RecruitingPhase 2NCT06189833

Phase 2 Study Applying MRD Techniques for Participants With Previously Untreated Multiple Myeloma Treated With D-VRd Prior To and After High-dose Therapy Followed by ASCT - TAURUS

Phase 2 Study Applying Innovative Minimal Residual Disease (MRD) Techniques for Participants With Previously Untreated Multiple Myeloma Treated With D-VRd Prior To and After High-dose Therapy Followed by Autologous Stem Cell Transplantation (ASCT) - TAURUS


Sponsor

Stichting European Myeloma Network

Enrollment

200 participants

Start Date

Nov 23, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, single arm, open-label, Phase 2 study in mutiple myeloma with newly diagnosed and treatment-naïve participants for whom high-dose therapy and autologous stem cell transplantation is part of the intended treatment plan. The study is evaluating a technique called Mass Spectrometry Minimal Residual Disease (MS-MRD) using blood samples and compares it with the minimal residual disease (MRD) technique using bone marrow samples.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study (called TAURUS) tracks how well newly diagnosed multiple myeloma patients respond to D-VRd (a combination of daratumumab, bortezomib, lenalidomide, and dexamethasone) before and after a stem cell transplant, using highly sensitive tests to measure minimal residual disease (MRD — tiny amounts of remaining cancer cells). **You may be eligible if...** - You are between 18 and 70 years old - You have been newly diagnosed with multiple myeloma and have not yet been treated - Your treatment plan includes high-dose chemotherapy followed by an autologous stem cell transplant (using your own stem cells) - You are in adequate overall health (ECOG performance status 0, 1, or 2) **You may NOT be eligible if...** - You have previously received any treatment for multiple myeloma - A stem cell transplant is not part of your planned treatment - You have significant organ problems (heart, liver, or kidney) - You are pregnant or breastfeeding 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

DRUGDaratumumab

Daratumumab will be administered via a subcutaneous injection (SC)

DRUGBortezomib

Bortezomib will be administered via a subcutaneous injection (SC)

DRUGLenalidomide

Lenalidomide will be administered orally

DRUGDexamethasone

Dexamethasone will be administered orally


Locations(31)

Innsbruck Medical University

Innsbruck, Austria

Ordensklinikum Linz

Linz, Austria

Clinic Ottakring

Vienna, Austria

Medical University of Vienna

Vienna, Austria

Universitätsklinikum Hamburg - Eppendorf

Hamburg, Germany

Klinikum rechts der Isar (MRI) der Technischen Universität München Department of Internal Medicine III (Hematology/Oncology) Munchen

München, Germany

University Hospital of Alexandroupolis

Alexandroupoli, Greece

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

Athens, Greece

St Savvas Cancer Hospital

Athens, Greece

Theagenion Cancer Hospital

Thessaloniki, Greece

AOU Ospedali Riuniti di Ancona

Ancona, Italy

ASST Papa Giovanni XXIII Hospital

Bergamo, Italy

A.O.U. di Bologna - Policlinico S. Orsola Malpighi

Bologna, Italy

A.O.Spedali Civili di Brescia

Brescia, Italy

A.O.U. Careggi - Firenze

Florence, Italy

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

Genova, Italy

Novara Hospital

Novara, Italy

Policlinico S. Matteo Fondazione IRCCS - Pavia

Pavia, Italy

AUSL-IRCCS di Reggio Emilia Arcispedale S. Maria Nuova

Reggio Emilia, Italy

Ospedale "Infermi" di Rimini

Rimini, Italy

Ematologia IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo

San Giovanni Rotondo, Italy

A.O. S. Santa Maria Hospital Institute of Oncohematology Terni

Terni, Italy

A.O.U. Città della Salute e della Scienza di Torino - SC Ematologia U

Torino, Italy

Ospedale S. Maria della Misericordia di Udine

Udine, Italy

Amsterdam Medical Center

Amsterdam, Netherlands

Rijnstate

Arnhem, Netherlands

Amphia ziekenhuis

Breda, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Dijklander ziekenhuis

Purmerend, Netherlands

Erasmus University Medical Center Rotterdam

Rotterdam, Netherlands

Maasstad Ziekenhuis

Rotterdam, Netherlands

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NCT06189833


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