Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-02-21 @ 9:43 AM
Study NCT ID:
NCT06284395
Status:
RECRUITING
Last Update Posted:
2024-10-02
First Post:
2024-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Schemes Response in Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000210', 'term': 'Acute-Phase Reaction'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D000069286', 'term': 'Bortezomib'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 83}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Favorable Response', 'timeFrame': 'Post-induction (6 months)', 'description': 'Criteria established with the International Multiple Myeloma Working Group'}, {'measure': 'Time to next treatment', 'timeFrame': 'Post-induction (2 years)', 'description': 'Need for a secondline treatment after induction'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3000 days', 'description': 'Survivorship passing 3000 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Bortezomib', 'Thalidomide', 'Acute Phase Response', 'Survival'], 'conditions': ['Response, Acute Phase', 'Survivorship']}, 'referencesModule': {'references': [{'pmid': '31392724', 'type': 'BACKGROUND', 'citation': 'de Moraes Hungria VT, Martinez-Banos DM, Penafiel CR, Miguel CE, Vela-Ojeda J, Remaggi G, Duarte FB, Cao C, Cugliari MS, Santos T, Machnicki G, Fernandez M, Grings M, Ammann EM, Lin JH, Chen YW, Wong YN, Barreyro P. Multiple myeloma treatment patterns and clinical outcomes in the Latin America Haemato-Oncology (HOLA) Observational Study, 2008-2016. Br J Haematol. 2020 Feb;188(3):383-393. doi: 10.1111/bjh.16124. Epub 2019 Aug 7.'}, {'pmid': '33947178', 'type': 'BACKGROUND', 'citation': 'Mersin S, Geduk A, Mehtap O, Tarkun P, Unal S, Polat MG, Aygun K, Yenihayat EM, Albayrak H, Hacihanifioglu A. Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients. Turk J Haematol. 2021 Aug 25;38(3):211-217. doi: 10.4274/tjh.galenos.2021.2020.0555. Epub 2021 May 5.'}]}, 'descriptionModule': {'briefSummary': 'Retrospective study based on medical records of patients with multiple myeloma, eligible for stem cell transplantation, who received, first-line, the VTD or TD combination.', 'detailedDescription': 'The most current treatment of multiple myeloma is based on a combination of drugs, including immunomodulators, proteasome inhibitors, etc. The VTD (bortezomib, thalidomide, and dexamethasone) and TD (thalidomide and dexamethasone) regimens are commonly used as a first-line treatment due to limited resources. The study aimed to compare the proportion of favorable responses, survival, and time to the next treatment between two different treatment approaches. The investigators designed a retrospective study based on medical records of patients with multiple myeloma, eligible for stem cell transplantation, who received, first-line, the VTD or TD combination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Clinical records of patients diagnosed with multiple myeloma treated at Hospital General de México between 2020 and 2023.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical records of patients who were considered eligible for transplant due to their functional status and who were given some treatment strategy comprising a combination of drugs.\n\nExclusion Criteria:\n\n* Incomplete clinical records\n* Clinical records of patients who abandoned treatment or could not continue with the treatment due to economic or distance issues\n* Clinical records of patients who presented severe sepsis before the beginning of either treatment'}, 'identificationModule': {'nctId': 'NCT06284395', 'briefTitle': 'Two Schemes Response in Multiple Myeloma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital General de Mexico'}, 'officialTitle': 'Bortezomib, Thalidomide, and Dexamethasone Versus Thalidomide and Dexamethasone for Response Rates in Multiple Myeloma Patients: a Retrospective Study', 'orgStudyIdInfo': {'id': 'HGM1471-002/24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Group', 'description': 'Thalidomide 100mg-200mg PO daily alone or in combination with dexamethasone 40mg PO every 24 hours on days 1-4, 8-11 of each cycle.', 'interventionNames': ['Drug: Bortezomib']}, {'label': 'Bortezomib Group', 'description': 'Bortezomib 1.3mg/m2 SC on days 1,4, 8,11 to the TD scheme for a total of 6 treatment cycles (VTD).', 'interventionNames': ['Drug: Bortezomib']}], 'interventions': [{'name': 'Bortezomib', 'type': 'DRUG', 'otherNames': ['Intervention Group'], 'description': 'Bortezomib 1.3mg/m2 SC on days 1,4, 8,11 to the TD scheme for a total of 6 treatment cycles (14,15) (VTD)', 'armGroupLabels': ['Bortezomib Group', 'Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06720', 'city': 'Mexico City', 'state': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Christian O Ramos Peñafiel, PhD', 'role': 'CONTACT', 'email': 'leukemiachop33@gmail.com', 'phone': '5523351588'}, {'name': 'Adan G Gallardo Rodriguez', 'role': 'CONTACT', 'email': 'nutriologo.agallardo8@gmail.com', 'phone': '+525584005072'}, {'name': 'Juan M Cano Calderón, MD', 'role': 'CONTACT'}, {'name': 'Juan F Zazueta Pozos, MD', 'role': 'CONTACT'}, {'name': 'Adán G Gallardo Rodriguez, PhD', 'role': 'CONTACT'}, {'name': 'Carlos Martínez Murillo, PhD', 'role': 'CONTACT'}, {'name': 'Irma Olarte Carrillo, PhD', 'role': 'CONTACT'}, {'name': 'Adolfo Martínez Tovar, PhD', 'role': 'CONTACT'}, {'name': 'Christian O Ramos Peñafiel, PhD', 'role': 'CONTACT'}], 'facility': 'Hospital General de Mexico Dr. Eduardo Liceaga', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Christian O Ramos Peñafiel, PhD', 'role': 'CONTACT', 'email': 'leukemiachop33@gmail.com', 'phone': '+52 55 27892000', 'phoneExt': '2020'}, {'name': 'Adán G Gallardo Rodriguez, PhD', 'role': 'CONTACT', 'email': 'nutriologo.agallardo8@gmail.com', 'phone': '+52 55 27892000', 'phoneExt': '2020'}], 'overallOfficials': [{'name': 'Adolfo O Martinez Tovar, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital General de México Dr. Eduardo Liceaga'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All participants and their information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General de Mexico', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Christian Omar Ramos-Peñafiel, MD, PhD', 'investigatorAffiliation': 'Hospital General de Mexico'}}}}