Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT06189833
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2023-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C556306', 'term': 'daratumumab'}, {'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-20', 'studyFirstSubmitDate': '2023-11-27', 'studyFirstSubmitQcDate': '2023-12-18', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '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.'}], 'secondaryOutcomes': [{'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', 'description': '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.'}, {'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', 'description': '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.'}, {'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', 'description': '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.'}, {'measure': 'MRD negativity rate BM-MRD and PB-MRD', 'timeFrame': 'Up to 12 months', 'description': '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'}, {'measure': 'ORR, VGPR or better, CR or better, sCR at post-induction, post-transplant, post-consolidation and overall.', 'timeFrame': 'Up to 12 months', 'description': '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.'}, {'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', 'description': '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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MS-MRD'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 70 years of age, inclusive.\n* Must have a new diagnosis of MM as per IMWG criteria.\n* Measurable disease\n* Newly diagnosed and treatment-naïve participants for whom high-dose therapy and autologous stem cell transplantation is part of the intended treatment plan.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\n* Clinical laboratory values meeting the required criteria during screening and ≤3 days prior to receiving first study treatment dose.\n* Adequate bone marrow function.\n* Adequate liver function.\n* Adequate renal function.\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* 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.\n* History of allogenic stem cell transplantation or prior organ transplant requiring immunosuppressive therapy.\n* 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.\n* 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.\n* Plasmapheresis ≤28 days of approval.\n* Radiation therapy for treatment of plasmacytoma ≤14 days of approval of enrollment.\n* Forced Expiratory Volume in 1 second (FEV1) \\<50% of predicted normal.\n* Concurrent medical or psychiatric condition or disease.\n* Myocardial infarction ≤6 months of enrollment, or an unstable or uncontrolled disease/condition related to or affecting cardiac function.\n* Uncontrolled cardiac arrhythmia or clinically significant electrocardiogram (ECG) abnormalities.\n* Allergy, hypersensitivity, or intolerance to boron or mannitol, corticosteroids, monoclonal antibodies or human proteins, or the excipients of daratumumab, lenalidomide, bortezomib or dexamethasone.\n* Pregnant or breast-feeding females'}, 'identificationModule': {'nctId': 'NCT06189833', 'acronym': 'TAURUS', 'briefTitle': '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', 'organization': {'class': 'NETWORK', 'fullName': 'European Myeloma Network B.V.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EMN33/54767414MMY2089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D-VRd + ASCT + DVRD', 'description': 'Participants will receive daratumumab, bortezomib, lenalidomide and dexamethasone (DVRD) for 4 induction cycles prior to and 2 consolidation cycles following autologous stem cell transplantation.\n\nDaratumumab 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', 'interventionNames': ['Drug: Daratumumab', 'Drug: Bortezomib', 'Drug: Lenalidomide', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Daratumumab', 'type': 'DRUG', 'otherNames': ['JNJ-54767414'], 'description': 'Daratumumab will be administered via a subcutaneous injection (SC)', 'armGroupLabels': ['D-VRd + ASCT + DVRD']}, {'name': 'Bortezomib', 'type': 'DRUG', 'otherNames': ['Velcade'], 'description': 'Bortezomib will be administered via a subcutaneous injection (SC)', 'armGroupLabels': ['D-VRd + ASCT + DVRD']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'description': 'Lenalidomide will be administered orally', 'armGroupLabels': ['D-VRd + ASCT + DVRD']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Dexamethasone will be administered orally', 'armGroupLabels': ['D-VRd + ASCT + DVRD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Innsbruck', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Willenbacher', 'role': 'CONTACT'}], 'facility': 'Innsbruck Medical University', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Linz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Strassl', 'role': 'CONTACT'}], 'facility': 'Ordensklinikum Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Vienna', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Schreder', 'role': 'CONTACT'}], 'facility': 'Clinic Ottakring', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Vienna', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Krauth', 'role': 'CONTACT'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Weisel', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Hamburg - Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'München', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Basserman', 'role': 'CONTACT'}], 'facility': 'Klinikum rechts der Isar (MRI) der Technischen Universität München Department of Internal Medicine III (Hematology/Oncology) Munchen', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Alexandroupoli', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Spanoudakis', 'role': 'CONTACT'}], 'facility': 'University Hospital of Alexandroupolis', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}, {'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Evangelos Terpos', 'role': 'CONTACT'}], 'facility': 'Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Pouli', 'role': 'CONTACT'}], 'facility': 'St Savvas Cancer Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Katodritou', 'role': 'CONTACT'}], 'facility': 'Theagenion Cancer Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Ancona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Offidani', 'role': 'CONTACT'}], 'facility': 'AOU Ospedali Riuniti di Ancona', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Bergamo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Rambaldi', 'role': 'CONTACT'}], 'facility': 'ASST Papa Giovanni XXIII Hospital', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Bologna', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Zamagni', 'role': 'CONTACT'}], 'facility': 'A.O.U. di Bologna - Policlinico S. Orsola Malpighi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Brescia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Belotti', 'role': 'CONTACT'}], 'facility': 'A.O.Spedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonioli', 'role': 'CONTACT'}], 'facility': 'A.O.U. Careggi - Firenze', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Genova', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Aquino', 'role': 'CONTACT'}, {'name': 'Aquino', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.U. Policlinico S. Martino - Ematologia', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Novara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Margiotta Casaluci', 'role': 'CONTACT'}], 'facility': 'Novara Hospital', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mangiacavalli', 'role': 'CONTACT'}], 'facility': 'Policlinico S. Matteo Fondazione IRCCS - Pavia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Reggio Emilia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gamberi', 'role': 'CONTACT'}], 'facility': 'AUSL-IRCCS di Reggio Emilia Arcispedale S. Maria Nuova', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'city': 'Rimini', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Tosi', 'role': 'CONTACT'}], 'facility': 'Ospedale "Infermi" di Rimini', 'geoPoint': {'lat': 44.05755, 'lon': 12.56528}}, {'city': 'San Giovanni Rotondo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Falcone', 'role': 'CONTACT'}], 'facility': 'Ematologia IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'city': 'Terni', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Liberati', 'role': 'CONTACT'}], 'facility': 'A.O. S. Santa Maria Hospital Institute of Oncohematology Terni', 'geoPoint': {'lat': 42.56335, 'lon': 12.64329}}, {'zip': '10126', 'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mina', 'role': 'CONTACT'}], 'facility': 'A.O.U. Città della Salute e della Scienza di Torino - SC Ematologia U', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Udine', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Patriarca', 'role': 'CONTACT'}], 'facility': 'Ospedale S. Maria della Misericordia di Udine', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'city': 'Amsterdam', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'van der Donk', 'role': 'CONTACT'}], 'facility': 'Amsterdam Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Arnhem', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Van der Spek', 'role': 'CONTACT'}], 'facility': 'Rijnstate', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'city': 'Breda', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'van der Klift', 'role': 'CONTACT'}, {'name': 'van der Klift', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Amphia ziekenhuis', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Groningen', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Roeloffzen', 'role': 'CONTACT'}], 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Purmerend', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Klerk', 'role': 'CONTACT'}], 'facility': 'Dijklander ziekenhuis', 'geoPoint': {'lat': 52.505, 'lon': 4.95972}}, {'city': 'Rotterdam', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Wester', 'role': 'CONTACT'}], 'facility': 'Erasmus University Medical Center Rotterdam', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Sprenger', 'role': 'CONTACT'}], 'facility': 'Maasstad Ziekenhuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Rosita Ghiraw-Visser', 'role': 'CONTACT', 'email': 'rosita.ghiraw@emn.org', 'phone': '+31 10 703 31 23'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stichting European Myeloma Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Janssen Pharmaceutica', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}