Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma
Condition(s) studied
Investigational drug(s) / intervention(s)
Linvoseltamab: Administered per the protocol
Study summary
The main purpose of this study is to learn about the safety of linvoseltamab and to find out what is the best dose of linvoseltamab to give to patients with multiple myeloma and to look for any signs that linvoseltamab can effectively treat cancer.
The study is looking at several other research questions, including:
* Side effects that may be experienced by people receiving linvoseltamab
* How linvoseltamab works in the body
* How much linvoseltamab is present in the blood
* How linvoseltamab may work to treat cancer
Eligibility
Primary outcome measure(s)
- Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period — Up to 28 days
Phase 1 and Phase 2 for Japanese cohort only - Incidence and severity of treatment-emergent adverse events (TEAEs) — Up to 5 years
Phase 1 - Incidence and severity of adverse events of special interest (AESI) — Up to 5 years
Phase 1 - Assessment of the pharmacokinetics (PK) of linvoseltamab — Up to 5 years
Phase 1 part 2 - Concentrations of linvoseltamab in serum over time — Up to 5 years
Phase 2, for Japanese cohort only - Objective response rate (ORR) as determined by an Independent Review Committee (IRC) — Up to 5 years
Phase 2, cohorts 1 and 2 - Incidence and severity of cytokine release syndrome (CRS) with linvoseltamab — Up to 5 years
Phase 2, cohort 3 - ORR of IV linvoseltamab as assessed by investigator — Up to 5 years
Phase 2, cohort 3
Trial sites (40)
| Facility | City | Region | Status |
|---|---|---|---|
| Sylvester Comprehensive Cancer Center | Miami | Florida | Active Not Recruiting |
| Moffitt Cancer Center - McKinley Drive | Tampa | Florida | Recruiting |
| Emory University Hospital | Atlanta | Georgia | Recruiting |
| Indiana University_Michigan Street | Indianapolis | Indiana | Active Not Recruiting |
| Norton Cancer Institute | Louisville | Kentucky | Recruiting |
| C. S. Mott_University of Michigan | Ann Arbor | Michigan | Active Not Recruiting |
| Barbara Ann Karmanos Cancer Center | Detroit | Michigan | Active Not Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | Active Not Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | Recruiting |
| Columbia University Medical Center | New York | New York | Active Not Recruiting |
| Ohio State University James Cancer Hospital | Columbus | Ohio | Recruiting |
| Oregon Health and Science University (OHSU) Marquam Hill Campus | Portland | Oregon | Recruiting |
| University of Texas MD Anderson Clinic | Houston | Texas | Active Not Recruiting |
| Swedish Cancer Institute | Seattle | Washington | Recruiting |
| ZNA Psychiatrisch Ziekenhuis Stuivenberg | Antwerp | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | Recruiting |
| Universitatsklinikum Essen | Essen | North Rhine-Westphalia | Completed |
| Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR | Mainz | Rhineland-Palatinate | Completed |
| Universitatsklinikum Wurzburg | Würzburg | Germany | Completed |
| Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital | Nagoya | Aichi-ken | Completed |
| Nagoya City University Hospital | Nagoya | Aichi-ken | Recruiting |
| National Cancer Center Hospital East | Kashiwa-shi | Chiba | Recruiting |
| Gunma University Hospital | Maebashi | Gunma | Recruiting |
| Ibaraki Prefectural Central Hospital | Kasama-shi | Ibaraki | Recruiting |
| University Hospital Kyoto Prefectural Univ of Medicine | Kyoto | Kyoto | Recruiting |
| Saitama Medical University International Medical Center | Hidaka | Saitama | Completed |
| Tokushima Prefectural Central Hospital | Tokushima | Tokushima | Recruiting |
| Japanese Red Cross Medical Center | Shibuya-ku | Tokyo | Completed |
| Keio University Hospital | Tokyo | Japan | Recruiting |
| National Cancer Center Korea | Goyang | South Korea | Recruiting |
| Seoul National University Cancer Hospital | Seoul | South Korea | Recruiting |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | South Korea | Recruiting |
| Yonsei University College of Medicine, Severance Hospital | Seoul | South Korea | Recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Catalonia | Recruiting |
| Clinica Universidad de Navarra | Pamplona | Navarre | Recruiting |
| Universitary Hospital La Princesa | Madrid | Salamanca | Recruiting |
| Hospital Universitario Ramon y Cajal | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Recruiting |
| Hospital Clinico Universitario de Salamanca | Salamanca | Spain | Recruiting |
| Royal Marsden Hospital | Sutton | Surrey | Withdrawn |
More Regeneron Pharmaceuticals trials in Japan
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03761108 on ClinicalTrials.gov ↗ ← All trials in Japan