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Multiple MyelomaPhase 2TAURUSNCT06189833

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

A Phase 2 study testing Daratumumab, Bortezomib and Lenalidomide in people with Multiple Myeloma, run by Stichting European Myeloma Network at 31 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Daratumumab, Bortezomib and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
31 sitesin 5 countries
Study dates
23 Nov 2023to Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 and autologous 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 days prior to receiving first study treatment dose.
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  • Adequate bone marrow function.
  • Adequate liver function.
  • Adequate renal function.
  • A female of childbearing potential (FOCBP) must have two negative serum or urine pregnancy tests at screening including within 24 hours of the start of study treatment.
  • Willing to practicing at least 1 highly effective method of contraception starting 4 weeks prior to start of study treatment, while receiving study treatment including during any dose interruptions, and for at least 3 months after the last dose of any component of the study treatment.

Who cannot join

  • Prior or current systemic therapy or ASCT for any plasma cell dyscrasia, with the exception of emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment.
  • History of allogenic stem cell transplantation or prior organ transplant requiring immunosuppressive therapy.
  • Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.
  • Myelodysplastic syndrome or any malignancy within 24 months of signing consent. The only exceptions are malignancies treated within the last 24 months that are considered completely cured.
  • Plasmapheresis ≤28 days of approval.
  • Radiation therapy for treatment of plasmacytoma ≤14 days of approval of enrollment.
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  • 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 uncontrolled disease/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

Trial locations and contacts

31 sites in 5 countries.

Rosita Ghiraw-Visser contact

+31 10 703 31 23

rosita.ghiraw@emn.org

31 sites in 5 countries

Italy14 sites, 14 recruiting

  • AOU Ospedali Riuniti di Ancona

    Ancona

    Offidani

    Recruiting

  • ASST Papa Giovanni XXIII Hospital

    Bergamo

    Rambaldi

    Recruiting

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

    Bologna

    Zamagni

    Not yet recruiting

  • A.O.Spedali Civili di Brescia

    Brescia

    Belotti

    Recruiting

  • A.O.U. Careggi - Firenze

    Florence

    Antonioli

    Recruiting

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

    Genova

    Aquino

    Aquino

    Not yet recruiting

  • Novara Hospital

    Novara

    Margiotta Casaluci

    Recruiting

  • Policlinico S. Matteo Fondazione IRCCS - Pavia

    Pavia

    Mangiacavalli

    Recruiting

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

    Reggio Emilia

    Gamberi

    Recruiting

  • Ospedale "Infermi" di Rimini

    Rimini

    Tosi

    Recruiting

  • Ematologia IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo

    San Giovanni Rotondo

    Falcone

    Recruiting

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

    Terni

    Liberati

    Not yet recruiting

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

    Torino, 10126

    Mina

    Recruiting

  • Ospedale S. Maria della Misericordia di Udine

    Udine

    Patriarca

    Not yet recruiting

Other trials in Italy

Netherlands7 sites, 7 recruiting

  • Amsterdam Medical Center

    Amsterdam

    van der Donk

    Not yet recruiting

  • Rijnstate

    Arnhem

    Van der Spek

    Recruiting

  • Amphia ziekenhuis

    Breda

    van der Klift

    van der Klift

    Not yet recruiting

  • University Medical Center Groningen

    Groningen

    Roeloffzen

    Not yet recruiting

  • Dijklander ziekenhuis

    Purmerend

    Klerk

    Recruiting

  • Erasmus University Medical Center Rotterdam

    Rotterdam

    Wester

    Not yet recruiting

  • Maasstad Ziekenhuis

    Rotterdam

    Sprenger

    Recruiting

Other trials in Netherlands

Austria4 sites, 4 recruiting

  • Innsbruck Medical University

    Innsbruck

    Willenbacher

    Not yet recruiting

  • Ordensklinikum Linz

    Linz

    Strassl

    Recruiting

  • Clinic Ottakring

    Vienna

    Schreder

    Not yet recruiting

  • Medical University of Vienna

    Vienna

    Krauth

    Not yet recruiting

Other trials in Austria

Greece4 sites, 4 recruiting

  • University Hospital of Alexandroupolis

    Alexandroupoli

    Spanoudakis

    Recruiting

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

    Athens

    Evangelos Terpos

    Recruiting

  • St Savvas Cancer Hospital

    Athens

    Pouli

    Recruiting

  • Theagenion Cancer Hospital

    Thessaloniki

    Katodritou

    Recruiting

Other trials in Greece

Germany2 sites, 2 recruiting

  • Universitätsklinikum Hamburg - Eppendorf

    Hamburg

    Weisel

    Recruiting

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

    München

    Basserman

    Not yet recruiting

Other trials in Germany

About this study

Official title: 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

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.

Keywords
MS-MRD
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaratumumabDrug

    Also called JNJ-54767414

    Daratumumab will be administered via a subcutaneous injection (SC)

  • BortezomibDrug

    Also called Velcade

    Bortezomib will be administered via a subcutaneous injection (SC)

  • LenalidomideDrug

    Lenalidomide will be administered orally

  • DexamethasoneDrug

    Dexamethasone will be administered orally

Study groups in NCT06189833
Study groupRoleWhat they receive
D-VRd + ASCT + DVRDExperimentalParticipants will receive daratumumab, bortezomib, lenalidomide and dexamethasone (DVRD) for 4 induction cycles prior to and 2 consolidation cycles following autologous stem cell transplantation. Daratumumab subcutaneously (SC), 1800 mg on days 1, 8, 15 and 22 of cycle 1 and 2, on days 1 and 15 of cycle 3-6 Bortezomib SC 1.3mg/m2 on days 1, 8, 15, 22 of cycle 1-6 Lenalidomide orally 25 mg once daily on days 1-21 of cycle 1-6 Dexamethasone 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22 and 23 of cycle 1-6
Receives: Drug: Daratumumab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion (%) of agreement and disagreement in the MRD measurements in BM (by NGS-MRD) and in the MRD measurements in peripheral blood (by MS-MRD) at post-consolidation.

    The proportion (%) of agreement will be defined as the total number of concordant cases (i.e., MRD-positive by both techniques, MRD-negative by both techniques) versus the total number of cases with available results.

    Measured: Up to 12 months

Secondary outcomes (6)

  1. Proportion (%) of agreement and disagreement in the MRD measurements in BM (by NGS-MRD) and in the MRD measurements in peripheral blood (by MS-MRD) at post-induction.

    The proportion (%) of agreement will be defined as the total number of concordant cases (i.e., MRD-positive by both techniques, MRD-negative by both techniques) versus the total number of cases with available results.

    Measured: Up to 4 months and 2 weeks

  2. Proportion (%) of agreement and disagreement in the MRD measurements in BM (by NGF-MRD) and in the MRD measurements in peripheral blood (by MS-MRD) at post-induction and post-consolidation.

    The proportion (%) of agreement will be defined as the total number of concordant cases (i.e., MRD-positive by both techniques, MRD-negative by both techniques) versus the total number of cases with available results.

    Measured: Up to 12 months

  3. Proportion (%) of agreement and disagreement in the MRD measurements in BM by NGF-MRD and NGS-MRD at post-induction and post-consolidation.

    The proportion (%) of agreement will be defined as the total number of concordant cases (i.e., MRD-positive by both techniques, MRD-negative by both techniques) versus the total number of cases with available results.

    Measured: Up to 12 months

  4. MRD negativity rate BM-MRD and PB-MRD

    To evaluate the MRD negativity rate achieved at any time up to the end of consolidation with BM based MRD techniques and with the MS-MRD technique

    Measured: Up to 12 months

  5. ORR, VGPR or better, CR or better, sCR at post-induction, post-transplant, post-consolidation and overall.

    ORR will be defined as the percentage of participants achieving confirmed PR or better (i.e., PR+VGPR+CR+sCR). The number and percentage of participants achieving ORR, VGPR or better, CR or better and sCR will be presented, post-induction, post-consolidation, post-transplant and overall.

    Measured: Up to 12 months

  6. Effect of cytogenetic abnormalities (presence or not), R-ISS (1, 2 or 3), CTCs (number of cells per ml) on likelihood to develop MRD-negative disease (with MS, NGS and NGF) and the agreement between the different techniques.

    Binary logistic regression will be used to identify factors associated with post-induction and post-consolidation MRD status (negative or positive) (as defined with NGS-MRD; NGF-MRD; MS-MRD; the most conservative method), in the MRD-evaluable Analysis Set. Odds ratios and respective 95% CIs will be estimated from univariable and multivariable models.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start23 Nov 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06189833
Sponsor's protocol ID
EMN33/54767414MMY2089
Acronym
TAURUS
Status last verified
Apr 2024
First submitted
27 Nov 2023
Last updated
23 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daratumumab, Bortezomib and Lenalidomide in people with Multiple Myeloma, run by Stichting European Myeloma Network at 31 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Italy, Netherlands, Austria, Greece, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rosita Ghiraw-Visser (+31 10 703 31 23, rosita.ghiraw@emn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion (%) of agreement and disagreement in the MRD measurements in BM (by NGS-MRD) and in the MRD measurements in peripheral blood (by MS-MRD) at post-consolidation. (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06189833.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024; AzTrials last refreshed its copy on 29 Oct 2026.

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