A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma

Last updated: December 18, 2024
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Multiple Myeloma

Cancer/tumors

Bone Neoplasm

Treatment

Linvoseltamab

Clinical Study ID

NCT05955508
R5458-ONC-2256
2023-503524-11-00
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

KEY Inclusion Criteria:

  1. High-risk SMM diagnosis within 5 years of study enrollment

  2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1

  3. Adequate hematologic and hepatic function, as described in the protocol

  4. Estimated glomerular filtration rate ≥30 mL/min/1.73 m^2

Exclusion

KEY Exclusion Criteria:

  1. Evidence of myeloma defining events *SLiM CRAB, as described in the protocol

*SLiM (greater than or equal to Sixty percent clonal plasma cells in the bonemarrow, involved/uninvolved free Light chain ratio of ≥100 with the involved freelight chain (FLC) being ≥100 mg/L, MRI with >1 focal lesion) CRAB (hyperCalcemia,Renal insufficiency, Anemia, or lytic Bone lesions)

  1. Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), soft tissue plasmacytoma, or symptomatic multiplemyeloma

  2. Clinically significant cardiac or vascular disease within 3 months of studyenrollment, as described in the protocol

  3. Any infection requiring hospitalization or treatment with IV anti-infectives within 28 days of first dose of study drug

  4. Uncontrolled human immunodeficiency virus (HIV), hepatitis B virus (HBV), orhepatitis C virus (HCV) infection; or other uncontrolled infection or unexplainedsigns of infection

  5. History of severe allergic reaction attributed to compounds with a similar chemicalor biologic composition as the study drug or excipient

NOTE: Other protocol defined inclusion/exclusion criteria apply

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Linvoseltamab
Phase: 2
Study Start date:
January 30, 2024
Estimated Completion Date:
December 19, 2032

Connect with a study center

  • Hospital Clinico Universitario Santiago de Compostela

    Santiago de Compostela, A Coruna 15706
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de las Nieves

    Granada, Andalusia 18014
    Spain

    Active - Recruiting

  • University Hospital of Cabuenes

    Gijon, Asturias 33203
    Spain

    Active - Recruiting

  • Hospital Universitari Son Llatzer

    Palma Mallorca, Baleares 07198
    Spain

    Active - Recruiting

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Active - Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Hospital Universitario Quiron Salud Madrid

    Pozuelo de Alarcon, Madrid 28223
    Spain

    Active - Recruiting

  • Hospital Universitario Quiron Salud Madrid

    Pozuelo de Alarcón, Madrid 28223
    Spain

    Site Not Available

  • Hospital Clinico Universitario Virgen De La Arrixaca

    El Palmar, Murcia 30120
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Paploma

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Institut Catala d'Oncologia

    Barcelona, 08908
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Madrid

    Madrid, 28027
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Hospital Universitario de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • La Fe University Hospital

    Valencia, 46026
    Spain

    Active - Recruiting

  • University Hospital Doctor Peset

    Valencia, 46017
    Spain

    Active - Recruiting

  • University Hospital La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

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