An Open-Label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab Plus Carfilzomib Versus Standard of Care Combination Regimens in Patients With Relapsed/Refractory Multiple Myeloma
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participant with RRMM who received at least 1 but not more than 3 prior lines of therapy, which must have included treatment with lenalidomide and either a Protease Inhibitor (PI) or anti-CD38 monoclonal antibody
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
• Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy
Locations
United States
Georgia
Emory Winship Cancer Institute
RECRUITING
Atlanta
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
OhioHealth
RECRUITING
Columbus
Texas
University of Texas Health Science Center, Houston
RECRUITING
Houston
Other Locations
Australia
Mater Misericordiae Ltd
RECRUITING
Brisbane
Alfred Hospital
RECRUITING
Melbourne
Gold Coast Hospital and Health Service
RECRUITING
Southport
Republic of Korea
Chonnam National University Hwasun Hospital
RECRUITING
Hwasun
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Seoul St. Mary's Hospital, The Catholic University of Korea
RECRUITING
Seoul
Severance Hospital; Division of Hematology
RECRUITING
Seoul
Ulsan University Hospital
RECRUITING
Ulsan
United Kingdom
Aberdeen Royal Infirmary
RECRUITING
Aberdeen
University Hospitals Birmingham NHS Trust, Center for Clinical
RECRUITING
Birmingham
Ninewells Hospital and Medical School
RECRUITING
Dundee
Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust
RECRUITING
Norwich
University Hospitals Plymouth National Health Service (NHS) Foundation Trust - Hematology
RECRUITING
Plymouth
Royal Cornwall Hospital National Health Service (NHS) Foundation Trust