Ignite Creation Date:
2025-12-17 @ 2:47 PM
Ignite Modification Date:
2025-12-23 @ 4:54 PM
Study NCT ID:
NCT06649695
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2024-10-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075363', 'term': 'Immunoglobulin Light-chain Amyloidosis'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2024-10-18', 'studyFirstSubmitQcDate': '2024-10-18', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hematologic Complete Response (CR) rate', 'timeFrame': 'baseline up to 3 cycles of treatment (approximately 3 months)', 'description': 'Percentage of participants achieving CR or better according to EHA/ISA guidelines'}], 'secondaryOutcomes': [{'measure': 'Hematologic Overall Response Rate (ORR) rate', 'timeFrame': 'Baseline up to progression of disease or death (approximately 3,5 years)', 'description': 'Percentage of participants achieving Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) or better according to EHA/ISA guidelines'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['teclistamab'], 'conditions': ['AL Amyloidosis']}, 'descriptionModule': {'briefSummary': 'This is a multicenter open-label, phase 2 study in participant with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the benefit of teclistamab'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologic diagnosis of AL amyloidosis and typed with immunohistochemistry/ immunofluorescence, immunoelectron microscopy, or mass spectrometry. In patients with biopsy-confirmed amyloidosis, ambiguous amyloid typing results, and cardiac involvement alone, a negative pyrophosphate (PYP) or technetium-99m (99mTc) and 3,3-diphosphono-1,2-propanodicarboxylic acid (DPD-Tc99m) bone scan is required to distinguish cardiac involvement due to AL amyloidosis from amyloid transthyretin (ATTR) amyloidosis. Data from the initial diagnosis are accepted.\n* Genetic testing must be negative for transthyretin mutations associated with hereditary amyloidosis, or immunohistochemistry/ immunofluorescence/ immunoelectron microscopy/ mass spectrometry of amyloid deposits must provide clear evidence of κ or λ light chains in patients who present with peripheral neuropathy or heart as the dominant organ involvement. Data from the initial diagnosis are accepted.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2\n* Mayo stage I-IIIA cardiac disease at Screening\n* Relapsed patients must have received at least 1 line of treatment, including Dara and bortezomib. Patients must have received at least two cycles of therapy. However, patients who have received high-dose therapy with melphalan as their only therapy are also eligible.\n* Measurable hematologic disease: a dFLC \\>20 mg/L with an abnormal κ/λ ratio (with Freelite® test kits, The Binding Site) or presence of a monoclonal spike ≥0.5 g/dL.\n* Adequate bone marrow function, without transfusion or growth factors within 5 days prior to the first drug intake (C1D1), defined as:\n* Absolute neutrophils ≥1,000/mm3,\n* Platelets ≥75,000/mm3,\n* Hemoglobin ≥8.5 g/dL.\n* Adequate organ function, defined as:\n* Serum creatinine clearance (CKD-EPI formula) ≥20 mL/min,\n* Serum SGPT/ALT \\<5.0 x Upper Limit of Normal (ULN),\n* Serum total bilirubin \\<2.0 mg/dL or direct bilirubin ≤30% of the total, unless the patient has Gilbert's syndrome, where direct bilirubin should then be \\<2.0 mg/dL,\n* Serum albumin ≥\\<2.5 gr/dl (medication to correct serum albumin levels is permitted).\n\nExclusion Criteria:\n\n* Amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura, as the only evidence of disease. The finding of isolated vascular amyloid in a bone marrow biopsy specimen or in a plasmacytoma is not indicative of systemic amyloidosis.\n* Isolated soft-tissue involvement.\n* Presence of non-AL amyloidosis.\n* Previous anti-BCMA targeted therapy (including, but not limited to, bispecifics).\n* Intolerance to dexamethasone that would prohibit treatment with trial therapy.\n* MM diagnosed as per the International Myeloma Working Group (IMWG) criteria, with the exception of monoclonal gammopathy of unknown significance (MGUS) or smoldering Myeloma, not requiring treatment.\n\nNote: A MM diagnosis with a serum FLC ratio \\>100, as the only myeloma-defining event, does NOT constitute an exclusion.\n\n* All hematologic malignancies, with the exception of low-risk Philadelphia chromosome negative (Ph-) myeloproliferative neoplasms (MPNs) and low-risk myelodysplastic syndromes (MDS), not requiring treatment.\n* Mayo stage IIIB cardiac disease at Screening"}, 'identificationModule': {'nctId': 'NCT06649695', 'briefTitle': 'A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis', 'organization': {'class': 'NETWORK', 'fullName': 'European Myeloma Network B.V.'}, 'officialTitle': 'A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis', 'orgStudyIdInfo': {'id': 'EMN40/64007957AMY2002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teclistamab', 'description': 'Teclistamab will be administered via a subcutaneous injection (SC)', 'interventionNames': ['Drug: Teclistamab']}], 'interventions': [{'name': 'Teclistamab', 'type': 'DRUG', 'otherNames': ['JNJ-64007957'], 'description': 'Teclistamab will be administered via a subcutaneous injection (SC)', 'armGroupLabels': ['Teclistamab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adelaide', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Horvath', 'role': 'CONTACT'}], 'facility': 'South Australia Health', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Sydney', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Kwok', 'role': 'CONTACT'}], 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Limoges', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Roussel', 'role': 'CONTACT'}], 'facility': 'CHU Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arnulf', 'role': 'CONTACT'}], 'facility': 'Paris St Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Essen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Carpinteiro', 'role': 'CONTACT'}], 'facility': 'University Hospital Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Schönland', 'role': 'CONTACT'}], 'facility': 'University Hospital Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Würzburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Kortüm', 'role': 'CONTACT'}], 'facility': 'University Hospital Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Kastritis', 'role': 'CONTACT'}], 'facility': 'General Hospital of Athens "Alexandra"', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Pavia', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Palladini', 'role': 'CONTACT'}], 'facility': 'Fondazione I.R.C.C.S Policlinico "San Matteo"', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Minnema', 'role': 'CONTACT'}], 'facility': 'UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'centralContacts': [{'name': 'Sarah Lonergan', 'role': 'CONTACT', 'email': 'sarah.lonergan@emn.org', 'phone': '+31 102687065'}, {'name': 'Emelie Asselbergs', 'role': 'CONTACT', 'email': 'emelie.asselbergs@emn.org', 'phone': '+31 102687065'}], 'overallOfficials': [{'name': 'Murielle Roussel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Limoges'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Myeloma Network B.V.', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Janssen Research & Development', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}