[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467158":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":37,"centralContacts":41,"locations":42,"responsibleParty":63,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":41,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":41,"enrollmentInfo":78,"targetDuration":41,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":41,"overallStatus":44,"whyStopped":41,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"City of Hope Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (daratumumab, 225Ac\u002F111In-DOTA-daratumumab)","EXPERIMENTAL","Patients receive daratumumab IV over 45 minutes. Two hours later, patients receive 111In-DOTA-daratumumab and 225Ac-DOTA-daratumumab IV over 20-30 minutes.",[13,14,15],"Biological: Actinium Ac 225-DOTA-Daratumumab","Biological: Daratumumab","Biological: Indium In 111-DOTA-Daratumumab",[17,24,32],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"BIOLOGICAL","Actinium Ac 225-DOTA-Daratumumab","Given IV",[9],[23],"225Ac-DOTA-Daratumumab; [225Ac]-DOTA-Daratumumab",{"type":18,"name":25,"description":20,"armGroupLabels":26,"otherNames":27},"Daratumumab",[9],[28,29,30,31],"Anti-CD38 Monoclonal Antibody","Darzalex","HuMax-CD38","JNJ-54767414",{"type":18,"name":33,"description":20,"armGroupLabels":34,"otherNames":35},"Indium In 111-DOTA-Daratumumab",[9],[36],"111In-DOTA-Daratumumab; [111In]-DOTA-Daratumumab",[38],{"name":39,"affiliation":5,"role":40},"Scott R Goldsmith","PRINCIPAL_INVESTIGATOR",null,[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Duarte","California","91010","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-117.97729,34.13945,{"lat":54,"lon":53},[57,62],{"name":58,"role":59,"phone":60,"phoneExt":41,"email":61},"Scott R. Goldsmith","CONTACT","626-218-3562","sgoldsmith@coh.org",{"name":58,"role":40,"phone":41,"phoneExt":41,"email":41},{"type":64,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[66],{"name":67,"class":68},"National Cancer Institute (NCI)","NIH","100467158","phase-1-radioimmunotherapy-111indium225actinium-dota-daratumumab-for-the-treatment-of-relapsedrefractory-multiple-myeloma-100467158",false,"NCT05363111","Radioimmunotherapy (111Indium\u002F225Actinium-DOTA-daratumumab) for the Treatment of Relapsed\u002FRefractory Multiple Myeloma","Phase 1 Trial of 111Indium\u002F225Actinium-DOTA-Daratumumab in Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Age \\>= 18 years\n* Karnofsky performance status (KPS) \\> 60%\n* Multiple myeloma according to International Myeloma Working Group (IMWG) criteria with measurable disease defined as one of the following:\n\n  * Serum monoclonal protein \\>= 1.0 g\u002FdL (or 0.5 g\u002FdL in patients with immunoglobulin A \\[IgA\\] multiple myeloma \\[MM\\])\n  * 24 hour urine monoclonal protein \\>= 200 mg\u002F24 hour\n  * Serum free light chain (FLC) of \\> 10 mg\u002FdL and an abnormal kappa:lambda ratio\n* Minimum of two prior lines of therapy\n* Previously received treatment with all of the following: a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Refractory (defined per IMWG Consensus Criteria) to daratumumab\n* CD38 expression on multiple myeloma (MM) cells from bone marrow aspirate or biopsy as demonstrated by flow cytometry or immunohistochemistry\n* Refractory (defined per IMWG Consensus Criteria) or intolerant to most recent therapy\n* Fully recovered from the acute toxic effects (except alopecia) to =\\\u003C grade 1 to prior anti-cancer therapy\n* Prior antitumor therapy must have been completed prior to enrollment as follows:\n\n  * \\>= 21 days for investigational agents, cytotoxic chemotherapy\n  * \\>= 21 days for radiation therapy. Note: Patients must have measurable disease that has been untreated\u002Funaffected by local radiation therapy\n  * \\>= 3 months for prior anti-CD38-targeted therapy, adoptive cell therapy\n  * \\>=14 days for proteasome inhibitor therapy\n  * \\>= 7 days for immunomodulatory agents\n* Absolute neutrophil count (ANC) \\>= 1,000\u002Fmm\\^3 (within 14 days prior to day 1 of protocol therapy)\n\n  * NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Platelets \\>= 75,000\u002Fmm\\^3 (\\>= 50,000\u002Fmm\\^3 if \\>= 50% marrow involvement) (within 14 days prior to day 1 of protocol therapy)\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease) (within 14 days prior to day 1 of protocol therapy)\n* Aspartate aminotransferase (AST) =\\\u003C 3 x ULN (within 14 days prior to day 1 of protocol therapy)\n* Alanine aminotransferase (ALT) =\\\u003C 3 x ULN (within 14 days prior to day 1 of protocol therapy)\n* Creatinine =\\\u003C 1.5 mg\u002Fdl AND\u002FOR creatinine clearance of \\>= 40 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula (within 14 days prior to day 1 of protocol therapy)\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (within 14 days prior to day 1 of protocol therapy)\n* Woman of childbearing potential must be practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods; condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository; male partner sterilization; true abstinence (when this is in line with the preferred and usual lifestyle of the subject) during and after the study (6 months after the last dose of 225Ac-DOTA-Daratumumab for women).\n\nA man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control, e.g., either condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository or partner with occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug\n\n* Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Daratumumab or other anti CD38 antibody treatment \\\u003C 3 months prior to study enrollment\n* Prior radiopharmaceutical therapy\n* Detectable antibodies directed against daratumumab\n* Subject has received previous radiation to \\> 25% of their bone marrow\n* Female patients who are lactating or have a positive pregnancy test during the screening period\n* Major surgery within 14 days prior to start of study treatment\n* Subject is receiving concurrent chemotherapy, radiation, or biologic for cancer treatment. Subject is receiving bone marrow stimulatory factors (e.g., granulocyte-macrophage colony-stimulating factor \\[GM-CSF\\]). Note: Hormonal therapy for someone with a history of cancer treated with curative intent is permitted if subject has been on hormonal therapy \\> 1 year\n* Vaccination with live attenuated vaccines within 4 weeks of study agent administration\n* A diagnosis of primary amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia, or POEMS\n* Severe persistent asthma (forced expiratory volume in 1 second \\[FEV1\\] \\\u003C 60% and\u002For daily symptoms) or severe chronic obstructive pulmonary disease (COPD) defined clinically or by historical pulmonary function tests with an FEV1 \\\u003C 50% predicted\n* Subject has known allergies, hypersensitivity, or intolerance to monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or investigator's brochure). Patients with a history of infusion reactions to daratumumab with prior treatment that resolved with supportive measures and in whom daratumumab therapy was not previously discontinued because of infusion reactions are permitted\n* Subject has uncontrolled human immunodeficiency virus (HIV-1), chronic or active hepatitis B, or active hepatitis A or C\n\n  * Patients with HIV are eligible unless their CD4+ T-cell counts are \\\u003C 350 cells\u002FmcL or they have a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective antiretroviral therapy (ART) according to Department of Health and Human Services (DHHS) treatment guidelines is recommended\n* Subject has any one of the following:\n\n  * Clinically significant abnormal electrocardiogram (ECG) finding at screening\n  * Congestive heart failure (New York Heart Association class III or IV)\n  * Myocardial infarction within 12 months prior to starting study treatment\n  * Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris\n* Subject has presence of other active malignancy \\[see exceptions below\\] (However, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible). The following malignancies are exceptions to the active malignancy statement:\n\n  * Basal cell carcinoma of the skin\n  * Squamous cell carcinoma of the skin\n  * Non-muscle invasive bladder cancer\n  * Carcinoma in situ of the cervix\n  * Carcinoma in situ of the breast\n  * Incidental histologic finding of prostate cancer (T1a or T1b using the TNM clinical staging system) or prostate cancer that is curative\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","ALL","18 Years",{"count":79,"type":80},15,"ESTIMATED","INTERVENTIONAL",[83],"PHASE1","This phase I trial tests the safety, side effects, and best dose of actinium Ac 225-DOTA-daratumumab (225Ac-DOTA-daratumumab) in combination with daratumumab and indium In 111-DOTA-daratumumab (111In-DOTA-daratumumab) in treating patients with multiple myeloma that does not respond to treatment (refractory) or that has come back (recurrent). Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. 111In-DOTA-daratumumab and 225Ac-DOTA-daratumumab are forms of radioimmunotherapy in which a monoclonal antibody, daratumumab, has been linked to a radiotracer to allow for targeted delivery of the treatment to cancer cells. Giving all three together may kill more cancer cells.",[86,87],"Recurrent Plasma Cell Myeloma","Refractory Plasma Cell Myeloma","2025-10-27",{"date":90,"type":91},"2025-10-29","ACTUAL",{"date":93,"type":91},"2022-11-22",{"date":95,"type":80},"2027-03-23",{"name":5,"class":6},1]