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

Last updated: April 20, 2024
Sponsor: Stichting European Myeloma Network
Overall Status: Active - Recruiting

Phase

2

Condition

Bone Neoplasm

Cancer/tumors

Cancer

Treatment

Dexamethasone

Bortezomib

Daratumumab

Clinical Study ID

NCT06189833
EMN33/54767414MMY2089
  • Ages 18-70
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 18 to 70 years of age, inclusive.
  • Must have a new diagnosis of MM as per IMWG criteria.
  • Measurable disease
  • Newly diagnosed and treatment-naïve participants for whom high-dose therapy andautologous stem cell transplantation is part of the intended treatment plan.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
  • Clinical laboratory values meeting the required criteria during screening and ≤3 daysprior to receiving first study treatment dose.
  • Adequate bone marrow function.
  • Adequate liver function.
  • Adequate renal function.
  • A female of childbearing potential (FOCBP) must have two negative serum or urinepregnancy tests at screening including within 24 hours of the start of studytreatment.
  • Willing to practicing at least 1 highly effective method of contraception starting 4weeks prior to start of study treatment, while receiving study treatment includingduring any dose interruptions, and for at least 3 months after the last dose of anycomponent of the study treatment.

Exclusion

Exclusion Criteria:

  • Prior or current systemic therapy or ASCT for any plasma cell dyscrasia, with theexception of emergency use of a short course (equivalent of dexamethasone 40 mg/dayfor a maximum 4 days) of corticosteroids before treatment.
  • History of allogenic stem cell transplantation or prior organ transplant requiringimmunosuppressive therapy.
  • Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by theNational Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)Version 5.
  • Myelodysplastic syndrome or any malignancy within 24 months of signing consent. Theonly exceptions are malignancies treated within the last 24 months that are consideredcompletely cured.
  • Plasmapheresis ≤28 days of approval.
  • Radiation therapy for treatment of plasmacytoma ≤14 days of approval of enrollment.
  • Forced Expiratory Volume in 1 second (FEV1) <50% of predicted normal.
  • Concurrent medical or psychiatric condition or disease.
  • Myocardial infarction ≤6 months of enrollment, or an unstable or uncontrolleddisease/condition related to or affecting cardiac function.
  • Uncontrolled cardiac arrhythmia or clinically significant electrocardiogram (ECG)abnormalities.
  • Allergy, hypersensitivity, or intolerance to boron or mannitol, corticosteroids,monoclonal antibodies or human proteins, or the excipients of daratumumab,lenalidomide, bortezomib or dexamethasone.
  • Pregnant or breast-feeding females

Study Design

Total Participants: 200
Treatment Group(s): 4
Primary Treatment: Dexamethasone
Phase: 2
Study Start date:
November 23, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Innsbruck Medical University

    Innsbruck,
    Austria

    Site Not Available

  • Ordensklinikum Linz

    Linz,
    Austria

    Active - Recruiting

  • Clinic Ottakring

    Vienna,
    Austria

    Site Not Available

  • Medical University of Vienna

    Vienna,
    Austria

    Site Not Available

  • Universitätsklinikum Hamburg - Eppendorf

    Hamburg,
    Germany

    Active - Recruiting

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

    München,
    Germany

    Site Not Available

  • University Hospital of Alexandroupolis

    Alexandroupolis,
    Greece

    Active - Recruiting

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

    Athens,
    Greece

    Active - Recruiting

  • St Savvas Cancer Hospital

    Athens,
    Greece

    Active - Recruiting

  • Theagenion Cancer Hospital

    Thessaloníki,
    Greece

    Active - Recruiting

  • AOU Ospedali Riuniti di Ancona

    Ancona,
    Italy

    Active - Recruiting

  • ASST Papa Giovanni XXIII Hospital

    Bergamo,
    Italy

    Active - Recruiting

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

    Bologna,
    Italy

    Site Not Available

  • A.O.Spedali Civili di Brescia

    Brescia,
    Italy

    Active - Recruiting

  • A.O.U. Careggi - Firenze

    Firenze,
    Italy

    Active - Recruiting

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

    Genova,
    Italy

    Site Not Available

  • Novara Hospital

    Novara,
    Italy

    Active - Recruiting

  • Policlinico S. Matteo Fondazione IRCCS - Pavia

    Pavia,
    Italy

    Active - Recruiting

  • AUSL-IRCCS di Reggio Emilia Arcispedale S. Maria Nuova

    Reggio Emilia,
    Italy

    Active - Recruiting

  • Ospedale "Infermi" di Rimini

    Rimini,
    Italy

    Active - Recruiting

  • Ematologia IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo

    San Giovanni Rotondo,
    Italy

    Active - Recruiting

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

    Terni,
    Italy

    Site Not Available

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

    Torino, 10126
    Italy

    Active - Recruiting

  • Ospedale S. Maria della Misericordia di Udine

    Udine,
    Italy

    Site Not Available

  • Amsterdam Medical Center

    Amsterdam,
    Netherlands

    Site Not Available

  • Rijnstate

    Arnhem,
    Netherlands

    Active - Recruiting

  • Amphia ziekenhuis

    Breda,
    Netherlands

    Site Not Available

  • University Medical Center Groningen

    Groningen,
    Netherlands

    Site Not Available

  • Dijklander ziekenhuis

    Purmerend,
    Netherlands

    Active - Recruiting

  • Erasmus University Medical Center Rotterdam

    Rotterdam,
    Netherlands

    Site Not Available

  • Maasstad Ziekenhuis

    Rotterdam,
    Netherlands

    Active - Recruiting

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