Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:15 AM
Study NCT ID:
NCT07391761
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real World Study of Elranatamab in Patients With RR Multiple Myeloma in Taiwan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2026-01-29', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rwTTR (real-world time to response)', 'timeFrame': 'At 1 month, 3 months, 6 months, 9 months, 12 months, and 18 months following initiation of elranatamab treatment (index date.)', 'description': 'Time from index date to the first documented real-world response.'}, {'measure': 'rwORR (real-world overall response rate)', 'timeFrame': 'At 1 month, 3 months, 6 months, 9 months, 12 months, and 18 months following initiation of elranatamab treatment (index date.)', 'description': 'Proportion of patients achieving real-world overall response at predefined assessment time points.'}, {'measure': 'rwDOR (real-world duration of response）', 'timeFrame': 'From first response until 18 months', 'description': 'Time from the first documented real-world response to real-world disease progression, death, or end of study.'}, {'measure': 'rwPFS (real-world progression-free survival)', 'timeFrame': 'From initiation of elranatamab treatment (index date) until 18 months', 'description': 'Time from index date to the first documented real-world disease progression or death.'}, {'measure': 'rwOS (real world overall survival)', 'timeFrame': 'From initiation of elranatamab treatment (index date) until 18 months', 'description': 'Time from index date to death from any cause.'}, {'measure': 'rwTTNT (real world time to next treatment)', 'timeFrame': 'From initiation of elranatamab treatment (index date) until 18 months', 'description': 'Time from index date to initiation of the next line of anti-myeloma therapy or end of study.'}], 'secondaryOutcomes': [{'measure': 'Demographic: Age', 'timeFrame': 'At baseline', 'description': 'Age (measured in years)'}, {'measure': 'Demographic: Sex', 'timeFrame': 'From MM diagnosis until index date, and from index date until 18 months', 'description': 'sex/gender (male/female)'}, {'measure': 'Anthropometric Measures', 'timeFrame': 'At baseline', 'description': 'Height (in cm), weight (in kg), BMI (kg/m²),'}, {'measure': 'ECOG Performance Status', 'timeFrame': 'At baseline', 'description': 'Number and proportion of patients in each ECOG PS category (0-5)'}, {'measure': 'Myeloma-related Clinical Characteristics', 'timeFrame': 'At baseline', 'description': 'Baseline disease characteristics including myeloma type (IgG, non-IgG, light-chain, non-secretory), bone marrow plasma cell %, presence of EMD, ECOG status, CRAB symptoms, ISS/R-ISS stage, MGUS, SMM, and cytogenetic risk.'}, {'measure': 'Laboratory Characteristics', 'timeFrame': 'At baseline', 'description': 'Baseline laboratory result of creatinine clearance (CrCl) categories (stages 1-5 or \\<30/≥30 mL/min)'}, {'measure': 'Prior Treatment History', 'timeFrame': 'At baseline', 'description': 'Number and proportion of patients with prior ASCT, prior anti-MM therapies'}, {'measure': 'Time from Diagnosis and Line of Elranatamab Treatment', 'timeFrame': 'From the index date (initiation of elranatamab treatment) up to 18 months', 'description': 'Time from MM diagnosis to elranatamab initiation.'}, {'measure': 'Elranatamab Discontinuation and Treatment Modifications', 'timeFrame': 'From the index date (initiation of elranatamab treatment) up to 18 months', 'description': 'Number and proportion of patients with treatment discontinuation (and reasons), dosing or schedule modifications (excluding step-up), and switches from QW to Q2W after 6 cycles.'}, {'measure': 'Subsequent Treatments After Progression', 'timeFrame': 'From the index date (initiation of elranatamab treatment) up to 18 months', 'description': 'Number and proportion of patients receiving subsequent treatments following first progression or discontinuation of elranatamab.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Refractory Multiple Myeloma (RRMM)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C1071049', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate:\n\n* What is the real-world effectiveness of elranatamab in patients with relapsed and/or refractory multiple myeloma (RRMM) in Taiwan?\n* What are the baseline and clinical characteristics of RRMM patients who have received eltanatamab in Taiwan?\n* What are the treatment patterns of RRMM patients receiving elranatamab in the real-world setting in Taiwan?', 'detailedDescription': 'This study is seeking participants who:\n\n* have relapsed or refractory multiple myeloma (RRMM),\n* have received at least four prior lines of therapy (including a PI, an IMiD, and an anti-CD38 antibody),\n* are 18 years or older.\n\nParticipants receive elranatamab according to the approved label in Taiwan and continue treatment until disease progression or discontinuation. The study will evaluate real-world effectiveness and describe patient characteristics and treatment patterns to better understand elranatamab use in routine care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will consist of RRMM patients who have initiated elranatamab in consistent with the local health authority approved product label', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Patients age ≥ 18 years at the initiation of elranatamab\n2. Patients who have received at least one dose of elranatamab in consistent with the approved label in Taiwan.\n3. Evidence of a personally signed and dated informed consent document (ICD) indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. The ICD waiver is acceptable for patient who was ceased before recruitment.\n\nExclusion criteria:\n\nPatients who participated in any prior clinical trials using elranatamab.'}, 'identificationModule': {'nctId': 'NCT07391761', 'briefTitle': 'A Real World Study of Elranatamab in Patients With RR Multiple Myeloma in Taiwan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multi-center Observational Study of the Effectiveness of Elranatamab in Patients With Relapsed and/or Refractory Multiple Myeloma in Taiwan', 'orgStudyIdInfo': {'id': 'C1071049'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elranatamab in Patients with Relapsed and/or Refractory Multiple Myeloma', 'description': 'Patients with Relapsed and/or Refractory Multiple Myeloma treated with Elranatamab', 'interventionNames': ['Drug: Non intervention']}], 'interventions': [{'name': 'Non intervention', 'type': 'DRUG', 'description': 'Non intervention', 'armGroupLabels': ['Elranatamab in Patients with Relapsed and/or Refractory Multiple Myeloma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40705', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Pfizer CT.gov Call Center', 'role': 'CONTACT', 'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}