Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT06160167
Status:
COMPLETED
Last Update Posted:
2024-08-23
First Post:
2023-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incidence of Hyperpigmentation in Black Patients With Multiple Myeloma Treated With Immunomodulatory Drugs
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4204}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2023-11-29', 'studyFirstSubmitQcDate': '2023-11-29', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of hyperpigmentation in Black participants exposed to IMiDs to non-IMiDs for MM', 'timeFrame': '12 months', 'description': 'Each qualified patient must have at least 6 months of medical data recorded in the Flatiron database before the index date (pre-index period) and 6 months of available data on and after the index date (follow-up period).'}], 'secondaryOutcomes': [{'measure': 'Incidence of skin hyperpigmentation in Black, non-Black and all participants who received systemic treatment for MM', 'timeFrame': '12 months', 'description': 'Each qualified patient must have at least 6 months of medical data recorded in the Flatiron database before the index date (pre-index period) and 6 months of available data on and after the index date (follow-up period).'}, {'measure': 'Risk of skin hyperpigmentation in Black and non-Black participants diagnosed with MM and exposed to IMiDs', 'timeFrame': '12 months', 'description': 'Each qualified patient must have at least 6 months of medical data recorded in the Flatiron database before the index date (pre-index period) and 6 months of available data on and after the index date (follow-up period).'}, {'measure': 'Risk of skin hyperpigmentation in non-Black participants exposed to IMiDs versus non-IMiDs for MM', 'timeFrame': '12 months', 'description': 'Each qualified patient must have at least 6 months of medical data recorded in the Flatiron database before the index date (pre-index period) and 6 months of available data on and after the index date (follow-up period).'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure the incidence of hyperpigmentation in Black participants with multiple myeloma (MM) treated with immunomodulatory drugs (IMiDs) compared with Black participants with MM not treated with IMiDs. The study will use de-identified data from electronic medical records in the Flatiron Health database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Black and non-Black participants with MM', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants ≥18 years of age at index date\n* Participants with new diagnosis of MM as defined by:\n\n * ICD-9-CM: 203.0x and/or ICD-10-CM: C90.0x or C90 during the study period\n * At least two documented clinical visits for MM on different days and occurring on or after January 1, 2011\n* Participants who received at least one systemic MM therapy on or after initial MM diagnosis\n* Participants who did not receive clinical study drug at any time during the observation period\n* Participants with race information\n\nExclusion Criteria:\n\n* Exclusion Criteria\n* Patients with less than 6 months of medical data during the prior or follow-up period\n* Patients in more than one race category (mix race), missing race, unknown race, and "other" race\n* Patients diagnosed with the following hematological cancers on or prior to the index date:\n\n * myelodysplastic syndromes (ICD-9: 238.74, 238.75; ICD-10: D46.xx)\n * mantle cell lymphoma (ICD-9: 200.4x, ICD-10: C83.1x)\n * follicular lymphoma (ICD-9: 202.0x, ICD-10: C82.xx)\n * marginal zone lymphoma (ICD-9: 200.3x, ICD-10: C83.4x)\n* Patients with evidence of skin hyperpigmentation (ICD-9: 709.00, 709.09; ICD-10: L81.0, L81.1, L81.4, L81.8) on or prior to the index date\n\n * 709.00 Dyschromia, unspecified\n * 709.09 Other dyschromia\n * L81.0 Post inflammatory hyperpigmentation\n * L81.1 Chloasma/melasma\n * L81.4 Other melanin hyperpigmentation\n * L81.8 Other specified disorders of pigmentation'}, 'identificationModule': {'nctId': 'NCT06160167', 'briefTitle': 'Incidence of Hyperpigmentation in Black Patients With Multiple Myeloma Treated With Immunomodulatory Drugs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Incidence of Hyperpigmentation in Black Patients With Multiple Myeloma Treated With Immunomodulatory Drugs', 'orgStudyIdInfo': {'id': 'CA078-1007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with MM treated with IMiDs', 'interventionNames': ['Drug: IMiD treatment']}, {'label': 'Participants with MM not treated with IMiDs', 'interventionNames': ['Drug: No IMiD treatment']}, {'label': 'Participants with MM treated with systemic therapy', 'interventionNames': ['Drug: Systemic therapy']}], 'interventions': [{'name': 'IMiD treatment', 'type': 'DRUG', 'description': 'Participants with MM treated with IMiDs', 'armGroupLabels': ['Participants with MM treated with IMiDs']}, {'name': 'No IMiD treatment', 'type': 'DRUG', 'description': 'Participants with MM not treated with IMiDs', 'armGroupLabels': ['Participants with MM not treated with IMiDs']}, {'name': 'Systemic therapy', 'type': 'DRUG', 'description': 'Participants with MM treated with systemic therapy', 'armGroupLabels': ['Participants with MM treated with systemic therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10013', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Flatiron Health Oncology Database', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Bristol Myers-Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}