[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pmd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pmd":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":20,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100622370","phase-2-a-phase-2-study-of-radiotherapy-induced-immune-priming-to-enhance-elranatamab-elra-in-relapsed-refractory-multiple-myeloma-rrmm-with-extramedullary-disease-emd-and-paramedullary-disease-pmd-prime-emd-pmd-100622370",false,"NCT07382739","A Phase 2 Study of Radiotherapy-induced Immune Priming to Enhance Elranatamab (Elra) in Relapsed Refractory Multiple Myeloma (RRMM) With Extramedullary Disease (EMD) and Paramedullary Disease (PMD) \"PRIME-EMD-PMD\"","Inclusion Criteria\n\n* RRMM exposed to IMID, PI, anti-CD38 mAb, relapsed or refractory to at least one prior line of therapy (LOT), progressed on or after the last regimen:\n\n  1. Relapsed disease: progressive disease (PD) \\>60 days after cessation of prior therapy\n  2. Refractory disease: PD \\\u003C=60 days after cessation of prior therapy, \\\u003C25% reduction in paraprotein (monoclonal protein \\[M-protein\\] or serum free light chains \\[sFLC\\]) or measurements of EMD\u002FPMD\n* Diagnosis of relapsed or refractory multiple myeloma as indicated by progression by IMWG criteria\n* At least one locus of EMD or PMD present on imaging (either PET\u002FCT or magnetic resonance imaging \\[MRI\\]):\n* EMD: extramedullary plasmacytoma, not a contiguous extension from a bone lesion.\n* PMD: paraskeletal plasmacytoma, contiguous extension from a bone lesion At least one locus of EMD\u002FPMD that was not previously radiated and can be treated with radiation\n* Hematology (supportive care is allowed, including transfusions and granulocyte colony stimulating factor (G-CSF), if cytopenia is deemed secondary to myeloma disease burden):\n* Hemoglobin (Hgb) \\>=7g\u002FdL\n* Platelet\\>=50K\u002FuL\n* Absolute neutrophil count (ANC) \\>=0.75K\u002FuL\n* Chemistry:\n* Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) \\\u003C=2.5 x upper\n* limit of normal (ULN)\n* Total bilirubin (TBili) \\\u003C=1.5ULN (except for a known history of Gilbert syndrome)\n* Creatinine clearance (CrCL) \\>=30mL\u002Fmin\u002F1.73m2\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) \\\u003C=2, unless ECOG PS due to pain\u002Fmorbidity secondary to underlying myeloma disease, with the potential of improved ECOG PS to \\\u003C=2.\n* All participants must be either\n* Not of childbearing potential, or\n* Practicing at least 1 highly effective method of contraception until 6 months after the last dose of study treatment.\n* Childbearing age female participantsmust have a negative serum pregnancy test at screening and must agree to further pregnancy tests during the study.\n\nExclusion Criteria\n\n1. Prior or concurrent exposure to any of the following in the specified time frame prior to the first dose of Elra treatment:\n\n   * Within 14 days or at least 5 half-lives, whichever is less, of any investigational treatment\n   * Within 7 days of IMIDs, PI, anti-CD38 mAb, or cytotoxic systemic myeloma therapies\n   * Within 12 weeks of autologous stem-cell therapy (ASCT) or 6 months of AlloSCT and has to be off immunosuppressive agents \\>=42 days without signs of graft versus host disease (GVHD)\n   * Within 2 weeks of major surgery\n   * Within 6 months of cerebrovascular accident (CVA) events\n2. Waldenstrom, POEMS, Amyloidosis, ongoing plasma cell leukemia (PCL)\n3. History of Human Immunodeficiency Virus (HIV)\n4. Active, uncontrolled HBV infection despite antiviral therapy.\n5. Uncontrolled cardiac, pulmonary, gastrointestinal (GI), hepatic, renal, central nervous system(CNS) diseases not due to myeloma, at the discretion of investigator, that are not a candidate for T cell engager (TCE) therapy\n6. Uncontrolled or recurrent infections\n7. Autoimmune disease requiring systemic treatment (except for low dose steroids, equivalent to 10mg\u002Fday or less of prednisone)\n8. Disabling psychiatric conditions, substance abuse (alcohol, or drug), dementia, altered mental status\n9. Any other active malignancies within 5 years of completing treatment (with the exception of hormonal therapies for breast or prostate cancer) and \\>minimal risk of recurrence\n10. Myelodysplastic syndromes (MDS)\n11. Any issues that may impair the ability of the participant to receive or tolerate the planned treatment, to understand the informed consent, or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that would prevent, limit, or confound the protocol specified assessments.\n12. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Elra or other agents used in study.\n13. History or possible non-compliance with recommended treatments","ALL",{"count":17,"type":18},34,"ESTIMATED","INTERVENTIONAL",[21],"PHASE2","To learn if low doses of radiation therapy can help the drug elranatamab enhance the killing effect of the cancer cells.",[24,25,26,27,28,29,30],"Phase 2","Radiotherapy-Induced Immune Priming","Elranatamab","Relapsed Refractory Multiple Myeloma (RRMM)","Extramedullary Disease in Multiple Myeloma","Paramedullary Disease","PMD","RECRUITING","2026-04-09",{"date":34,"type":35},"2026-04-14","ACTUAL",{"date":37,"type":35},"2026-03-31",{"date":39,"type":18},"2030-12-31",{"name":41,"class":42},"M.D. Anderson Cancer Center","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":123,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100289408","the-myelin-disorders-biorepository-project-100289408","NCT03047369","The Myelin Disorders Biorepository Project","The Myelin Disorders Biorepository Project and Global Leukodystrophy Initiative Clinical Trials Network","MDBP","Inclusion Criteria (Affected Subjects):\n\n* Male or female of any age;\n* Suspected or confirmed diagnosis of leukodystrophy or other disorder affecting the white matter of the brain based primarily on the finding of central nervous system neuroimaging consistent with this diagnosis or on an existing diagnosis of a leukodystrophy or genetic leukoencephalopathy as defined in existing classification systems, or in the presence of variant(s) of uncertain significance or genotype consistent with leukodytrophy;\n* Documentation of informed consent by the subject, parent, or legal guardian, and, if appropriate, documentation of assent;\n* Willingness to provide clinical data, participate in standardized assessments, and\u002For provide biologic samples.\n\nExclusion Criteria (Affected Subjects)\n\n* Established diagnosis at the time of referral that is not consistent with a genetic disorder of the white matter, such as an acquired demyelinating condition (e.g. multiple sclerosis), or an infectious etiology, with the exception of sequelae of congenital infections such as CMV;\n* Inability to provide consent.\n\nInclusion Criteria (Healthy Controls)\n\n* Male or female of any age;\n* Individuals with no confirmed or suspected diagnosis of leukodystrophy or other disorder affecting the white matter of the brain (including affected patients' caregivers);\n* Documentation of informed consent by the subject, parent, or legal guardian, and, if appropriate, documentation of assent.\n\nExclusion Criteria (Healthy Controls)\n\n\\- Inability to provide consent.",{"count":53,"type":18},12000,"10 Years","OBSERVATIONAL","The Myelin Disorders Biorepository Project (MDBP) seeks to collect and analyze clinical data and biological samples from leukodystrophy patients worldwide to support ongoing and future research projects. The MDBP is one of the world's largest leukodystrophy biorepositories, having enrolled nearly 2,000 affected individuals since it was launched over a decade ago.\n\nResearchers working in the biorepository hope to use these materials to uncover new genetic etiologies for various leukodystrophies, develop biomarkers for use in future clinical trials, and better understand the natural history of these disorders. The knowledge gained from these efforts may help improve the diagnostic tools and treatment options available to patients in the future.",[58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,30,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122],"Leukodystrophy","White Matter Disease","Leukoencephalopathies","4H Syndrome","Adrenoleukodystrophy","AMN","ALD","ALD Gene Mutation","ALD (Adrenoleukodystrophy)","X-linked Adrenoleukodystrophy","X-ALD","Adrenomyeloneuropathy","Aicardi Goutieres Syndrome","AGS","Alexander Disease","Alexanders Leukodystrophy","AxD","ADLD","Canavan Disease","CTX","Cerebrotendinous Xanthomatoses","Krabbe Disease","GALC Deficiency","Globoid Leukodystrophy","TUBB4A-Related Leukodystrophy","H-ABC - Hypomyelination, Atrophy of Basal Ganglia and Cerebellum","HBSL","HBSL - Hypomyelination, Brain Stem, Spinal Cord, Leg Spasticity","LBSL","Leukoencephalopathy With Brain Stem and Spinal Cord Involvement and High Lactate Syndrome (Disorder)","Leukoencephalopathy With Brainstem and Spinal Cord Involvement and Lactate Elevation","ALSP","CSF1R Gene Mutation","HCC - Hypomyelination and Congenital Cataract","MLC1","Megalencephalic Leukoencephalopathy With Subcortical Cysts","MLD","Metachromatic Leukodystrophy","Pelizaeus-Merzbacher Disease","PLP1 Null Syndrome","PLP1 Gene Duplication | Blood or Tissue | Mutations","Pelizaeus Merzbacher Like Disease","Peroxisomal Biogenesis Disorder","Zellweger Syndrome","Refsum Disease","Salla Disease","Sialic Storage Disease","Sjögren","Sjogren-Larsson Syndrome","Van Der Knapp Disease","Vanishing White Matter Disease","Charcot-Marie-Tooth","CMT","Mct8 (Slc16A2)-Specific Thyroid Hormone Cell Transporter Deficiency","Allan-Herndon-Dudley Syndrome","Cadasil","Cockayne Syndrome","Multiple Sulfatase Deficiency","Gangliosidoses","GM2 Gangliosidosis","BPAN","Labrune Syndrome","LCC","Mucopolysaccharidoses","TBCK-Related Intellectual Disability Syndrome",[124,125,126,127,128,129],"leukodystrophy","white matter disease","leukoencephalopathy","myelin","demyelinating","mdbp","2025-10-22",{"date":132,"type":35},"2025-10-23",{"date":134,"type":35},"2016-12-08",{"date":136,"type":18},"2030-12-08",{"name":138,"class":42},"Children's Hospital of Philadelphia",23]