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 5 sites in United States.
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
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma (RRMM)
- What is being tested?
- Linvoseltamab and Tocilizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Jul 2026to 6 Dec 2028
- Phase
- Phase 4
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
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- 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
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33709
- Recruiting
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
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 group | Role | What they receive |
|---|---|---|
| Linvoseltamab | Experimental | Not described Receives: Drug: Linvoseltamab; Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any grade CRS per American Society for Transplantation and Cellular Therapy (ASTCT) grading
Measured: Up to 28 days
Severity of any grade CRS per ASTCT grading
Measured: Up to 28 days
Secondary outcomes (30)
Occurrence of CRS of any grade
Measured: Up to 12 months
Occurrence of recurrent CRS of any grade
Measured: Up to 12 months
Occurrence of grade ≥2 CRS per ASTCT grading
Measured: Up to 12 months
Occurrence of recurrent grade ≥2 CRS per ASTCT grading
Measured: 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
Measured: Up to 12 months
Occurrence of grade ≥3 infections per NCI-CTCAE version 5.0
Measured: Up to 12 months
Occurrence of any grade Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) per ASTCT grading
Measured: Up to 12 months
Occurrence of grade ≥3 ICANS per ASTCT grading
Measured: Up to 12 months
Occurrence of any grade neurotoxicity per NCI-CTCAE version 5.0 grading
Measured: Up to 12 months
Occurrence of any grade neurotoxicity per ASTCT grading
Measured: Up to 12 months
Occurrence of grade ≥3 neurotoxicity per NCI-CTCAE version 5.0 grading
Measured: Up to 12 months
Occurrence of grade ≥3 neurotoxicity per ASTCT grading
Measured: Up to 12 months
Occurrence of any grade neutropenia per NCI-CTCAE version 5.0 grading
Measured: Up to 12 months
Occurrence of grade ≥3 neutropenia per NCI-CTCAE version 5.0 grading
Measured: Up to 12 months
Number of treatment doses of tocilizumab following at least 1 dose of linvoseltamab for the management CRS
Measured: Up to 12 months
Number of treatment doses of corticosteroid following at least 1 dose of linvoseltamab for the management CRS
Measured: Up to 12 months
Total duration of corticosteroid treatment following at least 1 dose of linvoseltamab for the management CRS
Measured: Up to 12 months
Number of hospitalizations per participant treated with at least 1 dose of linvoseltamab
Measured: Up to 12 months
Total length of each Adverse Event (AE)-related hospital stay
Measured: Up to 12 months
Occurrence of Treatment-Emergent Adverse Events (TEAEs) in participants treated with at least 1 dose of linvoseltamab
Measured: Up to 12 months
Severity of TEAEs in participants treated with at least 1 dose of linvoseltamab
Measured: Up to 12 months
Occurrence of Adverse Events of Special Interest (AESI) in participants treated with at least 1 dose of linvoseltamab
Measured: Up to 12 months
Severity of AESI in participants treated with at least 1 dose of linvoseltamab
Measured: Up to 12 months
Occurrence of Serious Adverse Events (SAEs) in participants treated with at least 1 dose of linvoseltamab
Measured: Up to 12 months
Severity of SAEs in participants treated with at least 1 dose of linvoseltamab
Measured: Up to 12 months
Achievement of Partial Response or better (≥PR) per International Myeloma Working Group (IMWG) criteria
Measured: Up to 12 months
Duration Of Response (DOR)
Measured: Up to 12 months
Progression-Free Survival (PFS)
Measured: Up to 12 months
Overall Survival
Measured: Up to 12 months
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.
- First posted27 May 2026
- Study start15 Jul 2026
- Primary completion11 Oct 2027 (estimated)
- Study completion6 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple Myeloma (RRMM)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609940
- Sponsor's protocol ID
- R5458-HM-2514
- Acronym
- POPLIN
- Status last verified
- Sep 2026
- First submitted
- 20 May 2026
- Last updated
- 25 Sep 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.