Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a single drug hold off multiple myeloma? new trial aims to find out

NCT ID NCT05955508

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 study tests an investigational drug called linvoseltamab in 40 people with high-risk smoldering multiple myeloma, a condition that often leads to active multiple myeloma. The goal is to see if the drug can safely eliminate abnormal plasma cells and prevent the disease from progressing. The study has two parts: first checking safety in a small group, then expanding to more participants to measure effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
linvoseltamab (a drug given by injection or infusion)
What this could lead to
If it works, this could point toward a way to delay or prevent smoldering myeloma from turning into active multiple myeloma, potentially avoiding the need for more intensive treatments.
What could go wrong
This is an early Phase 2 study with only 40 people, so results may not apply to everyone. The drug can cause serious side effects like cytokine release syndrome and nerve problems, and it may not stop progression in all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

40 people

The number who actually took part.

Started

Jan 2024

Expected to finish

Jan 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Smoldering multiple myeloma (SMM) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Smoldering Multiple Myeloma smoldering plasma cell myeloma plasma cell myeloma prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Smoldering multiple myeloma (SMM)

Contacts and locations

Locations

  • Clinica Universidad de Navarra - Madrid

    Madrid, 28027, Spain

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, Navarre, 31008, Spain

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario Santiago de Compostela

    Santiago de Compostela, A Coruna, 15706, Spain

  • Hospital Clinico Universitario Virgen De La Arrixaca

    El Palmar, Murcia, 30120, Spain

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital General Universitario Gregorio Maranon (HGUGM) - Instituto de Investigacion Sanitaria Gregorio Maranon

    Madrid, 28009, Spain

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitari Son Llatzer

    Palma Mallorca, Balearic Islands, 07198, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Quiron Salud Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen de las Nieves

    Granada, Andalusia, 18014, Spain

  • Institut Catala d'Oncologia

    Barcelona, 08908, Spain

  • La Fe University Hospital

    Valencia, 46026, Spain

  • University Hospital Doctor Peset

    Valencia, 46017, Spain

  • University Hospital of Cabuenes

    Gijón, Principality of Asturias, 33203, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.