Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-25 @ 7:28 PM
Study NCT ID:
NCT05804032
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-07
First Post:
2023-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lenalidomide, Bortezomib and Dexamethasone Induction Therapy with Either Intravenous or Subcutaneous Isatuximab in Patients with Newly Diagnosed Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000599209', 'term': 'isatuximab'}, {'id': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'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': 'D011719', 'term': 'Pyrazines'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 514}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-07-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2023-03-21', 'studyFirstSubmitQcDate': '2023-04-04', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demonstration of non-inferiority of subcutaneous (SC) isatuximab compared to intravenous (IV) isatuximab, both in combination with RVd.', 'timeFrame': '18 weeks after start of study treatment', 'description': 'Rates of VGPR or better (according to standard IMWG response criteria), defined as proportion of patients with at least VGPR after induction therapy (according to standard International Myeloma Working Group (IMWG) response criteria).'}], 'secondaryOutcomes': [{'measure': 'Quality of life compared between Arm A and B.', 'timeFrame': '18 weeks after start of study treatment', 'description': 'Comparison of PRO (patient-reported outcome) regarding route of administration of isatuximab (SC vs. IV) on induction therapy as assessed by modified CTSQ (modified 9-item questionnaire)'}, {'measure': 'Non-inferiority of rates of MRD negativity in Arm B compared to Arm A', 'timeFrame': '18 weeks after start of study treatment', 'description': 'Rates of NGS-MRD negativity (sensitivity 10\\^-5, from bone marrow aspirate) after induction therapy'}, {'measure': 'Rates of MRD negativity by NGS and NGF (sensitivity 10^-5, from BMA) independent of standard IMWG response after first HDM/ASCT', 'timeFrame': '18 weeks (timepoint "after induction") or 35 weeks (timepoint "after first HDM/ASCT") after start of study treatment', 'description': 'defined as proportion of negative patients with the corresponding MRD method (NGS or NGF) at the defined timepoint (after induction therapy or first HDM/ASCT)'}, {'measure': 'Rates of best overall response to treatment (BOR)', 'timeFrame': 'Depending on the timepoint of best response out of all response assessments, up to 10 months from randomization', 'description': 'proportion of patients with BOR (at least PR or better) to treatment until end of study (based on timepoints post induction cycle 2 and 3, prior to HDM/ASCT and post first HDM/ASCT)'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Until EOS (28 months after start of study)', 'description': 'Time from randomization (at study inclusion) to progression or death from any cause whichever occurs first'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neoplasms', 'Paraproteinemias', 'Lymphoproliferative Disorders', 'Immunoproliferative Disorders', 'Lenalidomide', 'Bortezomib', 'Dexamethasone', 'Isatuximab', 'Monoclonal antibodies'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'The trial aims to demonstrate the non-inferiority of subcutaneous to intravenous isatuximab administration in transplant-eligible patients with newly diagnosed multiple myeloma.', 'detailedDescription': 'Prospective, multicentre, randomised, parallel group, open, phase III clinical trial, for patients with confirmed diagnosis of untreated multiple myeloma requiring systemic therapy.\n\nInvestigational Medicinal Product: Isatuximab, subcutaneous administration via a wearable injector system.\n\nRandomization: Patients are randomized in one of 2 study arms (A or B) before induction therapy. Patients randomized in arm A will receive 3 cycles of the monoclonal antibody isatuximab intravenously, combined with RVd regimen (Lenalidomide, Bortezomib, Dexamethasone). Each cycle will last for 42 days. Patients in arm B will receive 3 cycles RVd plus isatuximab subcutaneously. After induction therapy, patients will receive standard intensification (usually cyclophosphamide-based mobilization therapy, stem cell collection and high-dose melphalan followed by autologous stem cell transplantation (HDM/ASCT)). End of study will be after the first HDM/ASCT.\n\nThere is one primary objective:\n\nDemonstration of non-inferiority of subcutaneous (SC) isatuximab compared to intravenous (IV) isatuximab, both in combination with RVd, with respect to rates of VGPR or better after induction therapy (according to standard International Myeloma Working Group (IMWG) response criteria).\n\nKey secondary objectives are:\n\n1. Comparison of patient-reported outcomes (PRO) regarding route of administration of isatuximab (SC vs. IV) on induction therapy as assessed by modified CTSQ (modified 9-item questionnaire).\n2. Non-inferiority of rates of MRD negativity (assessed by NGS from BMA; sensitivity 10\\^-5) independent of standard IMWG response after induction therapy.\n\nThe duration of the trial for each patients is expected to be approximately 10 months (induction and intensification treatment).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of untreated MM requiring systemic therapy (diagnostic criteria according to IMWG)\n* Patient is eligible for high-dose melphalan (200 mg/m\\^2 melphalan) and autologous stem cell transplantation\n* Measurable MM disease according to IMWG criteria, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements: serum M-protein ≥ 10 g/L; urine light-chain (M-protein) of ≥ 200 mg/24 hours; involved FLC level ≥ 10 mg/dL provided sFLC ratio is abnormal\n* Age 18-70 years at trial inclusion\n\nExclusion Criteria:\n\n* Patient has known hypersensitivity (or contraindication) to any of the components of study therapy\n* Systemic amyloid light-chain amyloidosis (except for localized AL amyloidosis limited to the skin or the bone marrow)\n* Plasma cell leukemia\n* Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local MM progression\n* Severe cardiac dysfunction (NYHA classification III-IV)\n* Patients with active or uncontrolled hepatitis B or C or detectable liver disease due to hepatitis B or C\n* HIV positivity\n* Patients with active, uncontrolled infections\n* Patients with severe renal insufficiency or requiring hemodialysis\n* Patients with peripheral neuropathy or neuropathic pain, grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events)\n* Patients with a history of any active malignancy during the past 5 years with the exception of following malignancies after curative therapy: basal cell carcinoma of the skin, squamous cell skin carcinoma, stage 0 cervical carcinoma or any in situ malignancy\n* Platelet count \\< 75 x 10\\^9/L\n* Haemoglobin ≤ 8.0 g/dL, unless related to MM\n* Absolute neutrophil count (ANC) \\< 1.0 x 10\\^9/L (the use of colony stimulating factors within 14 days before the test is not allowed)\n* Corrected serum calcium \\> 14 mg/dL (\\> 3.5 mmol/L)\n* Pregnancy and lactation\n\nFor further details on inclusion/exclusion criteria please refer to the study protocol.'}, 'identificationModule': {'nctId': 'NCT05804032', 'briefTitle': 'Lenalidomide, Bortezomib and Dexamethasone Induction Therapy with Either Intravenous or Subcutaneous Isatuximab in Patients with Newly Diagnosed Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'University of Heidelberg Medical Center'}, 'officialTitle': 'A Randomized Phase III Non-inferiority Trial Assessing Lenalidomide, Bortezomib and Dexamethasone Induction Therapy with Either Intravenous or Subcutaneous Isatuximab in Transplant-eligible Patients with Newly Diagnosed Multiple Myeloma.', 'orgStudyIdInfo': {'id': 'GMMG-HD8/DSMM XIX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A - Intravenous isatuximab', 'description': 'Patients in arm A are treated with 3 cycles RVd + i.v. isatuximab, followed by a standard intensification and autologous stem cell transplantation.', 'interventionNames': ['Drug: Isatuximab', 'Drug: Lenalidomide', 'Drug: Bortezomib', 'Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B - Subcutaneous isatuximab', 'description': 'Patients in arm B are treated with 3 cycles RVd + s.c. isatuximab, followed by a standard intensification and autologous stem cell transplantation.', 'interventionNames': ['Drug: Isatuximab', 'Drug: Lenalidomide', 'Drug: Bortezomib', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Isatuximab', 'type': 'DRUG', 'otherNames': ['Sarclisa'], 'description': 'IV isatuximab will be administered weekly in the first cycle (Cycle 1) on days 1, 8, 15, 22, 29, and biweekly on the 2 subsequent cycles at days 1, 15 and 29, at the dose of 10 mg/kg.', 'armGroupLabels': ['Arm A - Intravenous isatuximab']}, {'name': 'Isatuximab', 'type': 'DRUG', 'otherNames': ['Sarclisa'], 'description': 'SC isatuximab will be administered on days 1, 8, 15, 22, 29 of cycle 1, and on days 1, 15 and 29 of cycles 2-3, at the dose of 1400 mg', 'armGroupLabels': ['Arm B - Subcutaneous isatuximab']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'description': 'Both arms: 25 mg per os on day 1-14 and d22-35 in induction cycle 1-3', 'armGroupLabels': ['Arm A - Intravenous isatuximab', 'Arm B - Subcutaneous isatuximab']}, {'name': 'Bortezomib', 'type': 'DRUG', 'otherNames': ['Velcade'], 'description': 'Both arms: 1.3 mg/m\\^2 subcutaneous on day 1, 4, 8, 11, 22, 25, 29 32 in 3 induction cycles', 'armGroupLabels': ['Arm A - Intravenous isatuximab', 'Arm B - Subcutaneous isatuximab']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': '20 mg per os on day 1-2, 4-5, 8-9, 11-12, 15; and 22-23, 25-26, 29-30, 32-33 in induction cycles 1-3.', 'armGroupLabels': ['Arm A - Intravenous isatuximab', 'Arm B - Subcutaneous isatuximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3500', 'city': 'Krems', 'country': 'Austria', 'facility': 'Universitätsklinikum Krems', 'geoPoint': {'lat': 48.40921, 'lon': 15.61415}}, {'zip': '4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Ordensklinikum Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '6830', 'city': 'Rankweil', 'country': 'Austria', 'facility': 'Landeskrankenhaus Feldkirch-Rankweil', 'geoPoint': {'lat': 47.27108, 'lon': 9.64308}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Universitätsklinikum der Paracelsus, 3. Med. Abteilung/Onkologie Ambulanz', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '3100', 'city': 'Sankt Pölten', 'country': 'Austria', 'facility': 'Universitätsklinikum St. Pölten - Lilienfeld', 'geoPoint': {'lat': 48.20762, 'lon': 15.63725}}, {'zip': '4400', 'city': 'Steyr', 'country': 'Austria', 'facility': 'Phyrn-Eisenwurzen Klinikum Steyr', 'geoPoint': {'lat': 48.04274, 'lon': 14.42127}}, {'zip': '1160', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Klinik Ottakring', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '4600', 'city': 'Wels', 'country': 'Austria', 'facility': 'Klinikum Wels-Grieskirchen', 'geoPoint': {'lat': 48.16667, 'lon': 14.03333}}, {'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Uniklinik RWTH Aachen, Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '20099', 'city': 'Altona', 'country': 'Germany', 'facility': 'Asklepios Kliniken Hamburg GmbH', 'geoPoint': {'lat': 53.55, 'lon': 9.93333}}, {'zip': '86156', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Klinikum Augsburg, II. Medizinische Klinik Hämatologie/Onkologie', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '15526', 'city': 'Bad Saarow', 'country': 'Germany', 'facility': 'Helios Klinikum Bad Saarow, Klinik für Hämatologie, Onkologie und Palliativmedizin', 'geoPoint': {'lat': 52.28333, 'lon': 14.06667}}, {'zip': '95445', 'city': 'Bayreuth', 'country': 'Germany', 'facility': 'MedZentrum Klinikum Bayreuth GmbH', 'geoPoint': {'lat': 49.94782, 'lon': 11.57893}}, {'zip': '12200', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité, III. Medizinische Abteilung (Hämatologie/Onkologie)', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12351', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Vivantes Klinikum Neukölln, Klinik für Hämatologie und Onkologie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13125', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Klinik für Hämatologie und Stammzelltransplantation, Helios Klinikum Berlin-Buch', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13585', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Vivantes Klinikum Spandau', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '33604', 'city': 'Bielefeld', 'country': 'Germany', 'facility': 'Bielefeld Praxis, Studiengesellschaft Onkologie', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'zip': '33611', 'city': 'Bielefeld', 'country': 'Germany', 'facility': 'Evangelisches Klinikum Bethel', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'zip': '53113', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Johanniter-Krankenhaus Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitätsklinikum Bonn, Medizinische Klinik III', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '38114', 'city': 'Braunschweig', 'country': 'Germany', 'facility': 'Städtisches Klinikum Braunschweig', 'geoPoint': {'lat': 52.26594, 'lon': 10.52673}}, {'zip': '28205', 'city': 'Bremen', 'country': 'Germany', 'facility': 'Klinikum Bremen-Mitte', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': '09116', 'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Klinikum Chemnitz gGmbH', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitätsklinikum Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '03048', 'city': 'Cottbus', 'country': 'Germany', 'facility': 'Carl-Thiem-Klinikum Cottbus gGmbH, 2. Medizinische Klinik', 'geoPoint': {'lat': 51.75769, 'lon': 14.32888}}, {'zip': '64283', 'city': 'Darmstadt', 'country': 'Germany', 'facility': 'Klinikum Darmstadt, Medizinische Klinik V Hämatologie/Onkologie', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'zip': '06847', 'city': 'Dessau', 'country': 'Germany', 'facility': 'Städtisches Klinikum Dessau', 'geoPoint': {'lat': 51.83864, 'lon': 12.24555}}, {'zip': '44137', 'city': 'Dortmund', 'country': 'Germany', 'facility': 'St.-Johannes-Hospital', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik I', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '47166', 'city': 'Duisburg', 'country': 'Germany', 'facility': 'Helios St. Johannes Klinik Duisburg, Medizinische Klinik 2', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Universitätsklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '40479', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Marien Hospital Düsseldorf GmbH, Klinik für Onkologie, Hämatalogie und Palliativmedizin', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '52249', 'city': 'Eschweiler', 'country': 'Germany', 'facility': 'St. Antonius-Hospital Eschweiler, Klinik für Hämatologie / Onkologie', 'geoPoint': {'lat': 50.81854, 'lon': 6.27184}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '45239', 'city': 'Essen', 'country': 'Germany', 'facility': 'KEM I Evang. 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