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NCT05955508Active, not recruitingPhase 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

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

Source: ClinicalTrials.gov · Last updated 13 Apr 2026

Brief summary (registry, in English)

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)

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
40 (actual)
First submitted
13 Jul 2023
Start date
30 Jan 2024
Primary completion date
25 Jan 2033
Lead sponsor
Regeneron Pharmaceuticals
NCT number
NCT05955508
EU CT number
2023-503524-11-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 40
  • From 30 Jan 2024 to the primary completion date, 25 Jan 2033
  • 17 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any infection requiring hospitalization or treatment with intravenous anti-infectives within 28 days of first dose of study drug

Other illness

  • 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)
  • Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol
  • 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
  • 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

Other

  • Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), soft tissue plasmacytoma, or symptomatic multiple myeloma

Who the study is looking for

  • High-risk SMM diagnosis within 5 years of study enrollment, as described in the protocol
  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Germans Trias i Pujol
Coordinator of this site? Confirm its status		BadalonaSpainUnknown status
Institut Catala d'Oncologia
Coordinator of this site? Confirm its status		BarcelonaSpainUnknown status
Hospital Clinic de Barcelona
Coordinator of this site? Confirm its status		BarcelonaSpainUnknown status
Hospital Clínico Universitario Virgen de la Arrixaca
Coordinator of this site? Confirm its status		El PalmarSpainUnknown status
University Hospital of Cabuenes
Coordinator of this site? Confirm its status		GijónSpainUnknown status
Hospital Universitario Virgen de las Nieves
Coordinator of this site? Confirm its status		GranadaSpainUnknown status
Hospital General Universitario Gregorio Maranon (HGUGM) - Instituto de Investigacion Sanitaria Gregorio Maranon
Coordinator of this site? Confirm its status		MadridSpainUnknown status
Hospital Universitario Ramón y Cajal
Coordinator of this site? Confirm its status		MadridSpainUnknown status
Clinica Universidad de Navarra Madrid
Coordinator of this site? Confirm its status		MadridSpainUnknown status
Hospital Universitari Son Llatzer
Coordinator of this site? Confirm its status		Palma MallorcaSpainUnknown status
Clinica Universidad de Navarra - Pamplona
Coordinator of this site? Confirm its status		PamplonaSpainUnknown status
Hospital Universitario Quiron Salud Madrid
Coordinator of this site? Confirm its status		Pozuelo de AlarcónSpainUnknown status
Hospital Clinico Universitario de Salamanca
Coordinator of this site? Confirm its status		SalamancaSpainUnknown status
Hospital Universitario Marqués de Valdecilla
Coordinator of this site? Confirm its status		SantanderSpainUnknown status
Hospital Clinico Universitario Santiago de Compostela
Coordinator of this site? Confirm its status		Santiago de CompostelaSpainUnknown status
La Fe University Hospital
Coordinator of this site? Confirm its status		ValenciaSpainUnknown status
University Hospital Doctor Peset
Coordinator of this site? Confirm its status		ValenciaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.