Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-26 @ 10:10 AM
Study NCT ID:
NCT07045168
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk-adapted Therapeutic Strategy in +1q NDMM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D018365', 'term': 'Neoplasm, Residual'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood、bone marrow'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-07-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-07', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-06-26', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRD negativity rate', 'timeFrame': 'through study completion, up to 2 years', 'description': 'To compare MRD negativity rate between low/intermediate- and high-risk +1q NDMM patients undergoing risk-adapted individualized treatment.'}, {'measure': 'sustained MRD negativity rate', 'timeFrame': 'through study completion, up to 2 years', 'description': 'To compare sustained MRD negativity rate between low/intermediate- and high-risk +1q NDMM patients undergoing risk-adapted individualized treatment.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'through study completion, up to 2 years', 'description': 'PFS were calculated from the enrollment to the first instance of disease progression, relapse, or death'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'through study completion, up to 2 years', 'description': 'OS were calculated from the time of enrollment to death or the last follow-up'}, {'measure': 'objective response rate', 'timeFrame': 'through study completion, up to 2 years', 'description': 'To assess the objective response rate (ORR) and depth of response based on 2016 IMWG criteria (sCR, CR, VGPR, PR).'}, {'measure': 'Treatment related adverse event(TRAE)', 'timeFrame': 'through study completion, up to 2 years', 'description': 'Toxicity and safety will be reported based on the adverse events, as graded by CTCAE V5 and determined by routine clinical assessments.'}], 'secondaryOutcomes': [{'measure': 'differences between MRD-negative and MRD-positive patients', 'timeFrame': 'through study completion, up to 2 years', 'description': 'Number of participants with distinct immunological (T-cell subsets by flow cytometry), inflammatory (CRP, IL-6 levels), genomic (mutational burden by NGS), and proteomic (LC-MS/MS) signatures in MRD-negative vs. MRD-positive patients.'}, {'measure': 'elderly +1q NDMM patients', 'timeFrame': 'through study completion, up to 2 years', 'description': 'Number of participants achieving MRD negativity (by next-generation sequencing \\[NGS\\] at 10\\^-5 sensitivity) and progression-free survival (PFS) at 24 months in elderly intermediate/high-risk +1q NDMM patients receiving MRD-tailored therapy.'}, {'measure': 'The efficacy of 1q negativity patients', 'timeFrame': 'through study completion, up to 2 years', 'description': 'Patients with 1q negativity were included as the control group. According to the 2025 IMWG Risk Stratification, patients were divided into the high-risk group and the low-risk group. It is recommended that patients in the high-risk group receive CD38 monoclonal antibody in combination with the KRD regimen, while patients in the low-risk group receive CD38 monoclonal antibody in combination with the VRD regimen. The efficacy of these patients were compared with those of patients stratified by 1q risk through objective response rate (ORR) and depth of response based on 2016 IMWG criteria (sCR, CR, VGPR, PR) .'}, {'measure': 'The survival of 1q negativity patients', 'timeFrame': 'through study completion, up to 2 years', 'description': 'Patients with 1q negativity were included as the control group. According to the 2025 IMWG Risk Stratification, patients were divided into the high-risk group and the low-risk group. It is recommended that patients in the high-risk group receive CD38 monoclonal antibody in combination with the KRD regimen, while patients in the low-risk group receive CD38 monoclonal antibody in combination with the VRD regimen. The survival of these patients were compared with those of patients stratified by 1q risk through PFS and OS'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Risk-adapted therapeutic strategy', '+1q MM', 'high-risk MM', 'minimal residual disease'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '33516340', 'type': 'BACKGROUND', 'citation': 'van de Donk NWCJ, Pawlyn C, Yong KL. Multiple myeloma. Lancet. 2021 Jan 30;397(10272):410-427. doi: 10.1016/S0140-6736(21)00135-5.'}, {'pmid': '34727187', 'type': 'BACKGROUND', 'citation': 'Zamagni E, Barbato S, Cavo M. How I treat high-risk multiple myeloma. Blood. 2022 May 12;139(19):2889-2903. doi: 10.1182/blood.2020008733.'}, {'pmid': '29686421', 'type': 'BACKGROUND', 'citation': 'Kumar SK, Rajkumar SV. The multiple myelomas - current concepts in cytogenetic classification and therapy. Nat Rev Clin Oncol. 2018 Jul;15(7):409-421. doi: 10.1038/s41571-018-0018-y.'}, {'pmid': '27002115', 'type': 'BACKGROUND', 'citation': 'Sonneveld P, Avet-Loiseau H, Lonial S, Usmani S, Siegel D, Anderson KC, Chng WJ, Moreau P, Attal M, Kyle RA, Caers J, Hillengass J, San Miguel J, van de Donk NW, Einsele H, Blade J, Durie BG, Goldschmidt H, Mateos MV, Palumbo A, Orlowski R. Treatment of multiple myeloma with high-risk cytogenetics: a consensus of the International Myeloma Working Group. Blood. 2016 Jun 16;127(24):2955-62. doi: 10.1182/blood-2016-01-631200. Epub 2016 Mar 21.'}, {'pmid': '33262523', 'type': 'BACKGROUND', 'citation': 'Croft J, Ellis S, Sherborne AL, Sharp K, Price A, Jenner MW, Drayson MT, Owen RG, Chown S, Lindsay J, Karunanithi K, Hunter H, Gregory WM, Davies FE, Morgan GJ, Cook G, Atanesyan L, Savola S, Cairns DA, Jackson G, Houlston RS, Kaiser MF. Copy number evolution and its relationship with patient outcome-an analysis of 178 matched presentation-relapse tumor pairs from the Myeloma XI trial. Leukemia. 2021 Jul;35(7):2043-2053. doi: 10.1038/s41375-020-01096-y. Epub 2020 Dec 1.'}, {'pmid': '30704229', 'type': 'BACKGROUND', 'citation': 'Wu J, Lu AD, Zhang LP, Zuo YX, Jia YP. [Study of clinical outcome and prognosis in pediatric core binding factor-acute myeloid leukemia]. Zhonghua Xue Ye Xue Za Zhi. 2019 Jan 14;40(1):52-57. doi: 10.3760/cma.j.issn.0253-2727.2019.01.010. Chinese.'}, {'pmid': '35605179', 'type': 'BACKGROUND', 'citation': "D'Agostino M, Cairns DA, Lahuerta JJ, Wester R, Bertsch U, Waage A, Zamagni E, Mateos MV, Dall'Olio D, van de Donk NWCJ, Jackson G, Rocchi S, Salwender H, Blade Creixenti J, van der Holt B, Castellani G, Bonello F, Capra A, Mai EK, Durig J, Gay F, Zweegman S, Cavo M, Kaiser MF, Goldschmidt H, Hernandez Rivas JM, Larocca A, Cook G, San-Miguel JF, Boccadoro M, Sonneveld P. Second Revision of the International Staging System (R2-ISS) for Overall Survival in Multiple Myeloma: A European Myeloma Network (EMN) Report Within the HARMONY Project. J Clin Oncol. 2022 Oct 10;40(29):3406-3418. doi: 10.1200/JCO.21.02614. Epub 2022 May 23."}, {'pmid': '35102148', 'type': 'BACKGROUND', 'citation': 'Abdallah NH, Binder M, Rajkumar SV, Greipp PT, Kapoor P, Dispenzieri A, Gertz MA, Baughn LB, Lacy MQ, Hayman SR, Buadi FK, Dingli D, Go RS, Hwa YL, Fonder AL, Hobbs MA, Lin Y, Leung N, Kourelis T, Warsame R, Siddiqui MA, Kyle RA, Bergsagel PL, Fonseca R, Ketterling RP, Kumar SK. A simple additive staging system for newly diagnosed multiple myeloma. Blood Cancer J. 2022 Jan 31;12(1):21. doi: 10.1038/s41408-022-00611-x.'}, {'pmid': '29967379', 'type': 'BACKGROUND', 'citation': 'Walker BA, Mavrommatis K, Wardell CP, Ashby TC, Bauer M, Davies F, Rosenthal A, Wang H, Qu P, Hoering A, Samur M, Towfic F, Ortiz M, Flynt E, Yu Z, Yang Z, Rozelle D, Obenauer J, Trotter M, Auclair D, Keats J, Bolli N, Fulciniti M, Szalat R, Moreau P, Durie B, Stewart AK, Goldschmidt H, Raab MS, Einsele H, Sonneveld P, San Miguel J, Lonial S, Jackson GH, Anderson KC, Avet-Loiseau H, Munshi N, Thakurta A, Morgan G. A high-risk, Double-Hit, group of newly diagnosed myeloma identified by genomic analysis. Leukemia. 2019 Jan;33(1):159-170. doi: 10.1038/s41375-018-0196-8. Epub 2018 Jul 2.'}, {'pmid': '36309982', 'type': 'BACKGROUND', 'citation': 'Yang P, Chen H, Liang X, Xu W, Yu S, Huang W, Yi X, Guo Q, Tian M, Yue T, Li M, Zhang Y, Zhang M, Yan Y, Hu Z, Kumar SK, Zhou F, Dai Y, Jin F. Proposed risk-scoring model for estimating the prognostic impact of 1q gain in patients with newly diagnosed multiple myeloma. Am J Hematol. 2023 Feb;98(2):251-263. doi: 10.1002/ajh.26774. Epub 2022 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'This real-world, multicenter prospective clinical study is designed to apply our internationally developed prognostic scoring system to guide individualized therapy in +1q newly diagnosed multiple myeloma (NDMM), using minimal residual disease (MRD) status as the primary endpoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed NDMM by 2014 IMWG criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>=18, or \\>=65 and fit according to IMWG-FI.\n* Newly diagnosed NDMM by 2014 IMWG criteria.\n* Adequate organ function for systemic therapy.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Active infections requiring systemic treatment.\n* Unstable angina, NYHA class III-IV heart failure, or uncontrolled arrhythmias.\n* History of hematologic or solid tumors treated with chemo/radiotherapy within 5 years.\n* Current malignancies requiring therapy.\n* Refusal to participate.'}, 'identificationModule': {'nctId': 'NCT07045168', 'briefTitle': 'Risk-adapted Therapeutic Strategy in +1q NDMM', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'Risk-adapted Therapeutic Strategy in +1q NDMM： a Prospective, Multicenter Study', 'orgStudyIdInfo': {'id': 'Risk-adapted therapy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'low-risk +1q NDMM patients', 'description': 'This system classifies +1q NDMM patients into low, intermediate, and high-risk groups based on coexisting International Staging System (ISS) stage III, hypercalcemia, high lactate dehydrogenase (LDH), and t(14;16).Patients with ISS stage III, elevated LDH, hypercalcemia, and t(14;16) were assigned scores of 1 point, 1 point, 2 points, and 3 points, respectively. According to the tertiles of their scores,the patients with +1q were classified into low- (0 point) .', 'interventionNames': ['Other: risk-scoring model']}, {'label': 'intermediate/high-risk +1q NDMM patients', 'description': 'This system classifies +1q NDMM patients into low, intermediate, and high-risk groups based on coexisting ISS stage III, hypercalcemia, high LDH, and t(14;16).Patients with ISS stage III, elevated LDH, hypercalcemia, and t(14;16) were assigned scores of 1 point, 1 point, 2 points, and 3 points, respectively. According to the tertiles of their scores,the patients with +1q was classified into intermediate- (1-3 points) and high-risk (4-7 points) groups.', 'interventionNames': ['Other: risk-scoring model']}, {'label': '1q negativity low-risk group', 'description': 'Patients with 1q negativity were included as the control group, and patients were stratified into the high-risk group and low-risk group according to the 2025 IMWG Risk Stratification.'}, {'label': '1q negativity high-risk group', 'description': 'Patients with 1q negativity were included as the control group, and patients were stratified into the high-risk group and low-risk group according to the 2025 IMWG Risk Stratification.'}], 'interventions': [{'name': 'risk-scoring model', 'type': 'OTHER', 'otherNames': ['Proposed risk-scoring model for estimating the prognostic impact of 1q gain in patients with newly diagnosed multiple myeloma'], 'description': 'This system classifies +1q NDMM patients into low, intermediate, and high-risk groups based on coexisting ISS stage III, hypercalcemia, high LDH, and t(14;16).Patients with ISS stage III, elevated LDH, hypercalcemia, and t(14;16) were assigned scores of 1 point, 1 point, 2 points, and 3 points, respectively. According to the tertiles of their scores,the patients with +1q were classified into low- (0 point),intermediate- (1-3 points), and high-risk (4-7 points) groups.', 'armGroupLabels': ['intermediate/high-risk +1q NDMM patients', 'low-risk +1q NDMM patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FengYan Jin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'The First Hospital of Jilin University', 'investigatorFullName': 'FengYan Jin', 'investigatorAffiliation': 'The First Hospital of Jilin University'}}}}