Clinical trial NCT06189833: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: MS-MRD
Lead sponsor: European Myeloma Network B.V.
Sponsor class: NETWORK
Collaborators: name: Janssen Pharmaceutica
First posted: 2024-01-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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 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:

* 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.
* 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

Primary outcomes:
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.
timeFrame: Up to 12 months
Secondary outcomes:
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-induction.
timeFrame: Up to 4 months and 2 weeks
measure: 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.
timeFrame: Up to 12 months
measure: Proportion (%) of agreement and disagreement in the MRD measurements in BM by NGF-MRD and NGS-MRD at post-induction and post-consolidation.
timeFrame: Up to 12 months
measure: MRD negativity rate BM-MRD and PB-MRD
timeFrame: Up to 12 months
measure: ORR, VGPR or better, CR or better, sCR at post-induction, post-transplant, post-consolidation and overall.
timeFrame: Up to 12 months
measure: 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.
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Innsbruck Medical University
city: Linz
country: Austria
facility: Ordensklinikum Linz
city: Vienna
country: Austria
facility: Clinic Ottakring
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg - Eppendorf
city: München
country: Germany
facility: Klinikum rechts der Isar (MRI) der Technischen Universität München Department of Internal Medicine III (Hematology/Oncology) Munchen
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
city: Athens
country: Greece
facility: Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens
city: Athens
country: Greece
facility: St Savvas Cancer Hospital
city: Thessaloníki
country: Greece
facility: Theagenion Cancer Hospital
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti di Ancona
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII Hospital
city: Bologna
country: Italy
facility: A.O.U. di Bologna - Policlinico S. Orsola Malpighi
city: Brescia
country: Italy
facility: A.O.Spedali Civili di Brescia
city: Firenze
country: Italy
facility: A.O.U. Careggi - Firenze
city: Genova
country: Italy
facility: A.O.U. Policlinico S. Martino - Ematologia
city: Novara
country: Italy
facility: Novara Hospital
city: Pavia
country: Italy
facility: Policlinico S. Matteo Fondazione IRCCS - Pavia
city: Reggio Emilia
country: Italy
facility: AUSL-IRCCS di Reggio Emilia Arcispedale S. Maria Nuova
city: Rimini
country: Italy
facility: Ospedale "Infermi" di Rimini
city: San Giovanni Rotondo
country: Italy
facility: Ematologia IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo
city: Terni
country: Italy
facility: A.O. S. Santa Maria Hospital Institute of Oncohematology Terni
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino - SC Ematologia U
city: Udine
country: Italy
facility: Ospedale S. Maria della Misericordia di Udine
city: Amsterdam
country: Netherlands
facility: Amsterdam Medical Center
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Breda
country: Netherlands
facility: Amphia ziekenhuis
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Purmerend
country: Netherlands
facility: Dijklander ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center Rotterdam
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
Study officials:
References: