RecruitingPhase 2NCT06183489

Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma

A Multi-center, Open-label, Phase 2 Study of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma

Sponsor

Stichting European Myeloma Network

Enrollment

50 participants

Start Date

May 14, 2024

Study Type

INTERVENTIONAL

Conditions

Smoldering Multiple Myeloma

Summary

This is a multicenter, single arm, open-label, Phase 2 study in high risk smoldering myeloma patients. The primary objective is to determine the efficacy of Elranatamab in patients with previously untreated high-risk SMM. The key-secondary objective is to determine the safety of Elranatamab in patients with previously untreated high-risk SMM.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether elranatamab — a bispecific antibody that connects immune T cells directly to myeloma cells to kill them — can delay or prevent smoldering multiple myeloma (SMM) from progressing to active myeloma. Smoldering myeloma is an early, inactive stage where the cancer cells are present but not yet causing damage; patients with certain high-risk features are more likely to progress. **You may be eligible if...** - You are 18 or older with a diagnosis of smoldering multiple myeloma for 5 years or less - Your smoldering myeloma is classified as high-risk (based on specific lab markers like M protein level, bone marrow plasma cell percentage, or certain blood protein ratios) - You have not yet started treatment for active myeloma **You may NOT be eligible if...** - You have active (symptomatic) multiple myeloma requiring treatment - You have already received treatment for smoldering myeloma - You have organ damage linked to your myeloma (e.g., bone lesions, kidney problems, high calcium) - You have serious infections or organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGElranatamab

Elranatamab will be administered via a subcutaneous injection (SC)

Locations(25)

Helsinki University Hospital

Helsinki, Finland

CHD Vendée

La Roche-sur-Yon, France

CHRU de Lille - Hopital Claude Huriez

Lille, France

CHU Saint Eloi Département d'Hématologie Clinique

Montpellier, France

CHU Hôtel-Dieu, 1, place Alexis Ricordeau, 44093 NANTES Cedex 1, FRANCE

Nantes, France

CHU NICE - Hôpital Archet

Nice, France

CHU Poitiers - Pôle régional de Cancérologie

Poitiers, France

CHRU Hôpital Bretonneau

Tours, France

Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens

Athens, Greece

AOU Consorziale Policlinico di Bari

Bari, Italy

A.O. Papa Giovanni XXIII

Bergamo, Italy

A.O.U. Careggi

Florence, Italy

A.O.U. Policlinico S. Martino - Ematologia

Genova, Italy

Meldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

Meldola, Italy

Ospedale Papardo

Messina, Italy

A.O.U. Maggiore della Carità Novara

Novara, Italy

A.O. di Padova

Padova, Italy

A.O.U. di Parma - U.O Ematologia e CTMO

Parma, Italy

Fondazione IRCCS Policlinico S. Matteo

Pavia, Italy

Ospedale Santo Spirito Ospedale -Azienda Sanitaria Locale Di Pescara

Roma, Italy

Clinica Ematologica Azienda Sanitaria Universitaria Friuli Centrale

Udine, Italy

Maastricht UMC

Maastricht, Netherlands

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Erasmus MC

Rotterdam, Netherlands

Oslo Myeloma Center

Oslo, Norway

View Full Details on ClinicalTrials.gov

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NCT06183489

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