Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2026-01-16 @ 1:31 AM
Study NCT ID:
NCT05495620
Status:
UNKNOWN
Last Update Posted:
2022-08-10
First Post:
2022-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term KRd in Relapsed and/or 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C524865', 'term': 'carfilzomib'}, {'id': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-08', 'studyFirstSubmitDate': '2022-07-05', 'studyFirstSubmitQcDate': '2022-08-08', 'lastUpdatePostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'up to 54 months', 'description': 'the time from the first date of KRd to the date of disease progression or death or censored date'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'up to 54 months', 'description': 'the time from the first date of KRd treatment to the time of death or censored date'}, {'measure': 'Overall response rate, clinical benefit rate', 'timeFrame': 'up to 54 months', 'description': 'the proportion of patients who achieved a PR or better, which response is defined by the IMWG criteria, the proportion of patients who achieved a MR or better'}, {'measure': 'Duration of response', 'timeFrame': 'up to 54 months', 'description': 'the time from the first date of response to the time of disease progression or death or censored date'}, {'measure': 'Toxicity profile', 'timeFrame': 'up to 2 years', 'description': 'toxicities as determined by the incidence of clinical and laboratory findings occurred from the time of the first date of KRd treatment to the date of disease progression or death or censored date'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma in Relapse', 'Multiple Myeloma, Refractory']}, 'referencesModule': {'references': [{'pmid': '25482145', 'type': 'BACKGROUND', 'citation': 'Stewart AK, Rajkumar SV, Dimopoulos MA, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel DS, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak AJ, San-Miguel JF, Ludwig H, Wang M, Maisnar V, Minarik J, Bensinger WI, Mateos MV, Ben-Yehuda D, Kukreti V, Zojwalla N, Tonda ME, Yang X, Xing B, Moreau P, Palumbo A; ASPIRE Investigators. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015 Jan 8;372(2):142-52. doi: 10.1056/NEJMoa1411321. Epub 2014 Dec 6.'}]}, 'descriptionModule': {'briefSummary': 'Research question: Is KRd therapy effective and safe in the real-world Asian patients?\n\nPrimay objective: To evaluate the effectiveness of KRd in RRMM patients\n\nSecondary objectives:\n\nTo evaluate the effectiveness of investigational treatment strategy by\n\n* PFS difference according to the high-risk disease subgroups and previous treatment\n* OS\n* Overall response rate and clinical benefit rate\n* Duration of response To evaluate the safety and tolerability of KRd in RRMM patients', 'detailedDescription': 'Key study variables:\n\nDemographic data, ISS, R-ISS, cytogenetic abnormalities on FISH and G-banding, previous treatment regimens, response to previous treatment regimens, existence of extramedullary plasmacytoma, MM-related symptoms, whether or not M protein has increased twice or more in 2-3 months at the time of KRd commencement, response to KRd therapy, duration of KRd treatment, adverse events during KRd therapy, disease progression and progression date, survival, and censored date or day of death'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Relapsed and/or refractory multiple myeloma patients treated with carfilzomib-lenalidomide-dexamethasone combination chemotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Patients ≥ 19 years\n2. Relapsed and/or refractory multiple myeloma patients\n3. Patients who had received KRd combination chemotherapy from February, 2018 to February, 2020.\n\nExclusion criteria\n\n1. Patient who had not been treated with KRd combination therapy from the first cycle of treatment\n2. Patients who had received KRd combination chemotherapy before February, 2018 and after February, 2020.'}, 'identificationModule': {'nctId': 'NCT05495620', 'briefTitle': 'Long-term KRd in Relapsed and/or Refractory Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Dong-A University Hospital'}, 'officialTitle': 'Real-world Evidence of Carfilzomib, Lenalidomide, Dexamethasone Combination Therapy in Korean Relapsed and/or Refractory Multiple Myeloma Patients', 'orgStudyIdInfo': {'id': 'DAUHIRB-22-081'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Relapsed and/or refractory multiple myeloma', 'description': 'Multiple myeloma in relapsed but not refractory, relapsed and refractory, and primary refractory status', 'interventionNames': ['Drug: Carfilzomib', 'Drug: Lenalidomide', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Carfilzomib', 'type': 'DRUG', 'otherNames': ['Kyprolis'], 'description': 'Intravenous\n\ncarfilzomib, lenalidomide, dexamethasone', 'armGroupLabels': ['Relapsed and/or refractory multiple myeloma']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'otherNames': ['Revlimid'], 'description': 'Oral', 'armGroupLabels': ['Relapsed and/or refractory multiple myeloma']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Oral or intravenous', 'armGroupLabels': ['Relapsed and/or refractory multiple myeloma']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ji Hyun Lee, MD, Ph.D', 'role': 'CONTACT', 'email': 'hidrleejh@dau.ac.kr', 'phone': '82-51-240-2915'}], 'overallOfficials': [{'name': 'Sung-Hyun Kim, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dong-A University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sung-Hyun Kim', 'investigatorAffiliation': 'Dong-A University Hospital'}}}}