Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-27 @ 3:53 AM
Study NCT ID:
NCT06668792
Status:
RECRUITING
Last Update Posted:
2025-02-04
First Post:
2024-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Patients With Relapsed/Refractory Multiple Myeloma
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2024-10-30', 'studyFirstSubmitQcDate': '2024-10-30', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate according to IMWG (International Myeloma Working Group) criteria', 'timeFrame': 'Up to 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Complete response (CR) rate according to IMWG criteria', 'timeFrame': 'Up to 3.7 years'}, {'measure': 'MRD (minimal residual disease)-negativity rate', 'timeFrame': 'Up to 3.7 years'}, {'measure': 'Duration of response', 'timeFrame': 'Up to 3.7 years'}, {'measure': 'Time to progression', 'timeFrame': 'Up to 3.7 years'}, {'measure': 'Time to response', 'timeFrame': 'Up to 3.7 years'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 3.7 years'}, {'measure': 'Incidence and characteristics of adverse events', 'timeFrame': 'Up to 3.7 years'}, {'measure': 'Cmax after the first administration', 'timeFrame': 'up to Day 6'}, {'measure': 'Cmin after the first administration', 'timeFrame': 'up to Day 6'}, {'measure': 'AUC0-t after the first administration', 'timeFrame': 'up to Day 6'}, {'measure': 'Ctrough', 'timeFrame': 'up to 6 months'}, {'measure': 'Soluble BCMA concentration in the blood', 'timeFrame': 'Up to 6 months'}, {'measure': 'Proportion of subjects with BAbs', 'timeFrame': 'Up to 3 years'}, {'measure': 'Proportion of subjects with NAbs', 'timeFrame': 'Up to 3 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed/Refractory Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the efficacy and safety of BCD-248 as a therapy for relapsing and/or refractory multiple myeloma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed informed consent form.\n2. Age ≥18 years.\n3. Documented diagnosis of multiple myeloma according to the IMWG criteria.\n4. Measurable disease at screening.\n5. Subjects who received at least 2 lines of therapy for multiple myeloma, including a proteasome inhibitor, an immunomodulatory drug, anti-CD38 therapy.\n6. Documented progression according to the IMWG criteria during or after the last line of therapy.\n7. Evidence of at least a partial response according to the IMWG criteria to at least 1 previous line of therapy.\n8. ECOG score 0-2.\n\nExclusion Criteria:\n\n1. Subjects who were previously treated with anti-BCMA or anti-CD3 drugs.\n2. Use of any investigational medicinal products or medical devices within 30 days or 5 half-lives (whichever is longer) prior to the expected start of the study therapy or planned use of investigational medicinal products or medical devices during participation in this study, except for the use described in this Protocol.\n3. Autologous hematopoietic stem cell transplantation within 12 weeks prior to the expected start of the study therapy or a history of allogenic stem cell transplantation, regardless of when it was performed.\n4. Planned hematopoietic stem cell transplantation before disease progression during this study.\n5. A history of other malignancies within 5 years before screening, excluding squamous and basal cell skin cancers, carcinoma in situ of the cervix or breast, or other malignancies, which, in the opinion of the Investigator, have been adequately treated and have a minimal risk of recurrence within 5 years.\n6. Concomitant diseases and/or conditions that significantly increase the risk of AEs during the study:\n\n * Stable angina pectoris, functional class III-IV.\n * Unstable angina and/or myocardial infarction within less than 6 months before the expected start of the study therapy.\n * Chronic heart failure, NYHA class III-IV;\n * Clinically significant (in the Investigator's opinion) cardiac arrhythmia and conduction disorders that do not respond to the maximum possible antiarrhythmic therapy (therapy should be stable for 4 weeks before the expected start of the study therapy);\n * Moderate to severe asthma, grade III-IV chronic obstructive pulmonary disease, a history of angioedema, severe respiratory failure;\n * Active autoimmune diseases (subjects with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, as well as with skin diseases (vitiligo, alopecia, or psoriasis) that do not require systemic therapy are eligible);\n * Any infection within 14 days prior to the expected start of the study therapy, requiring systemic etiotropic therapy or which, in the opinion of the Investigator, may increase the risk of infectious complications;\n * Any other concomitant disease or condition, which, in the Investigator's opinion, significantly increases the risk of AEs in the study.\n7. Subjects with amyloidosis.\n8. Clinical signs of meningeal involvement of multiple myeloma.\n9. HIV infection, active HBV infection, hepatitis C.\n10. Major surgery within less than 14 days prior to the expected start of the study therapy, incomplete recovery from surgery, or planned surgery during participation in the study.\n11. Pregnancy or breastfeeding, as well as intention to become pregnant or father a child during the study period and within 180 days after receiving the last dose of the IP."}, 'identificationModule': {'nctId': 'NCT06668792', 'acronym': 'FLAMMINGO', 'briefTitle': 'An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Patients With Relapsed/Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biocad'}, 'officialTitle': 'An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Subjects With Relapsed/Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'BCD-248-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BCD-248', 'interventionNames': ['Drug: BCD-248']}], 'interventions': [{'name': 'BCD-248', 'type': 'DRUG', 'description': 'subcutaneously', 'armGroupLabels': ['BCD-248']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kaliningrad', 'status': 'NOT_YET_RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Alina Chuprakova', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SBHI of the Kaliningrad region "Central City Clinical Hospital"', 'geoPoint': {'lat': 54.70639, 'lon': 20.51102}}, {'city': "Kazan'", 'status': 'NOT_YET_RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Gulnara Husainova', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SAHI "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigala"', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Kirov', 'status': 'NOT_YET_RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Svetlana Samarina', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'FSBI of science "Kirov research Institute of Hematology and blood transfusion of the Federal medical and biological Agency"', 'geoPoint': {'lat': 58.59809, 'lon': 49.65783}}, {'city': 'Krasnoyarsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Elena Martynova', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Regional Government-Owned Publicly Funded Healthcare Institution "Regional Clinical Hospital"', 'geoPoint': {'lat': 56.03742, 'lon': 92.93136}}, {'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Igor Utiashev', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Branch of the limited liability company "Hadassah Medical LTD"', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Elena Misiurina', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'City Clinical Hospital №52 of the Department of Health of the City of Moscow', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'status': 'NOT_YET_RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Gaiane Tumian', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'FSBI "National Medical Research Center of Oncology named after N. N. Blokhin" of the Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Anastasia Mochalova', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'JSC "Medsi Group of Companies"', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'status': 'NOT_YET_RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Vadim Doronin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SBI of health care of the city of Moscow city clinical hospital named after S. P. Botkin of the Department of health of the City of Moscow', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'status': 'NOT_YET_RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Tatiana Mitina', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'State budgetary healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M. F. Vladimirsky"', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Obninsk', 'status': 'NOT_YET_RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Natalia Falaleeva', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 55.10993, 'lon': 36.61238}}, {'city': 'Petrozavodsk', 'status': 'NOT_YET_RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Aleksandr Miasnikov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SBHI of the Republic of Karelia "Republican Hospital named after V.A. Baranov"', 'geoPoint': {'lat': 61.78491, 'lon': 34.34691}}, {'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Yurii Osipov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'FSBI "Almazov National Medical Research Centre" of the Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Samara', 'status': 'NOT_YET_RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Igor Davidkin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'FSBEI of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'city': 'Saratov', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Tatiana Shelekhova', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'FSBEI HE "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of Russia', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'city': 'Smolensk', 'status': 'NOT_YET_RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Mariia Novikova', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Smolensk"', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'city': 'Sochi', 'status': 'NOT_YET_RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Dmitrii Kirtbaia', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'State Budgetary Healthcare Institution "Oncological Dispensary No.2" of the Ministry of Health of the Krasnodar Region', 'geoPoint': {'lat': 43.59699, 'lon': 39.72477}}, {'city': 'Syktyvkar', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Andrei Proidakov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Public institution "Komi Republican cancer clinic"', 'geoPoint': {'lat': 61.66393, 'lon': 50.8163}}, {'city': 'Ufa', 'status': 'NOT_YET_RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Bulat Bakirov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'FSBEI of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'city': 'Yekaterinburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Tatiana Konstantinova', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'State budgetary healthcare institution of the Sverdlovsk region "Sverdlovsk regional clinical hospital №1"', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}], 'centralContacts': [{'name': 'Daria Liaptseva', 'role': 'CONTACT', 'email': 'liaptseva@biocad.ru', 'phone': '+79816982050'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biocad', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}