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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507809-34-00 | EU Trial (CTIS) Number |
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This study is researching an experimental drug called linvoseltamab ("study drug").
This study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again.
The study consists of 2 phases (Phase 1 and Phase 2):
The study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Cohort 1: Low Dose | Experimental | Dose Escalation: Non-Randomized |
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| Phase 1: Cohort 2: High Dose | Experimental | Dose Escalation: Non-Randomized |
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| Phase 2: Low Dose | Experimental | Dose Expansion: Participants will be randomized in a 1:1 ratio |
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| Phase 2: High Dose | Experimental | Dose Expansion: Participants will be randomized in a 1:1 ratio |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linvoseltamab | Drug | anti-B-cell maturation antigen x anti-Cluster of differentiation 3 bispecific antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicity (DLTs) | Phase 1 | Up to 28 Days |
| Achievement of hematologic complete response (CR) as determined by the Independent Review Committee (IRC) | Phase 2 | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of hematologic CR, as determined by the IRC | Phase 1 | Up to 3 years |
| Achievement of hematologic very good partial response (VGPR) or better response (CR + VGPR), as determined by the IRC |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States | |
| Colorado Blood Cancer Institute/SCRI |
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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Note: Participants enrolled in Phase 2 will be randomized 1:1
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|
| Up to 3 years |
| Achievement of overall hematologic response (PR or better), as determined by the IRC | Up to 3 years |
| Time to initial hematologic response | Up to 3 years |
| Time to best hematologic response | Up to 3 years |
| Duration of hematologic response (ie, best response, VGPR or better, overall response), as determined by the IRC | Up to 7 years |
| Hematologic progression-free survival (PFS) | Up to 7 years |
| Incidence of death | Up to 7 years |
| Incidence of treatment-emergent adverse events (TEAEs) | Up to 39 months |
| Severity of TEAEs | Up to 39 months |
| Incidence of serious adverse events (SAEs) | Up to 39 months |
| Severity of SAEs | Up to 39 months |
| Incidence of adverse events of special interest (AESIs) | Up to 39 months |
| Severity of AESIs | Up to 39 months |
| Achievement of overall hematologic response (PR or better), as determined by the IRC in dose regimen 1 vs 2 | Phase 2 | Up to 39 months |
| Incidence of TEAEs in dose regimen 1 vs 2 | Phase 2 | Up to 39 months |
| Severity of TEAEs in dose regimen 1 vs 2 | Phase 2 | Up to 39 months |
| Incidence of SAEs in dose regimen 1 vs 2 | Phase 2 | Up to 39 months |
| Severity of SAEs in dose regimen 1 vs 2 | Phase 2 | Up to 39 months |
| Incidence of AESIs in dose regimen 1 vs 2 | Phase 2 | Up to 39 months |
| Severity of AESIs in dose regimen 1 vs 2 | Phase 2 | Up to 39 months |
| Time from treatment initiation to hematologic disease progression as determined by the IRC | Up to 7 years |
| Time from treatment initiation to cardiac deterioration, as determined by the IRC | Up to 7 years |
| Time from treatment initiation to kidney deterioration as determined by the IRC | Up to 7 years |
| Time from treatment initiation to death as determined by the IRC | Up to 7 years |
| Time from initiation of treatment to date of death from any cause | Up to 7 years |
| Achievement of renal response in participants with renal involvement at baseline, as determined by IRC | Up to 7 years |
| Achievement of cardiac response in participants with cardiac involvement at baseline, as determined by IRC | Up to 7 years |
| Time to first renal response in participants with renal involvement at baseline | Up to 7 years |
| Time to first cardiac response in participants with cardiac involvement at baseline | Up to 7 years |
| Linvoseltamab concentration in serum over time | Up to 39 months |
| Incidence of anti-drug antibodies (ADAs) to linvoseltamab over time | Up to 39 months |
| Titers of ADAs to linvoseltamab over time | Up to 39 months |
| Recruiting |
| Denver |
| Colorado |
| 80218 |
| United States |
| Boston Medical Center | Recruiting | Boston | Massachusetts | 02118 | United States |
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
| Roswell Park Comprehensive Cancer Center | Recruiting | Buffalo | New York | 14263 | United States |
| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| National and Kapodistrian University of Athens | Recruiting | Athens | 11528 | Greece |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Seoul St. Mary's Hospital - The Catholic University of Korea | Recruiting | Seoul | 065791 | South Korea |
| Hospital Universitari Son Espases | Recruiting | Palma | Balearic Islands | 07120 | Spain |
| Clinica Universidad de Navarra - Pamplona | Recruiting | Pamplona | Navarre | 31008 | Spain |
| Hospital de Cabuenes | Recruiting | Gijón | Principality of Asturias | 33203 | Spain |
| Universität de Barcelona- Institut d' Investigacions Biomediques August Pi i Sunyer (IDIBAPS) | Recruiting | Barcelona | 08036 | Spain |
| University Hospital La Fe | Recruiting | Valencia | 46026 | Spain |
| University College London Hospitals | Recruiting | London | NW1 2PG | United Kingdom |
| The Christie NHS Foundation Trust | Withdrawn | Manchester | M20 4BQ | United Kingdom |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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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