Linvoseltamab
DrugAdministered per the protocol
Other names: REGN5458, Lynozyfic™
NCT Number: NCT06140524
This study is researching an investigational drug called linvoseltamab ("study drug") in participants at moderate risk of developing multiple myeloma (about 3 to 10% average annual risk), a group that consists of patients with precancerous conditions called High-Risk Monoclonal Gammopathy of Undetermined Significance (HR-MGUS) and Non-High-Risk Smoldering Multiple Myeloma (NHR-SMM).
The primary purpose of the study is to understand how well the study drug can eliminate abnormal plasma cells and laboratory signs of HR-MGUS and NHR-SMM.
The study is looking at several other research questions, including:
* How many participants treated with linvoseltamab have improvement of their HR-MGUS or NHR-SMM? * 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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
AZ St.-Elisabeth Herentals vzw, Herentals, Antwerp, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria apply
Administered per the protocol
Other names: REGN5458, Lynozyfic™
Time frame: 35 days
Part 1 An AEI is a toxicity potentially related to study treatment that may preclude dose escalation or expansion according to the Bayesian Optimal Interval (BOIN) design decision rules
Time frame: 35 days
Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Time frame: 35 days
Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Time frame: Up to 5.5 years
Part 2
Time frame: Up to 5.5 years
As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Time frame: Up to 5.5 years
As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Time frame: Up to 5.5 years
Time frame: Up to 5.5 years
Time frame: Up to 5.5 years
As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Time frame: Up to 5.5 years
As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Time frame: Up to 5.5 years
Time frame: Up to 3 years after achievement of CR
Time frame: Up to 5.5 years
Time frame: Up to 5.5 years
Time frame: Up to 5.5 years
Time frame: Up to 9 months
Time frame: Up to 5.5. years
Time frame: Up to 5.5. years
Contact information is provided by the study sponsor or research team.
Regeneron Pharmaceuticals
Industry
Phase 2 Dose-Ranging and Interception Study of Linvoseltamab in Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma
Acronym: LINKER-MGUS1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06644625
Blood Protein Disorders, Cardiovascular Diseases
Charlotte, North Carolina, United States
View Trial DetailsNCT07214324
Blood Protein Disorders, Cardiovascular Diseases
Bologna, Italy
View Trial DetailsNCT02269592
B-cell Malignancy, Low-grade, Blood Protein Disorders
Boston, Massachusetts, United States
View Trial DetailsNCT05283993
Abnormalities, Multiple, Amyloidosis
Beijing, China
View Trial Details