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Clinical Trials in Spain / NCT05955508
Active, not recruiting Phase 2

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

NCT05955508 · tracked via the Priya Life Science Spain tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 2
Started
2024-01-30
Last updated
2026-04-13

Condition(s) studied

Smoldering Multiple Myeloma (SMM)

Investigational drug(s) / intervention(s)

Linvoseltamab →

Linvoseltamab: Administered per the protocol

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 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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: 1. High-risk SMM diagnosis within 5 years of study enrollment, as described in the protocol 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 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 bone marrow, involved/uninvolved free Light chain ratio of ≥100 with the involved free light chain (FLC) being ≥100 mg/L, MRI with \>1 focal lesion) CRAB (hyperCalcemia, Renal insufficiency, Anemia, or lytic Bone lesions) 2. Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), soft tissue plasmacytoma, or symptomatic multiple myeloma 3. Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol 4. Any infection requiring hospitalization or treatment with intravenous anti-infectives within 28 days of first dose of study drug 5. Uncontrolled Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection; or other uncontrolled infection or unexplained signs of infection, as described in the protocol 6. History of severe allergic reaction attributed to compounds with a similar chemical or biologic composition as the study drug or excipient NOTE: Other protocol defined inclusion/exclusion criteria apply

Primary outcome measure(s)

  • Frequency of Adverse Events of Special Interest (AESI) during the safety run-in observation period — Up to 35 days
    AESI include grade 2 or higher Cytokine Release Syndrome (CRS) and Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS)
  • Frequency of Treatment-Emergent Adverse Events (TEAEs) during the safety run-in observation period — Up to 35 days
  • Severity of TEAEs during the safety run-in observation period — Up to 35 days
  • Complete Response (CR) as determined by the investigator — Up to 7 years
  • Minimal Residual Disease (MRD) negativity — At 12 months
  • MRD negativity — At 24 months

Trial sites (17)

FacilityCityRegionStatus
Hospital Clinico Universitario Santiago de Compostela Santiago de Compostela A Coruna
Hospital Universitario Virgen de las Nieves Granada Andalusia
Hospital Universitari Son Llatzer Palma Mallorca Balearic Islands
Hospital Germans Trias i Pujol Badalona Barcelona
Hospital Universitario Marques de Valdecilla Santander Cantabria
Hospital Universitario Quiron Salud Madrid Pozuelo de Alarcón Madrid
Hospital Clinico Universitario Virgen De La Arrixaca El Palmar Murcia
Clinica Universidad de Navarra - Pamplona Pamplona Navarre
University Hospital of Cabuenes Gijón Principality of Asturias
Hospital Clinic de Barcelona Barcelona Spain
Institut Catala d'Oncologia Barcelona Spain
Hospital General Universitario Gregorio Maranon (HGUGM) - Instituto de Investigacion Sanitaria Gregorio Maranon Madrid Spain
Clinica Universidad de Navarra - Madrid Madrid Spain
Hospital Universitario Ramon y Cajal Madrid Spain
Hospital Clinico Universitario de Salamanca Salamanca Spain
University Hospital Doctor Peset Valencia Spain
La Fe University Hospital Valencia Spain

More Regeneron Pharmaceuticals trials in Spain

A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies Active, not recruiting
Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma Active, not recruiting
A Study to Evaluate How Pozelimab + Cemdisiran Combination Therapy Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Whose Current Treatment is Not Working Efficiently Recruiting
A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment Active, not recruiting
A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Active, not recruiting

Other trials for the same condition

A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05955508 on ClinicalTrials.gov ↗ ← All trials in Spain