Multiple MyelomaPhase 1NCT05137054
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
A Phase 1 study testing Linvoseltamab, Daratumumab and Carfilzomib in people with Multiple Myeloma, run by Regeneron Pharmaceuticals at 42 sites in 5 countries.
Trial summary
This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Linvoseltamab, Daratumumab and Carfilzomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 42 sitesin 5 countries
- Study dates
- 17 Aug 2022to 24 Mar 2032
- Phase
- Phase 1
- 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
General Key Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Participants must have measurable disease as defined in the protocol according to IMWG consensus criteria
- Adequate creatinine clearance, hematologic function and hepatic function, as defined in protocol
- Life expectancy of at least 6 months
Cohort Specific Inclusion Criteria:
For cohorts 1-6, each participant must have RRMM with progression following at least 3 lines of therapy, or at least 2 lines of therapy and either prior exposure to at least 1 anti-CD38 antibody, 1 immunomodulatory imide drug (IMiD) and 1 Proteasome Inhibitor (PI), or double-refractory to 1 PI and 1 IMiD, or the combination of 1 PI and 1 IMiD Cohort 1: Prior treatment with daratumumab is allowed if previously tolerated, as described in the protocol Cohort 2: Prior treatment with carfilzomib is allowed if previously tolerated at the approved full dose, as described in the protocol Cohort 3: Prior treatment with lenalidomide is allowed if previously tolerated at the approved full dose, as described in the protocol Cohort 4: Prior treatment with bortezomib is allowed if previously tolerated at the approved full dose, as described in the protocol Cohort 5: Prior treatment with pomalidomide is allowed if previously tolerated at the approved full dose, as described in the protocol Cohort 6: Prior treatment with isatuximab is allowed if previously tolerated, as described in the protocol
Cohort 7 and 8:
- For participants without measurable disease by biochemical parameters [serum or urine M-protein, or serum involved Free Light Chain (FLC)], presence of at least 1 soft tissue plasmacytoma with a single diameter of ≥2 cm
- RRMM with progressive disease and received at least 3 lines of therapy including exposure to at least 1 anti-CD38 antibody, 1 IMiD, and 1 PI or triple-class refractory disease (anti-CD38 antibody, IMiD, PI) Cohort 9: Progressive RRMM in participants with triple-class refractory disease (anti-CD38 antibody, IMiD, PI) after at least 3 lines of therapy Cohort 10: Progressive RRMM after at least 3 lines of therapy including exposure to at least 1 anti-CD38 antibody, 1 IMiD, and 1 PI
General Key Exclusion Criteria:
- Diagnosis of plasma cell leukemia, primary light-chain amyloidosis (excluding myeloma associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes)
- Participants with known MM brain lesions or meningeal involvement
- Treatment with any systemic anti-myeloma therapy within 5 half-lives or within 21 days prior to first administration of study drug regimen, whichever is shorter
- History of allogeneic and autologous stem cell transplantation, as described in the protocol
- Unless stated otherwise in a specific sub-protocol, prior treatment with a T cell-based immunotherapy directed against B-Cell Maturation Antigen (BCMA) bispecific antibodies and Bispecific T-cell Engagers (BiTEs), and BCMA Chimeric Antigen Receptor (CAR) T cells (Note: BCMA antibody-drug conjugates are not excluded)
- History of progressive multifocal leukoencephalopathy, neurodegenerative condition or Central Nervous System (CNS) movement disorder or participants with a history of seizure within 12 months prior to study enrollment are excluded
- Live or attenuated vaccination within 28 days prior to first study drug regimen administration with a vector that has replicative potential
- Cardiac ejection fraction <40% by Echocardiogram (Echo) or Multigated Acquisition (MUGA) scan
Cohort Specific Exclusion Criteria:
Cohort 2: Dose expansion: Prior treatment with a BCMA-directed CAR T-cell therapy will not be exclusionary if completed at least 12 weeks prior to first study treatment Cohort 3: Known malabsorption syndrome or pre-existing gastrointestinal (GI) condition that may impair absorption of lenalidomide; delivery of lenalidomide via nasogastric tube or gastrostomy tube is not allowed Cohort 4: Peripheral neuropathy grade ≥2 Cohort 5: Known malabsorption syndrome or pre-existing GI conditions that may impair absorption of pomalidomide; delivery of pomalidomide via nasogastric tube or gastrostomy tube is not allowed
Cohort 7:
- Prior treatment with anti-Lymphocyte Activation Gene 3 (LAG-3) agents. Prior exposure to vaccine therapies or other immune checkpoint modulating therapies such as anti-Programmed cell Death Protein 1 (PD-1) antibodies is permitted, as described in the protocol
- Ongoing or recent (within 2 years) evidence of an autoimmune disease that has required systemic treatment with immunosuppressive agents, as described in the protocol
- Prior solid organ transplant
- History of grade ≥3 immune-mediated adverse events (with the exclusion of endocrinopathies that are fully controlled by hormone replacement) from prior checkpoint inhibitor therapies
Cohort 8:
- Prior treatment with anti-PD-1 or anti-PD-L1 agents. Prior exposure to vaccine therapies or other immune checkpoint modulating therapies such as anti-Cytotoxic T Lymphocyte-Associated Antigen 4 (CTLA-4) antibodies is permitted, as described in the protocol
- Encephalitis or meningitis in the year prior to enrollment
- History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to enrollment
- Ongoing or recent (within 2 years) evidence of an autoimmune disease that has required systemic treatment with immunosuppressive agents, as described in the protocol.
- Prior solid organ transplant
- History of grade ≥3 immune-mediated adverse events (with the exclusion of endocrinopathies that are fully controlled by hormone replacement) from prior checkpoint inhibitor therapies
Cohort 9:
- Abnormal QT interval corrected by Fridericia's formula (QTcF), as described in the protocol
- Use of concomitant medications that are known to prolong the QT/QTcF interval including Class Ia and Class III antiarrhythmics at the time of informed consent
- Ongoing use or anticipated use of food or drugs that are known strong/moderate cytochrome P450 (CYP)3A4 inhibitors, or strong CYP3A inducers within 14 days prior to first dose of nirogacestat
- Known malabsorption syndrome or existing gastrointestinal GI condition that may impair absorption of nirogacestat; delivery of nirogacestat via nasogastric tube or gastrostomy tube is not allowed
Cohort 10:
- Known or suspected active Epstein-Barr Virus (EBV) infection
- Known history of Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS)
- Prior treatment with cevostamab or another agent with the same target [Fragment crystallizable Receptor-like 5 (FcRH5)]
Dose finding portion: Prior treatment with any BCMA-directed immunotherapy will not be exclusionary, as described in the protocol Dose expansion portion: Prior treatment with any T cell-engaging bispecific antibody directed against BCMA will be exclusionary, as described in the protocol
NOTE: Other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
42 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
42 sites in 5 countries
Spain14 sites, 14 recruiting
- Recruiting
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
- Recruiting
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals,
Barcelona, 08908
- Recruiting
Universitaru Hospital La Princesa
Madrid, 28006
- Recruiting
Clinica Universidad de Navarra - Madrid
Madrid, 28027
- Recruiting
Hospital Universitario Ramon y Cajal - Servicio de Psiquiatria
Madrid, 28034
- Recruiting
University Hospital and Research Institute
Madrid, 28041
- Recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
- Recruiting
Hospital Universitario Quiron Salud Madrid
Pozuelo de Alarcón, Madrid, 28223
- Recruiting
University Hospital of Salamanca
Salamanca, 37007
- Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
- Recruiting
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruna, 15706
United States13 sites, 13 recruiting
- Recruiting
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30004
- Recruiting
Dana Farber/Harvard Cancer Center
Boston, Massachusetts, 02215
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
- Recruiting
The Ohio State University James Cancer Hospital
Columbus, Ohio, 43210
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
- Recruiting
Indiana University Health Simon Cancer Center
Indianapolis, Indiana, 46202
- Recruiting
Scripps Clinic Torrey Pines
La Jolla, California, 92037
- Recruiting
Weill Cornell Medicine/New York Presbyterian Hospital
New York, New York, 10021
- Recruiting
New York Presbyterian Hospital Columbia University Medical Center
New York, New York, 10032
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
VA Puget Sound Health Care System
Seattle, Washington, 98108
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
France10 sites, 10 recruiting
- Recruiting
Centre Hospitalier Universitaire Angers
Angers, 49933
- Recruiting
Hospital Henri Mondor
Créteil, Île-de-France Region, 94000
- Recruiting
CHU de Lille - Rue Michel Polonovski
Lille, Nord, 59037
- Recruiting
CHU Montpellier - Departement D'Hematologie
Montpellier, 34295
- Recruiting
Nantes University Hospital
Nantes, Pays de la Loire Region, 44093
- Recruiting
Saint Antoine Hospital
Paris, 75571
- Recruiting
Saint Louis Hospital
Paris, Île-de-France Region, 75010
- Recruiting
Hopital Necker
Paris, Île-de-France Region, 75015
- Recruiting
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, New Aquitaine, 86021
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
Israel3 sites, 3 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, 3109601
- Recruiting
Hadassah Medical Center
Jerusalem, 91120
- Recruiting
Sheba Medical Center
Ramat Gan, Central District, 5265601
Greece2 sites, 2 recruiting
- Recruiting
Evangelismos General Hospital
Athens, Attica, 10676
- Recruiting
General Hospital of Athens Alexandra
Athens, 11528
About this study
Official title: Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma
This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior therapies and needed to be treated again.
In the initial study, some participants treated with linvoseltamab had improvement of their myeloma, including complete responses (no evidence of myeloma in their bodies).
Read more
This study is the first time linvoseltamab will be combined with other cancer therapies.
The main goal is to understand if linvoseltamab can be given safely with other cancer treatments, and if so, what dose of linvoseltamab should be used for each combination.
The study is looking at several other research questions, including:
- How many participants treated with linvoseltamab in combination with each of the other cancer treatments have improvement of their multiple myeloma
- What side effects may happen from taking linvoseltamab together with another cancer treatment
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)
- Conditions
- Multiple Myeloma
- Being tested
- Linvoseltamab, Daratumumab, Carfilzomib, Lenalidomide, Bortezomib
- Keywords
- Relapsed/Refractory Multiple Myeloma (RRMM), B-cell maturation antigen (BCMA), Anti-CD3 monoclonal antibodies (mAbs)
- Medical subject headings
- Multiple Myeloma
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
DaratumumabDrug
Also called Darzalex®; Darzalex Faspro™
Administered per the protocol
CarfilzomibDrug
Also called Kyprolis®
Administered per the protocol
LenalidomideDrug
Also called Revlimid®
Administered per the protocol
BortezomibDrug
Also called Velcade®
Administered per the protocol
PomalidomideDrug
Also called Imnovid, Pomalyst®
Administered per the protocol
IsatuximabDrug
Also called Sarclisa®
Administered per the protocol
FianlimabDrug
Also called REGN3767
Administered per the protocol
CemiplimabDrug
Also called LIBTAYO, REGN2810
Administered per the protocol
NirogacestatDrug
Also called PF-03084014
Administered per the protocol
CevostamabDrug
Also called BFCR4350A, RO7187797
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Linvoseltamab + Daratumumab | Experimental | Linvoseltamab + Daratumumab Receives: Drug: Linvoseltamab; Drug: Daratumumab |
| Cohort 2: Linvoseltamab + Carfilzomib | Experimental | Linvoseltamab + Carfilzomib Receives: Drug: Linvoseltamab; Drug: Carfilzomib |
| Cohort 3: Linvoseltamab + Lenalidomide | Experimental | Linvoseltamab + Lenalidomide Receives: Drug: Linvoseltamab; Drug: Lenalidomide |
| Cohort 4: Linvoseltamab + Bortezomib | Experimental | Linvoseltamab + Bortezomib Receives: Drug: Linvoseltamab; Drug: Bortezomib |
| Cohort 5: Linvoseltamab + Pomalidomide | Experimental | Linvoseltamab + Pomalidomide Receives: Drug: Linvoseltamab; Drug: Pomalidomide |
| Cohort 6: Linvoseltamab + Isatuximab | Experimental | Linvoseltamab + Isatuximab Receives: Drug: Linvoseltamab; Drug: Isatuximab |
| Cohort 7: Linvoseltamab + Fianlimab | Experimental | Linvoseltamab + Fianlimab Receives: Drug: Linvoseltamab; Drug: Fianlimab |
| Cohort 8: Linvoseltamab + Cemiplimab | Experimental | Linvoseltamab + Cemiplimab Receives: Drug: Linvoseltamab; Drug: Cemiplimab |
| Cohort 9: Linvoseltamab + Nirogacestat | Experimental | Linvoseltamab + Nirogacestat Receives: Drug: Linvoseltamab; Drug: Nirogacestat |
| Cohort 10: Linvoseltamab + Cevostamab | Experimental | Linvoseltamab + Cevostamab Receives: Drug: Linvoseltamab; Drug: Cevostamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLTs) for each study regimen during the observation period
Dose finding portion only
Measured: Up to 28 Days
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to 5 Years
Severity of TEAEs
Measured: Up to 5 Years
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 5 Years
Severity of SAEs
Measured: Up to 5 Years
Incidence of Adverse Events of Special Interest (AESIs)
Measured: Up to 5 Years
Severity of AESIs
Measured: Up to 5 Years
Incidence of laboratory abnormalities
≥ grade 3 per National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE v5.0]
Measured: Up to 5 Years
Secondary outcomes (7)
Overall Response Rate (ORR) as measured by International Myeloma Working Group (IMWG) criteria
Measured: Up to 5 Years
Duration of Response (DOR) by IMWG criteria
Measured: Up to 5 Years
Progression-Free Survival (PFS) as measured by IMWG criteria
Measured: Up to 5 Years
Rate of Minimal Residual Disease (MRD) negative status by IMWG criteria
Measured: Up to 5 Years
Concentrations of total linvoseltamab in serum over time
Measured: Up to 5 Years
Incidence over time of Anti-Drug Antibodies (ADAs) to linvoseltamab
Measured: Up to 5 Years
Overall Survival (OS)
Measured: Up to 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start17 Aug 2022
- Primary completion25 Mar 2028 (estimated)
- Study completion24 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 317 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
- NCT05137054
- Sponsor's protocol ID
- R5458-ONC-2012
- Other IDs
- 2020-004638-39, 2023-506247-42-00, 2023
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2021
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05137054
- Acronym / sponsor ID
- R5458-ONC-2012
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed/Refractory Multiple Myeloma (RRMM), B-cell maturation antigen (BCMA), Anti-CD3 monoclonal antibodies (mAbs)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 317 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 25 Mar 2028 (estimated)
- Study completion
- 24 Mar 2032 (estimated)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior therapies and needed to be treated again.
In the initial study, some participants treated with linvoseltamab had improvement of their myeloma, including complete responses (no evidence of myeloma in their bodies).
This study is the first time linvoseltamab will be combined with other cancer therapies.
The main goal is to understand if linvoseltamab can be given safely with other cancer treatments, and if so, what dose of linvoseltamab should be used for each combination.
The study is looking at several other research questions, including:
- How many participants treated with linvoseltamab in combination with each of the other cancer treatments have improvement of their multiple myeloma
- What side effects may happen from taking linvoseltamab together with another cancer treatment
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Linvoseltamab + Daratumumab | Experimental | Drug: Linvoseltamab, Drug: DaratumumabLinvoseltamab + Daratumumab |
| Cohort 2: Linvoseltamab + Carfilzomib | Experimental | Drug: Linvoseltamab, Drug: CarfilzomibLinvoseltamab + Carfilzomib |
| Cohort 3: Linvoseltamab + Lenalidomide | Experimental | Drug: Linvoseltamab, Drug: LenalidomideLinvoseltamab + Lenalidomide |
| Cohort 4: Linvoseltamab + Bortezomib | Experimental | Drug: Linvoseltamab, Drug: BortezomibLinvoseltamab + Bortezomib |
| Cohort 5: Linvoseltamab + Pomalidomide | Experimental | Drug: Linvoseltamab, Drug: PomalidomideLinvoseltamab + Pomalidomide |
| Cohort 6: Linvoseltamab + Isatuximab | Experimental | Drug: Linvoseltamab, Drug: IsatuximabLinvoseltamab + Isatuximab |
| Cohort 7: Linvoseltamab + Fianlimab | Experimental | Drug: Linvoseltamab, Drug: FianlimabLinvoseltamab + Fianlimab |
| Cohort 8: Linvoseltamab + Cemiplimab | Experimental | Drug: Linvoseltamab, Drug: CemiplimabLinvoseltamab + Cemiplimab |
| Cohort 9: Linvoseltamab + Nirogacestat | Experimental | Drug: Linvoseltamab, Drug: NirogacestatLinvoseltamab + Nirogacestat |
| Cohort 10: Linvoseltamab + Cevostamab | Experimental | Drug: Linvoseltamab, Drug: CevostamabLinvoseltamab + Cevostamab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LinvoseltamabAlso: REGN5458, Lynozyfic™Administered per the protocol | Drug | Cohort 10: Linvoseltamab + Cevostamab, Cohort 1: Linvoseltamab + Daratumumab, Cohort 2: Linvoseltamab + Carfilzomib, Cohort 3: Linvoseltamab + Lenalidomide, Cohort 4: Linvoseltamab + Bortezomib, Cohort 5: Linvoseltamab + Pomalidomide, Cohort 6: Linvoseltamab + Isatuximab, Cohort 7: Linvoseltamab + Fianlimab, Cohort 8: Linvoseltamab + Cemiplimab, Cohort 9: Linvoseltamab + Nirogacestat |
| DaratumumabAlso: Darzalex®; Darzalex Faspro™Administered per the protocol | Drug | Cohort 1: Linvoseltamab + Daratumumab |
| CarfilzomibAlso: Kyprolis®Administered per the protocol | Drug | Cohort 2: Linvoseltamab + Carfilzomib |
| LenalidomideAlso: Revlimid®Administered per the protocol | Drug | Cohort 3: Linvoseltamab + Lenalidomide |
| BortezomibAlso: Velcade®Administered per the protocol | Drug | Cohort 4: Linvoseltamab + Bortezomib |
| PomalidomideAlso: Imnovid, Pomalyst®Administered per the protocol | Drug | Cohort 5: Linvoseltamab + Pomalidomide |
| IsatuximabAlso: Sarclisa®Administered per the protocol | Drug | Cohort 6: Linvoseltamab + Isatuximab |
| FianlimabAlso: REGN3767Administered per the protocol | Drug | Cohort 7: Linvoseltamab + Fianlimab |
| CemiplimabAlso: LIBTAYO, REGN2810Administered per the protocol | Drug | Cohort 8: Linvoseltamab + Cemiplimab |
| NirogacestatAlso: PF-03084014Administered per the protocol | Drug | Cohort 9: Linvoseltamab + Nirogacestat |
| CevostamabAlso: BFCR4350A, RO7187797Administered per the protocol | Drug | Cohort 10: Linvoseltamab + Cevostamab |
Primary outcome
Incidence of Dose Limiting Toxicities (DLTs) for each study regimen during the observation period
Time frame: Up to 28 Days
Dose finding portion only
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 5 Years
Severity of TEAEs
Time frame: Up to 5 Years
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 5 Years
Severity of SAEs
Time frame: Up to 5 Years
Incidence of Adverse Events of Special Interest (AESIs)
Time frame: Up to 5 Years
Severity of AESIs
Time frame: Up to 5 Years
Incidence of laboratory abnormalities
Time frame: Up to 5 Years
≥ grade 3 per National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE v5.0]
7 secondary outcomes
Overall Response Rate (ORR) as measured by International Myeloma Working Group (IMWG) criteria
Time frame: Up to 5 Years
Duration of Response (DOR) by IMWG criteria
Time frame: Up to 5 Years
Progression-Free Survival (PFS) as measured by IMWG criteria
Time frame: Up to 5 Years
Rate of Minimal Residual Disease (MRD) negative status by IMWG criteria
Time frame: Up to 5 Years
Concentrations of total linvoseltamab in serum over time
Time frame: Up to 5 Years
Incidence over time of Anti-Drug Antibodies (ADAs) to linvoseltamab
Time frame: Up to 5 Years
Overall Survival (OS)
Time frame: Up to 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
42 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Linvoseltamab, Daratumumab and Carfilzomib in people with Multiple Myeloma, run by Regeneron Pharmaceuticals at 42 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Spain, United States, France, Israel, Greece. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of Dose Limiting Toxicities (DLTs) for each study regimen during the observation period (time frame: Up to 28 Days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.