709

    Recruiting

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

    Recruiting

Other trials in United States

About this study

Official title: A Phase 4, Single-Arm, Multicenter Study of Prophylactic Tocilizumab in Participants With Relapsed/Refractory Multiple Myeloma Treated With Linvoseltamab in the Outpatient Setting

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.

Read more

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

  • What side effects may happen from taking tocilizumab before the first dose of linvoseltamab
  • Whether tocilizumab has an impact on CRS, including whether participants require hospital care and, if so, how many hospital visits occur and how long they last
  • How frequently other medications (for example, corticosteroids or additional doses of tocilizumab) are used to support participants' care if needed
Being tested
Linvoseltamab, Tocilizumab
Keywords
Cytokine Release Syndrome (CRS), Linvoseltamab, Tocilizumab, Bispecific antibodies
Medical subject headings
Multiple Myeloma, Cytokine Release Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LinvoseltamabDrug

    Also called REGN5458, Lynozyfic™

    Administered per the protocol

  • TocilizumabDrug

    Also called ACTEMRA®

    Administered per the protocol

Study groups in NCT07609940
Study groupRoleWhat they receive
LinvoseltamabExperimentalNot described
Receives: Drug: Linvoseltamab; Drug: Tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of any grade CRS per American Society for Transplantation and Cellular Therapy (ASTCT) grading

    Measured: Up to 28 days

  2. Severity of any grade CRS per ASTCT grading

    Measured: Up to 28 days

Secondary outcomes (30)

  1. Occurrence of CRS of any grade

    Measured: Up to 12 months

  2. Occurrence of recurrent CRS of any grade

    Measured: Up to 12 months

  3. Occurrence of grade ≥2 CRS per ASTCT grading

    Measured: Up to 12 months

  4. Occurrence of recurrent grade ≥2 CRS per ASTCT grading

    Measured: Up to 12 months

  5. 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

    Measured: Up to 12 months

  6. Occurrence of grade ≥3 infections per NCI-CTCAE version 5.0

    Measured: Up to 12 months

  7. Occurrence of any grade Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) per ASTCT grading

    Measured: Up to 12 months

  8. Occurrence of grade ≥3 ICANS per ASTCT grading

    Measured: Up to 12 months

  9. Occurrence of any grade neurotoxicity per NCI-CTCAE version 5.0 grading

    Measured: Up to 12 months

  10. Occurrence of any grade neurotoxicity per ASTCT grading

    Measured: Up to 12 months

  11. Occurrence of grade ≥3 neurotoxicity per NCI-CTCAE version 5.0 grading

    Measured: Up to 12 months

  12. Occurrence of grade ≥3 neurotoxicity per ASTCT grading

    Measured: Up to 12 months

  13. Occurrence of any grade neutropenia per NCI-CTCAE version 5.0 grading

    Measured: Up to 12 months

  14. Occurrence of grade ≥3 neutropenia per NCI-CTCAE version 5.0 grading

    Measured: Up to 12 months

  15. Number of treatment doses of tocilizumab following at least 1 dose of linvoseltamab for the management CRS

    Measured: Up to 12 months

  16. Number of treatment doses of corticosteroid following at least 1 dose of linvoseltamab for the management CRS

    Measured: Up to 12 months

  17. Total duration of corticosteroid treatment following at least 1 dose of linvoseltamab for the management CRS

    Measured: Up to 12 months

  18. Number of hospitalizations per participant treated with at least 1 dose of linvoseltamab

    Measured: Up to 12 months

  19. Total length of each Adverse Event (AE)-related hospital stay

    Measured: Up to 12 months

  20. Occurrence of Treatment-Emergent Adverse Events (TEAEs) in participants treated with at least 1 dose of linvoseltamab

    Measured: Up to 12 months

  21. Severity of TEAEs in participants treated with at least 1 dose of linvoseltamab

    Measured: Up to 12 months

  22. Occurrence of Adverse Events of Special Interest (AESI) in participants treated with at least 1 dose of linvoseltamab

    Measured: Up to 12 months

  23. Severity of AESI in participants treated with at least 1 dose of linvoseltamab

    Measured: Up to 12 months

  24. Occurrence of Serious Adverse Events (SAEs) in participants treated with at least 1 dose of linvoseltamab

    Measured: Up to 12 months

  25. Severity of SAEs in participants treated with at least 1 dose of linvoseltamab

    Measured: Up to 12 months

  26. Achievement of Partial Response or better (≥PR) per International Myeloma Working Group (IMWG) criteria

    Measured: Up to 12 months

  27. Duration Of Response (DOR)

    Measured: Up to 12 months

  28. Progression-Free Survival (PFS)

    Measured: Up to 12 months

  29. Overall Survival

    Measured: Up to 12 months

  30. Time To Response (TTR)

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2026
  2. Study start15 Jul 2026
  3. Primary completion11 Oct 2027 (estimated)
  4. Study completion6 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07609940
Sponsor's protocol ID
R5458-HM-2514
Acronym
POPLIN
Status last verified
Oct 2026
First submitted
20 May 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Linvoseltamab and Tocilizumab in people with Relapsed/Refractory Multiple Myeloma (RRMM), run by Regeneron Pharmaceuticals at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of any grade CRS per American Society for Transplantation and Cellular Therapy (ASTCT) grading (time frame: Up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07609940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in