This study is researching an investigational drug called linvoseltamab ("study drug") in participants at high risk of developing Multiple Myeloma (MM), a group commonly labeled as High-Risk Smoldering Multiple Myeloma (HR-SMM). The aim of the study is to understand the safety and tolerability (how the body reacts to linvoseltamab) as well as the effectiveness (how well linvoseltamab eliminates plasma cells and prevents the development of MM) of the study drug. There are 2 parts to the study. * In Part 1, linvoseltamab will be given to a small number of participants to study the early side effects (safety) of the study drug and make sure the treatment is acceptable. * In Part 2, linvoseltamab will be given to more participants to further assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat HR-SMM and prevent progression to MM. The study is looking at several other research questions, including: * How many participants treated with linvoseltamab (study drug) have improvement of their HR-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 linvoseltamab less effective or could lead to side effects)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Administered per the protocol
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna, Spain
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain
Hospital Universitari Son Llatzer
Palma Mallorca, Balearic Islands, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Quiron Salud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Clinico Universitario Virgen De La Arrixaca
El Palmar, Murcia, Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, Navarre, Spain
University Hospital of Cabuenes
Gijón, Principality of Asturias, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
...and 7 more locations
Frequency of Adverse Events of Special Interest (AESI) during the safety run-in observation period
AESI include grade 2 or higher Cytokine Release Syndrome (CRS) and Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Time frame: Up to 35 days
Frequency of Treatment-Emergent Adverse Events (TEAEs) during the safety run-in observation period
Time frame: Up to 35 days
Severity of TEAEs during the safety run-in observation period
Time frame: Up to 35 days
Complete Response (CR) as determined by the investigator
Time frame: Up to 7 years
Minimal Residual Disease (MRD) negativity
Time frame: At 12 months
MRD negativity
Time frame: At 24 months
Frequency of TEAEs during expansion part
As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Time frame: Up to 7 years
Severity of TEAEs during expansion part
As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Time frame: Up to 7 years
Frequency of Serious Adverse Events (SAEs)
Time frame: Up to 7 years
Severity of SAEs
Time frame: Up to 7 years
Frequency of laboratory abnormalities
Time frame: Up to 7 years
Severity of laboratory abnormalities
Time frame: Up to 7 years
Overall response of Partial Response (PR) or better
Time frame: Up to 7 years
Duration Of Response (DOR)
Time frame: Up to 7 years
Biochemical Progression-Free-Survival (PFS)
Time frame: Up to 7 years
MRD negativity among participants that achieve Very Good Partial Response (VGPR) or better
Time frame: Up to 3 years after end of treatment
Sustained MRD negativity
Time frame: Up to 3 years after end of treatment
Time from treatment initiation to date of any myeloma-defining event
Time frame: Up to 7 years
Time from start of treatment to date of progression to MM or death
Time frame: Up to 7 years
Time to initiation of first-line treatment for MM
Time frame: Up to 7 years
Overall Survival (OS)
Time frame: Up to 7 years
Concentration of linvoseltamab in serum
Time frame: Up to 2 years
Incidence of Anti-Drug Antibodies (ADAs) to linvoseltamab
Time frame: Up to 2 years
Magnitude of ADAs to linvoseltamab
Time frame: Up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.