Phase 2 Study of Linvoseltamab in Patients With Smoldering Multiple Myeloma at High Risk of Progression to Multiple Myeloma

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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 your 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 continue to 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 your 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:

• High-risk SMM diagnosis within 5 years of study enrollment

• Eastern Cooperative Oncology Group (ECOG) performance status ≤1

• Adequate hematologic and hepatic function, as described in the protocol

• Estimated glomerular filtration rate ≥30 mL/min/1.73 m\^2

Locations
Other Locations
Spain
Hospital Germans Trias i Pujol
RECRUITING
Badalona
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Institut Catala d'Oncologia
RECRUITING
Barcelona
Hospital Clinico Universitario Virgen De La Arrixaca
RECRUITING
El Palmar
University Hospital of Cabuenes
RECRUITING
Gijon
Hospital Universitario Virgen de las Nieves
RECRUITING
Granada
Clinica Universidad de Navarra - Madrid
RECRUITING
Madrid
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Universitari Son Llatzer
RECRUITING
Palma Mallorca
Clinica Universidad de Navarra
RECRUITING
Pamplona
Hospital Universitario Quiron Salud Madrid
RECRUITING
Pozuelo De Alarcon
Hospital Clinico Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
Hospital Clinico Universitario Santiago de Compostela
RECRUITING
Santiago De Compostela
La Fe University Hospital
RECRUITING
Valencia
University Hospital Doctor Peset
RECRUITING
Valencia
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2024-01-30
Estimated Completion Date: 2032-12-19
Participants
Target number of participants: 40
Treatments
Experimental: Safety Run-In (Part 1)
Evaluation of initial safety and tolerability of the step-up regimen leading up to the start of full dose linvoseltamab.
Experimental: Expansion (Part 2)
Linvoseltamab monotherapy according to the same dosing schedule established in the safety run-in part.
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov