[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527025":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":30,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":30,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":39,"whyStopped":30,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Augusta University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dara-CyBorD","EXPERIMENTAL","Induction treatment with daratumumab-hyaluronidase (dara SC) in combination with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) for four cycles of 28 days, followed by restaging with repeat PET-CT, bone marrow evaluation, and myeloma serological testing.",[13],"Combination Product: Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"COMBINATION_PRODUCT","Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone","This intervention is Daratumumab-hyaluronidase in combination with the chemotherapy regimen \"CyBord\" (cyclophosphamide, bortezomib, and dexamethasone) and then with lenalidomide maintenance in patients with newly diagnosed multiple myeloma who have new onset renal failure.",[9],[21],"DaraCyBord",[23],{"name":24,"affiliation":5,"role":25},"Amany RA Keruakous, MD","PRINCIPAL_INVESTIGATOR",[27,32],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","706-721-2505",null,"AKERUAKOUS@augusta.edu",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"James T Sonnenberg, BS","9106192597","jsonnenberg@augusta.edu",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Georgia Cancer Center-Augusta University","RECRUITING","Augusta","Georgia","30912","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-81.97484,33.47097,{"lat":49,"lon":48},[52,54,55,56],{"name":24,"role":28,"phone":53,"phoneExt":30,"email":31},"7067212505",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},{"name":24,"role":25,"phone":30,"phoneExt":30,"email":30},{"name":57,"role":58,"phone":30,"phoneExt":30,"email":30},"Amber B. Clemmons, PharmD","SUB_INVESTIGATOR",{"type":60,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[62],{"name":63,"class":64},"Janssen Scientific Affairs, LLC","INDUSTRY","100527025","early-phase-1-pilot-study-dara-cybord-in-newly-diagnosed-multiple-myeloma-patients-with-renal-failure-100527025",false,"NCT06142396","Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure","Pilot Study of Daratumumab in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-CyBorD) in Newly Diagnosed Multiple Myeloma Patients With Renal Failure","Inclusion Criteria:\n\n1. Patients must have had a confirmed new diagnosis of MM following revised IMWG criteria.\n2. Patients must have Zubrod\u002FECOG Performance Status ≤ 2.\n3. Patients must have renal insufficiency. Renal insufficiency is defined as eCrCl \\\u003C 60 mL\u002Fmin (using Cockcroft-Gault Equation for Cr Cl) and\u002For necessitating dialysis\n4. must not have known allergies to any of the study drugs. Must have adequate organ function.\n5. International normalized ratio (INR) and prothrombin time (PT) ≤1.5 × ULN. Activated partial thromboplastin time (aPTT) ≤1.5 × ULN.\n\nExclusion Criteria:\n\n* 1\\. Known seropositive for: human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.\n\n  2\\. Known Chronic obstructive pulmonary disease (COPD). 3. Known Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification.\n\n  4\\. Known Clinically significant heart disease is defined as: myocardial infarction within 6 months before enrollment, or unstable or uncontrolled disease\u002Fcondition related to or affection cardiac function.\n\n  5\\. Women who are pregnant, breastfeeding, or planning to become pregnant while enrolled in this study.\n\n  6\\. Patients with grade 3 or 4 peripheral neuropathy 7. Patients with other active malignancies that require concurrent treatment 8. Known CNS involvement or plasma cell leukemia, or AL amyloidosis 9. Participants with active infection requiring systemic therapy 10. Has known substance abuse disorders that would interfere with cooperation with the requirements of the study.","ALL","18 Years","80 Years",{"count":76,"type":77},30,"ESTIMATED","INTERVENTIONAL",[80],"EARLY_PHASE1","The goal of this study is to assess the efficacy of induction treatment with daratumumab-hyaluronidase (dara SC) with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) for four cycles in patients with newly diagnosed multiple myeloma who have new onset renal failure. This study will also investigate the difference responses in African American (AA) patients versus non-African American patients.\n\nThe primary questions this study aims to answer are:\n\n1. To evaluate the very good partial response rate (VGPR) after 4 cycles of Dara-CyBord.\n2. To evaluate the renal response rate (RRR) after 4 cycles of Dara-CyBord.",[83,84],"Multiple Myeloma","Renal Failure",[86,87,88,89],"Daratumumab","Bortezomib","Cyclophosphamide","Dexamethasone","2026-03-11",{"date":92,"type":93},"2026-03-12","ACTUAL",{"date":95,"type":93},"2024-11-01",{"date":97,"type":77},"2027-11-01",{"name":5,"class":6},1]