Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT05996367
Status:
RECRUITING
Last Update Posted:
2023-08-18
First Post:
2023-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Cohort of Single-dose Radiotherapy for Painful Bone Lesions in 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2029-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-09', 'studyFirstSubmitDate': '2023-07-31', 'studyFirstSubmitQcDate': '2023-08-09', 'lastUpdatePostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retreatment rate at 6 months', 'timeFrame': '6 months after radiotherapy', 'description': 'Percentage of patients that needed a second corse of radiation for painful bone lesions'}], 'secondaryOutcomes': [{'measure': 'Local control', 'timeFrame': '6 months and 12 months', 'description': 'Local control by Recist 1.1'}, {'measure': 'Progression-free survival', 'timeFrame': '12 months', 'description': 'Progression-free survival'}, {'measure': 'Overall survival', 'timeFrame': '12 months', 'description': 'Overall survival'}, {'measure': 'Bone event-free survival', 'timeFrame': '6 months', 'description': 'by description from Raje et al. The Lancet 2018'}, {'measure': 'Pain relief by the numerical rating pain scale', 'timeFrame': '1, 3, 6 and 12 months', 'description': 'reduction on opioid and single analgesics intake and altered value in the rating pain scale'}, {'measure': 'Pain flair incidence', 'timeFrame': '1, 3, 6 and 12 months', 'description': 'Enhanced pain by at least 2 levels at the numerical rating pain scale'}, {'measure': 'Quality of life by EORCT QLQ-C30', 'timeFrame': '1, 6 and 12 months', 'description': 'Quality of life by EORCT QLQ-C30 questionnaire'}, {'measure': 'Quality of life by EORCT QLQ-C30 and MY-24', 'timeFrame': '1, 6 and 12 months', 'description': 'Quality of life by EORCT MY-24 myeloma complementary questionnaires'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple myeloma', 'Palliative care', 'Radiotherapy'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'Multiple myeloma is a plasma cell neoplasm that can cause painful bone lesions. The main treatment for these lesions and pain control is radiotherapy, usually in daily fractions. In 2017, a phase III study proved the effectiveness of using a single dose of 8 Gy, but without description of several important oncological outcomes. This is a single-arm prospective cohort study. This study aims to describe these outcomes, including retreatment rate and bone events. Also, as secondary objectives, describe the quality of life and use of analgesic medications in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy of plasma cell neoplasm with bone lesion treatable with radiotherapy;\n* Age between 18 and 85 years old;\n* Performance on the ECOG scale less than or equal to 2.\n* Not using systemic therapies for 4 weeks OR being on maintenance therapy with the same drug for at least 4 weeks before radiotherapy.\n\nExclusion Criteria:\n\n* Refusing to sign or inability to understand the consent term;\n* Pain less than 2/10 on the numeric pain rating scale;\n* Change in systemic treatment scheme, including use of bone metabolism modulation drugs, up to 4 weeks before radiotherapy treatment;\n* Technical incapacity for the treatment, including, but not limited to, weight greater than 115Kg, inability to abduct the limb to be treated in appendicular bones, intolerable pain to remain in the treatment position;\n* Previous cancer and previous oncological treatments;\n* Previous autoimmune diseases, even if controlled;\n* Current pregnancy.'}, 'identificationModule': {'nctId': 'NCT05996367', 'briefTitle': 'Prospective Cohort of Single-dose Radiotherapy for Painful Bone Lesions in Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Instituto do Cancer do Estado de São Paulo'}, 'officialTitle': 'Prospective Cohort Assessing the Impact of Single-dose Radiotherapy in the Treatment of Painful Bone Lesions in Patients With Multiple Myeloma', 'orgStudyIdInfo': {'id': 'NP 465/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'description': 'Single-dose radiation to involved-site', 'interventionNames': ['Radiation: Single-dose involved-site radiotherapy']}], 'interventions': [{'name': 'Single-dose involved-site radiotherapy', 'type': 'RADIATION', 'description': 'Single-dose of 8 Gy at involved-site radiotherapy', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-010', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Geovanne Mauro, PhD', 'role': 'CONTACT', 'email': 'geovanne.mauro@hc.fm.usp.br', 'phone': '+551126617058'}], 'facility': 'University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Geovanne P Mauro, PhD', 'role': 'CONTACT', 'email': 'geovanne.mauro@hc.fm.usp.br', 'phone': '+551126617058'}], 'overallOfficials': [{'name': 'Geovanne P Mauro, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto do Cancer do Estado de São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Geovanne Pedro Mauro', 'investigatorAffiliation': 'Instituto do Cancer do Estado de São Paulo'}}}}