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
NCT ID: NCT06189833
Last Updated: 2024-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2023-11-23
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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D-VRd + ASCT + DVRD
Participants 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
Daratumumab
Daratumumab will be administered via a subcutaneous injection (SC)
Bortezomib
Bortezomib will be administered via a subcutaneous injection (SC)
Lenalidomide
Lenalidomide will be administered orally
Dexamethasone
Dexamethasone will be administered orally
Interventions
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Daratumumab
Daratumumab will be administered via a subcutaneous injection (SC)
Bortezomib
Bortezomib will be administered via a subcutaneous injection (SC)
Lenalidomide
Lenalidomide will be administered orally
Dexamethasone
Dexamethasone will be administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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
18 Years
70 Years
ALL
No
Sponsors
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Janssen Pharmaceutica
INDUSTRY
Stichting European Myeloma Network
NETWORK
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Willenbacher
Role: primary
Strassl
Role: primary
Schreder
Role: primary
Krauth
Role: primary
Weisel
Role: primary
Basserman
Role: primary
Spanoudakis
Role: primary
Evangelos Terpos
Role: primary
Pouli
Role: primary
Katodritou
Role: primary
Offidani
Role: primary
Rambaldi
Role: primary
Zamagni
Role: primary
Belotti
Role: primary
Antonioli
Role: primary
Aquino
Role: primary
Margiotta Casaluci
Role: primary
Mangiacavalli
Role: primary
Gamberi
Role: primary
Tosi
Role: primary
Falcone
Role: primary
Liberati
Role: primary
Mina
Role: primary
Patriarca
Role: primary
van der Donk
Role: primary
Van der Spek
Role: primary
van der Klift
Role: primary
Roeloffzen
Role: primary
Klerk
Role: primary
Wester
Role: primary
Sprenger
Role: primary
Other Identifiers
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EMN33/54767414MMY2089
Identifier Type: -
Identifier Source: org_study_id
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