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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004638-39 | EudraCT Number | ||
| 2023-506247-42-00 | EU Trial (CTIS) Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Linvoseltamab + Daratumumab | Experimental | Linvoseltamab + Daratumumab |
|
| Cohort 2: Linvolseltamab + Carfilzomib | Experimental | Linvoseltamab + Carfilzomib |
|
| Cohort 3: Linvoseltamab + Lenalidomide | Experimental | Linvoseltamab + Lenalidomide |
|
| Cohort 4: Linvoseltamab + Bortezomib | Experimental | Linvoseltamab + Bortezomib |
|
| Cohort 5: Linvoseltamab + Pomalidomide | Experimental | Linvoseltamab + Pomalidomide |
|
| Cohort 6: Linvoseltamab + Isatuximab | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linvoseltamab | Drug | Administered per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicities (DLTs) for each study regimen during the observation period | Dose finding portion only | Up to 28 Days |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Up to 5 Years | |
| Severity of TEAEs | Up to 5 Years | |
| Incidence of Serious Adverse Events (SAEs) | Up to 5 Years | |
| Severity of SAEs | Up to 5 Years | |
| Incidence of Adverse Events of Special Interest (AESIs) | Up to 5 Years | |
| Severity of AESIs | Up to 5 Years | |
| Incidence of laboratory abnormalities | ≥ grade 3 per National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE v5.0] | Up to 5 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) as measured by International Myeloma Working Group (IMWG) criteria | Up to 5 Years | |
| Duration of Response (DOR) by IMWG criteria | Up to 5 Years | |
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General Key Inclusion Criteria:
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:
General Key Exclusion Criteria:
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:
Cohort 8:
Cohort 9:
Cohort 10:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic Torrey Pines | Recruiting | La Jolla | California | 92037 | United States | |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has:
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
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Linvoseltamab + Isatuximab
|
| Cohort 7: Linvoseltamab + Fianlimab | Experimental | Linvoseltamab + Fianlimab |
|
| Cohort 8: Linvoseltamab + Cemiplimab | Experimental | Linvoseltamab + Cemiplimab |
|
| Cohort 9: Linvoseltamab + Nirogacestat | Experimental | Linvoseltamab + Nirogacestat |
|
| Cohort 10: Linvoseltamab + Cevostamab | Experimental | Linvoseltamab + Cevostamab |
|
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| Daratumumab | Drug | Administered per the protocol |
|
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| Carfilzomib | Drug | Administered per the protocol |
|
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| Lenalidomide | Drug | Administered per the protocol |
|
|
| Bortezomib | Drug | Administered per the protocol |
|
|
| Pomalidomide | Drug | Administered per the protocol |
|
|
| Isatuximab | Drug | Administered per the protocol |
|
|
| Fianlimab | Drug | Administered per the protocol |
|
|
| Cemiplimab | Drug | Administered per the protocol |
|
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| Nirogacestat | Drug | Administered per the protocol |
|
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| Cevostamab | Drug | Administered per the protocol |
|
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| Progression-Free Survival (PFS) as measured by IMWG criteria |
| Up to 5 Years |
| Rate of Minimal Residual Disease (MRD) negative status by IMWG criteria | Up to 5 Years |
| Concentrations of total linvoseltamab in serum over time | Up to 5 Years |
| Incidence over time of Anti-Drug Antibodies (ADAs) to linvoseltamab | Up to 5 Years |
| Overall Survival (OS) | Up to 5 Years |
| Winship Cancer Institute of Emory University |
| Recruiting |
| Atlanta |
| Georgia |
| 30004 |
| United States |
| Indiana University Health Simon Cancer Center | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Dana Farber/Harvard Cancer Center | Recruiting | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
| Weill Cornell Medicine/New York Presbyterian Hospital | Recruiting | New York | New York | 10021 | United States |
| New York Presbyterian Hospital Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
| Wake Forest University Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| The Ohio State University James Cancer Hospital | Recruiting | Columbus | Ohio | 43210 | United States |
| University of Texas Southwestern | Recruiting | Dallas | Texas | 75390 | United States |
| VA Puget Sound Health Care System | Recruiting | Seattle | Washington | 98108 | United States |
| Centre Hospitalier Universitaire (CHU) de Poitiers | Recruiting | Poitiers | New Aquitaine | 86021 | France |
| CHU de Lille - Rue Michel Polonovski | Suspended | Lille | Nord | 59037 | France |
| Nantes University Hospital | Recruiting | Nantes | Pays de la Loire Region | 44093 | France |
| Centre Hospitalier Universitaire Angers | Recruiting | Angers | 49933 | France |
| CHU Montpellier - Departement D'Hematologie | Recruiting | Montpellier | 34295 | France |
| Saint Antoine Hospital | Recruiting | Paris | 75571 | France |
| Institut Gustave Roussy | Recruiting | Villejuif | 94805 | France |
| Hospital Henri Mondor | Recruiting | Créteil | Île-de-France Region | 94000 | France |
| Saint Louis Hospital | Recruiting | Paris | Île-de-France Region | 75010 | France |
| Hopital Necker | Recruiting | Paris | Île-de-France Region | 75015 | France |
| Evangelismos General Hospital | Recruiting | Athens | Attica | 10676 | Greece |
| General Hospital of Athens Alexandra | Recruiting | Athens | 11528 | Greece |
| Sheba Medical Center | Recruiting | Ramat Gan | Central District | 5265601 | Israel |
| Rambam Health Care Campus | Recruiting | Haifa | 3109601 | Israel |
| Hadassah Medical Center | Recruiting | Jerusalem | 91120 | Israel |
| Hospital Clinico Universitario de Santiago | Recruiting | Santiago de Compostela | A Coruna | 15706 | Spain |
| Hospital Germans Trias i Pujol | Recruiting | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitario Marques de Valdecilla | Recruiting | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario Quiron Salud Madrid | Recruiting | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Clinica Universidad de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
| Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals, | Recruiting | Barcelona | 08908 | Spain |
| Universitaru Hospital La Princesa | Recruiting | Madrid | 28006 | Spain |
| Clinica Universidad de Navarra - Madrid | Recruiting | Madrid | 28027 | Spain |
| Hospital Universitario Ramon y Cajal - Servicio de Psiquiatria | Recruiting | Madrid | 28034 | Spain |
| University Hospital and Research Institute | Recruiting | Madrid | 28041 | Spain |
| Hospital Universitario HM Sanchinarro | Recruiting | Madrid | 28050 | Spain |
| University Hospital of Salamanca | Recruiting | Salamanca | 37007 | Spain |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C556306 | daratumumab |
| C524865 | carfilzomib |
| D000077269 | Lenalidomide |
| D000069286 | Bortezomib |
| C467566 | pomalidomide |
| C000599209 | isatuximab |
| C000627974 | cemiplimab |
| C550722 | nirogacestat |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
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