ClinicalTrials.gg
Sign In
RecruitingNCT07222761LINKER-MM5Updated Nov 4, 2026

A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

A Phase 3 interventional study of Linvoseltamab and Carfilzomib in Relapsed and/or Refractory Multiple Myeloma (RRMM), sponsored by Regeneron Pharmaceuticals. Recruiting at 53 sites in 8 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

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Updated Nov 4, 2026First sites in Brazil, Chile and Turkey (Türkiye)29 sites addedGo to Updates ↓

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 3
Study type
Interventional
Enrollment
915
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 16 studies testing linvoseltamab in Multiple Myeloma — 13 open to participants now, 15 under way, 4 of them phase 3. linvoseltamab · Multiple Myeloma.

Planned enrollment
2nd of 16
915 · median 168
Started
2026
with 6 others
Phase 3
4 of 16
4 open now
Primary completion
2029-05
later than 5 of 14 live
Registered
13th of 16
by date
Lead sponsor
10 of 16
Regeneron Pharmaceuticals

Among the 16 studies testing linvoseltamab in Multiple Myeloma, this one is the 2nd largest by planned enrollment, is one of 7 that started in 2026, is one of 4 in phase 3, reaches primary completion later than 5 of the 14 other live ones, and was the 13th registered.

Multiple Myeloma

3,763 studies on the registry are indexed under Multiple Myeloma; 770 are open to participants now.

Browse Multiple Myeloma studies →

Open to participants now

13 of the 16 studies testing linvoseltamab in Multiple Myeloma are open now, in 12 countries. Recruiting first, the newest first:

7 more — sign in →

By country, each count listing its studies:

United States11
United Kingdom6
Korea, Republic of5
Australia4
Spain4
Germany3
Japan3
Taiwan3
Belgium2
Brazil2
Chile2
France2

All 13 open studies →

About linvoseltamab

linvoseltamab: first FDA approval 2025 (LYNOZYFIC), first EMA approval 2025. What it is approved for, and how studies give it, is on its page →

Who these studies take

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.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies testing linvoseltamab in Multiple Myeloma, or all of them as a file.
02

Study summary

This study is researching a drug called linvoseltamab (also called "study drug") either given alone or in combination with another anti-myeloma drug called carfilzomib, compared to several standard treatments for progressive Multiple Myeloma (MM) after at least 1 but no more than 3 prior therapies.

The aim of this study is to see if the safety and efficacy of linvoseltamab alone or in combination with carfilzomib can deliver better outcomes (deeper and longer responses that help extend life) than standard treatment options.

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

  • What side effects may happen from taking the study drug
  • How much study drug is in the blood at different times
  • Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
03

Conditions studied

  • Relapsed and/or Refractory Multiple Myeloma (RRMM)

Browse trials for

Keywords

  • BCMA X CD3 Bispecific Monoclonal Antibody
  • Bispecific combination therapy
  • Linvoseltamab
  • Carfilzomib
  • Proteasome inhibitor
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Participant with RRMM who received at least 1 but not more than 3 , which must have included treatment with lenalidomide and either a Protease Inhibitor (PI) or anti-CD38 monoclonal antibody
  2. (ECOG) performance status score ≤2
  3. Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy

Key Exclusion Criteria:

  1. Prior treatment with a T cell-based immunotherapy targeting BCMA, including BCMA-directed bispecific antibodies, Bispecific T-cell Engagers (BiTEs), and Chimeric Antigen Receptor (CAR) T cells. Antibody-drug conjugates targeting BCMA (eg, belantamab mafodotin) are not excluded
  2. Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  3. Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement
  4. History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder

NOTE: Other protocol defined inclusion/exclusion criteria apply

Terms in these criteria, in plain language(2)

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.

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.

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.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
915 participants (estimated)

Study arms

  • Experimental
    Part 1: Arm A

    Drug: Linvoseltamab

  • Experimental
    Part 1: Arm B

    Drug: Linvoseltamab · Drug: Carfilzomib

  • Experimental
    Part 2: Arm A

    Drug: Linvoseltamab

  • Experimental
    Part 2: Arm B

    Drug: Linvoseltamab · Drug: Carfilzomib

  • Experimental
    Part 2: Arm C

    Drug: Carfilzomib · Drug: Daratumumab · Drug: Dexamethasone · Drug: Pomalidomide · Drug: Bortezomib

Interventions

  • DrugLinvoseltamab

    Administered per the protocol

    Also known as: REGN5458, Lynozyfic™

  • DrugCarfilzomib

    Administered per the protocol

    Also known as: Kyprolis®

  • DrugDaratumumab

    Administered per the protocol

    Also known as: Darzalex Faspro®, Darzalex®

  • DrugDexamethasone

    Administered per the protocol

    Also known as: Dexahexal®

  • DrugPomalidomide

    Administered per the protocol

    Also known as: Imnovid®, Pomalyst®

  • DrugBortezomib

    Administered per the protocol

    Also known as: Velcade®

06

What researchers measure

Primary outcomes

  1. Occurrence of Treatment Emergent Adverse Events (TEAEs)

    Part 1

    Time frame: Up to 5 years

  2. Severity of TEAEs

    Part 1

    Time frame: Up to 5 years

  3. Occurrence of Adverse Events of Special Interest (AESI)

    Part 1

    Time frame: Up to 5 years

  4. Severity of AESIs

    Part 1

    Time frame: Up to 5 years

  5. Occurrence of Serious Adverse Events (SAEs)

    Part 1

    Time frame: Up to 5 years

  6. Severity of SAEs

    Part 1

    Time frame: Up to 5 years

  7. Minimal Residual Disease (MRD)-negative Complete Response (CR)

    Part 2

    Time frame: At 12 months

  8. Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC

    Part 2

    Time frame: Up to 5 years

Secondary outcomes

  1. Occurrence of grade ≥2 Cytokine Release Syndrome (CRS)

    Part 1

    Time frame: Up to 28 days

  2. Timing of grade ≥2 CRS

    Part 1

    Time frame: Up to 28 days

  3. Overall Survival (OS)

    Part 2

    Time frame: Up to 7 years

  4. Achievement of Partial Response (PR) or better per IMWG response criteria as determined by BIRC

    Part 2

    Time frame: Up to 5 years

  5. Achievement of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by BIRC

    Part 2

    Time frame: Up to 5 years

  6. Achievement of CR or better per IMWG response criteria as determined by BIRC

    Part 2

    Time frame: Up to 5 years

  7. Duration Of Response (DOR) as per IMWG response criteria

    Part 2

    Time frame: Up to 5 years

  8. Time To Progression (TTP) as per IMWG response criteria

    Part 2

    Time frame: Up to 5 years

  9. Time To Next Treatment (TTNT)

    Part 2

    Time frame: Up to 5 years

  10. Second PFS

    Part 2

    Time frame: Up to 5 years

  11. MRD-negative CR criteria at any time

    Part 2

    Time frame: Up to 5 years

  12. Time to PR IMWG response category

    Part 2

    Time frame: Up to 5 years

  13. Time to VGPR IMWG response category

    Part 2

    Time frame: Up to 5 years

  14. Time to CR IMWG response category

    Part 2

    Time frame: Up to 5 years

  15. Time to stringent Complete Response (sCR) IMWG response category

    Part 2

    Time frame: Up to 5 years

  16. Sustained MRD-negative CR

    Part 2

    Time frame: Up to 5 years

  17. Duration of MRD-negative CR

    Part 2

    Time frame: Up to 5 years

  18. Occurrence of TEAEs

    Part 2

    Time frame: Up to 5 years

  19. Severity of TEAEs

    Part 2

    Time frame: Up to 5 years

  20. Occurrence of AESIs

    Part 2

    Time frame: Up to 5 years

  21. Severity of AESIs

    Part 2

    Time frame: Up to 5 years

  22. Occurrence of SAEs

    Part 2

    Time frame: Up to 5 years

  23. Severity of SAEs

    Part 2

    Time frame: Up to 5 years

  24. Concentrations of linvoseltamab in serum over time

    Part 2

    Time frame: Up to 5 years

  25. Incidence of Antidrug Antibodies (ADAs) to linvoseltamab

    Part 2

    Time frame: Up to 5 years

  26. Magnitude of ADAs to linvoseltamab

    Part 2

    Time frame: Up to 5 years

  27. Concentrations total soluble B-cell Maturation Antigen (sBCMA) in serum over time

    Part 2

    Time frame: Up to 5 years

  28. Change from baseline in Global Health Status (GHS)/Quality of Life (QoL), per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

    Part 2 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. Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."

    Time frame: Up to 5 years

  29. Change from baseline in Physical Functioning (PF), per EORTC QLQ-C30

    Part 2

    Time frame: Up to 5 years

  30. Change from baseline in Role Functioning (RF), per EORTC QLQ-C30

    Part 2

    Time frame: Up to 5 years

  31. Change from baseline in pain, per EORTC QLQ-C30

    Part 2

    Time frame: Up to 5 years

  32. Change from baseline in fatigue, per EORTC QLQ-C30

    Part 2

    Time frame: Up to 5 years

  33. Change in patient reported Disease Symptoms (DS) per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20])

    Part 2 EORTC QLQ-MY20 is an accompanying 20-item validated questionnaire that measure quality of life among patients living with MM across 4 scales (disease symptoms, side effect of treatment, body image and future perspective). A high score represents a high level of symptoms or problems.

    Time frame: Up to 5 years

  34. Change in patient reported Treatment Side Effects (TSE) per EORTC QLQ-MY20

    Part 2

    Time frame: Up to 5 years

  35. Change in patient-reported health state per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) Visual Analogue Scale (VAS)

    Part 2 The EQ-5D-5L is a generic questionnaire that measures HRQoL across 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) across 5 levels (no problems, slight problems, some problems, severe problems and extreme problems) and a VAS of pain (where 0: no pain and 10: worst pain), higher scores indicate higher pain.

    Time frame: Up to 5 years

  36. Change in patient-reported overall impact of treatment per Functional Assessment of Chronic Illness Therapy (FACIT) item GP5

    Part 2 FACIT Item GP5 is a recommended item by the Federal Drug Administration (FDA) in its recent draft guidance for cancer trials to assess patient-reported overall impact of treatment toxicity. It 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

07

Study locations

53 of 53 sites recruiting
08

References and documents

Individual participant data

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.

09

Timeline

4 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for May 2029, 40 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 30 and three quarters within 66. This study's planned 40 months is below that.

Counting every sponsor, half of 178 studies reached it within 55 months; a quarter within 34 and three quarters within 95.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 28, 2025
First posted
Oct 30, 2025
StartActual
Jan 2, 2026
Primary completionEst.
May 21, 2029
CompletionEst.
Aug 23, 2034
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
29 sites added — first sites in Brazil, Chile and Turkey (Türkiye)
Show 29 added (10 Brazil, 5 Chile, 4 Australia, 4 Turkey (Türkiye), 3 Taiwan, 2 United Kingdom, 1 United States)
  • Pindara Private Hospital · Benowa, Australia
  • Centro Gaucho Integrado, Hospital Mae de Deus · Porto Alegre, Brazil
  • OncoPrecision · Santiago, Chile
  • National Taiwan University Hospital · Taipei, Taiwan
  • Cetus Oncologia · Belo Horizonte, Brazil
  • Hospital Erasto Gaertner · Curitiba, Brazil
  • Oncomed Clinica Oncologica · Niterói, Brazil
  • Hospital de Clinicas de Porto Alegre · Porto Alegre, Brazil
  • ANIMI · Lages, Brazil
  • Unidade de Pesquisa Clinica (UPC); Hospital das Clinicas de Ribeirao Preto da Universidade de Sao Paulo · Ribeirão Preto, Brazil
  • AC Camargo Cancer Center · São Paulo, Brazil
  • Hospital Clinico Universidad de Los Andes · Santiago, Chile
  • Clinica Alemana de Santiago · Santiago, Chile
  • Clinica UC San Carlos de Apoquindo · Santiago, Chile
  • Centro de Investigaciones Clinicas Vina del Mar · Viña del Mar, Chile
  • Austin Hospital · Heidelberg, Australia
  • Clinica Medica Sao Germano · São Paulo, Brazil
  • Taipei Municipal Wan Fang Hospital · Taipei, Taiwan
  • The Royal Marsden National Health Service (NHS) Foundation Trust; Royal Marsden Hospital · Sutton, United Kingdom
  • University of Manchester, Manchester Royal Infirmary · Manchester, United Kingdom
  • Stony Brook University Hospital · Stony Brook, United States
  • Epworth Freemasons · East Melbourne, Australia
  • Royal Adelaide Hospital · Adelaide, Australia
  • Centro de Hematologia e Oncologia · Joinville, Brazil
  • Chang Gung Memorial Hospital - Linkou Branch · Taoyuan, Taiwan
  • Ankara University Faculty of Medicine · Mamak, Turkey (Türkiye)
  • Ankara Liv Hospital · Ankara, Turkey (Türkiye)
  • Istanbul Florence Nightingale Hospital · Istanbul, Turkey (Türkiye)
  • Izmir Ekonomi Universitesi (IEU) Medical Point Izmir Hastanesi (Izmir Economy University Medical Point Izmir Hospital) · Izmir, Turkey (Türkiye)
across 4 updates, Sep 29, 2026 – Nov 4, 2026
Show all 4 updates
  1. Nov 4, 2026
    9 sites added — first site in Turkey (Türkiye)
    Show 9 added (4 Turkey (Türkiye), 2 Australia, 1 United States, 1 Brazil, 1 Taiwan)
    • Stony Brook University Hospital · Stony Brook, United States
    • Epworth Freemasons · East Melbourne, Australia
    • Royal Adelaide Hospital · Adelaide, Australia
    • Centro de Hematologia e Oncologia · Joinville, Brazil
    • Chang Gung Memorial Hospital - Linkou Branch · Taoyuan, Taiwan
    • Ankara University Faculty of Medicine · Mamak, Turkey (Türkiye)
    • Ankara Liv Hospital · Ankara, Turkey (Türkiye)
    • Istanbul Florence Nightingale Hospital · Istanbul, Turkey (Türkiye)
    • Izmir Ekonomi Universitesi (IEU) Medical Point Izmir Hastanesi (Izmir Economy University Medical Point Izmir Hospital) · Izmir, Turkey (Türkiye)
    + 1 other change: verification date
  2. Oct 21, 2026
    5 sites added
    Show 5 added (2 United Kingdom, 1 Australia, 1 Brazil, 1 Taiwan)
    • Austin Hospital · Heidelberg, Australia
    • Clinica Medica Sao Germano · São Paulo, Brazil
    • Taipei Municipal Wan Fang Hospital · Taipei, Taiwan
    • The Royal Marsden National Health Service (NHS) Foundation Trust; Royal Marsden Hospital · Sutton, United Kingdom
    • University of Manchester, Manchester Royal Infirmary · Manchester, United Kingdom
  3. Oct 8, 2026
    11 sites added
    Show 11 added (7 Brazil, 4 Chile)
    • Cetus Oncologia · Belo Horizonte, Brazil
    • Hospital Erasto Gaertner · Curitiba, Brazil
    • Oncomed Clinica Oncologica · Niterói, Brazil
    • Hospital de Clinicas de Porto Alegre · Porto Alegre, Brazil
    • ANIMI · Lages, Brazil
    • Unidade de Pesquisa Clinica (UPC); Hospital das Clinicas de Ribeirao Preto da Universidade de Sao Paulo · Ribeirão Preto, Brazil
    • AC Camargo Cancer Center · São Paulo, Brazil
    • Hospital Clinico Universidad de Los Andes · Santiago, Chile
    • Clinica Alemana de Santiago · Santiago, Chile
    • Clinica UC San Carlos de Apoquindo · Santiago, Chile
    • Centro de Investigaciones Clinicas Vina del Mar · Viña del Mar, Chile
    + 1 other change: verification date
  4. Sep 29, 2026
    4 sites added — first sites in Brazil and Chile
    Show 4 added (1 Australia, 1 Brazil, 1 Chile, 1 Taiwan)
    • Pindara Private Hospital · Benowa, Australia
    • Centro Gaucho Integrado, Hospital Mae de Deus · Porto Alegre, Brazil
    • OncoPrecision · Santiago, Chile
    • National Taiwan University Hospital · Taipei, Taiwan

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 ↗

10

Registry details

Key details

Study ID
NCT07222761
Lead sponsor
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 30, 2025
Start date
Jan 2, 2026
Primary completion
May 21, 2029 (estimated)
Completion
Aug 23, 2034 (estimated)
Last update
Nov 4, 2026

Study contacts

Clinical Trials Administrator
Contact
clinicaltrials@regeneron.com
844-734-6643
Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Linvoseltamab · Carfilzomib

Other studies in this condition

Multiple Myeloma →

Other studies from this sponsor

Regeneron Pharmaceuticals →

Start the discussion