Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:34 AM
Study NCT ID:
NCT07391657
Status:
RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'C524865', 'term': 'carfilzomib'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'C467566', 'term': 'pomalidomide'}], 'ancestors': [{'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'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open-label'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 508}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2030-07-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-01-30', 'studyFirstSubmitQcDate': '2026-01-30', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of PFS in participants with RRMM.', 'timeFrame': '3 years', 'description': 'PFS: defined as time from randomisation until progression according to IMWG 2016 criteria as assessed by BICR, or death due to any cause, whichever occurs first.'}, {'measure': 'To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of MRD negativity rate at 9 months in participants with RRMM.', 'timeFrame': '2 years', 'description': 'MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status and have a response of CR or sCR (according to the IMWG 2016 criteria) at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.'}], 'secondaryOutcomes': [{'measure': 'To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of CRR in participants with RRMM.', 'timeFrame': '2 years'}, {'measure': 'To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of ORR in participants with RRMM.', 'timeFrame': '2 years'}, {'measure': 'To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of OS in participants with RRMM.', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BCMA', 'CAR-T', 'CD19'], 'conditions': ['Relapsed Refractory Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (DKd \\[daratumumab, carfilzomib, and dexamethasone\\], DPd \\[daratumumab, pomalidomide, and dexamethasone\\], PVd \\[pomalidomide, bortezomib and dexamethasone\\], or Kd \\[carfilzomib and dexamethasone\\]) in participants with RRMM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria\n* Documented evidence of measurable disease:\n\n 1. Serum M-protein level ≥ 1 g/dL\n 2. Urine M-protein level ≥ 200 mg/24h\n 3. Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio\n* Documented evidence of PD by IMWG 2016 criteria based on investigator's determination during or after the most recent line of therapy. Participants with only 1 prior line of therapy must have progressed within 47 months of a stem cell transplant, or if not transplanted, then within 42 months of starting initial therapy\n* Received 1 to 3 lines of prior therapy including an IMiD and either a PI or a CD38 antibody. Participant must have undergone at least 2 complete cycles of treatment for each line of therapy, unless PD was the best response to the line of therapy\n* Eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) as determined by the Investigator.\n* ECOG performance status score of 0 to 1\n* Adequate hematology and chemistry laboratory values:\n\n 1. Haemoglobin ≥ 8.0 g/dL\n 2. Absolute neutrophil count ≥ 1 × 10\\^9/L (1000 per mm3)\n 3. Platelet count ≥ 75 × 10\\^9/L (75000 per mm3) in participants with \\< 50% of bone marrow nucleated cells are plasma cells or ≥ 50 × 10\\^9/L (50000 per mm3) in participants with ≥ 50% of bone marrow nucleated cells are plasma cells\n 4. Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L)\n 5. Total bilirubin ≤ 1.5 × ULN in the absence of Gilbert's syndrome or ≤ 3 × ULN if the participant has Gilbert's syndrome. AST and ALT≤ 3.0 × ULN. CrCl by Cockcroft and Gault method ≥ 30 mL/minute\n\nExclusion Criteria:\n\n* Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.\n* Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome.\n* Participants with primary refractory MM (failed to generate at least a minimal response to any prior therapy)\n* Significant neurological or psychiatric condition\n* Significant medical condition that places the participant at an unacceptable risk for treatment-related complications\n* Previously received any prior BCMA-targeted treatment\n* Previously received CAR-T or CAR-NK therapy directed at any target\n* Previously received T-cell engager therapy directed at any target\n* Previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of randomization"}, 'identificationModule': {'nctId': 'NCT07391657', 'acronym': 'DURGA-4', 'briefTitle': 'A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase III Open-label, Randomised, Multicentre Study Comparing AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CART) Therapy Directed Against BCMA and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma.', 'orgStudyIdInfo': {'id': 'D8311C00001'}, 'secondaryIdInfos': [{'id': 'AZD0120', 'type': 'OTHER', 'domain': 'AstraZeneca'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'AZD0120', 'interventionNames': ['Biological: AZD0120']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B', 'description': '1 of the following 4 standard regimens per investigator choice; DKd, DPd, PVd, Kd.', 'interventionNames': ['Drug: Daratumumab', 'Drug: Carfilzomib', 'Drug: Dexamethasone', 'Drug: Bortezomib', 'Drug: Pomalidomide']}], 'interventions': [{'name': 'AZD0120', 'type': 'BIOLOGICAL', 'description': 'CAR-T Cells', 'armGroupLabels': ['Arm A']}, {'name': 'Daratumumab', 'type': 'DRUG', 'otherNames': ['Darzalex'], 'description': 'Daratumumab', 'armGroupLabels': ['Arm B']}, {'name': 'Carfilzomib', 'type': 'DRUG', 'otherNames': ['Kyprolis'], 'description': 'Carfilzomib', 'armGroupLabels': ['Arm B']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Dexamethasone', 'armGroupLabels': ['Arm B']}, {'name': 'Bortezomib', 'type': 'DRUG', 'otherNames': ['Velcade'], 'description': 'Bortezomib', 'armGroupLabels': ['Arm B']}, {'name': 'Pomalidomide', 'type': 'DRUG', 'otherNames': ['Pomalyst and Imnovid'], 'description': 'Pomalidomides', 'armGroupLabels': ['Arm B']}]}, 'contactsLocationsModule': 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