[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Celgene\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":382},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,51,63,91,133,162,189,214,238,260,286,313,343,366],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100053442","phase-3-a-study-to-evaluate-mezigdomide-bortezomib-and-dexamethasone-mezivd-versus-pomalidomide-bortezomib-and-dexamethasone-pvd-in-participants-with-relapsed-or-refractory-multiple-myeloma-rrmm-100053442",false,"NCT05519085","A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)","A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-1","SUCCESSOR-1","Inclusion Criteria\n\n\\- Participant has documented diagnosis of MM and measurable disease, defined as any of the following:.\n\ni) M-protein ≥ 0.5 grams per deciliter (g\u002FdL) by serum protein electrophoresis (sPEP) or.\n\nii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).\n\niii) For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \\> 100 mg\u002FL (10 mg\u002FdL) involved light chain and an abnormal kappa\u002Flambda FLC ratio.\n\n* Participants received 1 to 3 prior lines of antimyeloma therapy.\n* Participants achieved minimal response \\[MR\\] or better to at least 1 prior antimyeloma therapy.\n\nExclusion Criteria\n\n\\- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.\n\ni) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded.\n\nii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded.\n\n* For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.\n* Participant has had prior treatment with mezigdomide or pomalidomide.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","ALL","18 Years",{"count":20,"type":21},810,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.",[27],"Relapsed or Refractory Multiple Myeloma",[29,30,31,32,33,34,35,36,37],"Multiple myeloma","RRMM","MeziVd","PVd","CC92480","pomalidomide","bortezomib","dexamethasone","mezigdomide","RECRUITING","2026-07-10",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":42},"2022-09-20",{"date":46,"type":21},"2033-11-30",{"name":48,"class":49},"Celgene","INDUSTRY",266,{"id":52,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":25,"conditions":55,"keywords":56,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":61,"leadSponsor":62,"locationsCount":50},"100479138",{"count":20,"type":21},[24],[27],[29,30,31,32,33,34,35,36,37],"2026-07-01",{"date":59,"type":42},"2026-07-02",{"date":44,"type":42},{"date":46,"type":21},{"name":48,"class":49},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100367421","phase-3-a-study-to-evaluate-long-term-safety-in-participants-who-have-participated-in-other-luspatercept-ace-536-clinical-trials-100367421","NCT04064060","A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials","A Phase 3b, Open-label, Single-arm, Rollover Study to Evaluate Long-term Safety in Subjects Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be enrolled in this study:\n\n1. Participant is ≥ 18 years at the time of signing the informed consent form (ICF).\n2. Participant is willing and able to adhere to the study visit schedule and other protocol requirements.\n3. Participant has been participating in a luspatercept trial and continues to fulfill all the requirements of the parent protocol and the participant has been either:\n\n   1. Assigned to luspatercept treatment, continues to receive clinical benefit in the opinion of the investigator and should continue to receive luspatercept treatment, OR\n   2. Assigned to placebo arm in the parent protocol (at the time of unblinding or in follow-up) and should cross over to luspatercept treatment, OR\n   3. Assigned to the Follow-up Phase of the parent protocol, previously treated with luspatercept or placebo in the parent protocol who shall continue into LTPTFU phase in the rollover study until the follow-up commitments are met (unless requirements are met as per parent protocol to crossover to luspatercept treatment).\n4. Participant understands and voluntarily signs an informed consent document prior to any study-related assessments or procedures being conducted.\n5. Participant demonstrates compliance, as assessed by the investigator, with the parent study protocol requirements.\n6. Applies to on treatment Participants only- females of childbearing potential (FCBP) defined as a sexually mature woman who:\n\n1\\) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy or amenorrhea due to other medical reasons does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) must:\n\n1. Have two negative pregnancy tests as verified by the investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the participant practices true abstinence from heterosexual contact.\n2. Agrees to use, and be able to comply with highly effective, contraception without interruption, 35 days prior to starting investigational product (IP), during the study therapy (including dose interruptions), and for 84 days after discontinuation of study therapy.\n\n   7\\. Applies to on treatment participants only- Male participants must:\n\na. Agrees to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 84 days following investigational product discontinuation even if he has undergone a successful vasectomy.\n\nExclusion Criteria:\n\nThe presence of any of the following will exclude a participant from enrollment:\n\n1. Applies to on treatment participants only- Concomitant use of any medications\u002Fprocedures that are prohibited in the parent luspatercept protocol.\n2. Participant has met one or more criteria for study discontinuation as stipulated in the parent luspatercept protocol.\n3. Applies to on treatment participants only- More than 26 days between last luspatercept dose in the parent protocol and first dose into ACE-536-LTFU-001 protocol unless dose delay or dose discontinuation criteria met.\n4. Applies to on treatment participants only- Pregnant or breastfeeding females.\n5. Participant has any significant medical condition, laboratory abnormality, psychiatric illness, or is considered vulnerable by local regulations (eg, imprisoned or institutionalized) that would prevent the subject from participating in the study.\n6. Participant has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study.\n7. Participant has any condition that confounds the ability to interpret data from the study.",{"count":71,"type":21},665,[24],"A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants:\n\n* Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept\n* Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met\n* The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase\n* Transition Phase is defined as one Enrollment visit\n* Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. This does not apply to participants that are in long-term follow-up from the parent protocol\n* Follow-up Phase includes:\n\n  \\- 42 Day Safety Follow-up Visit\n* During the Safety Follow up, the participants will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting\n\n  \\- Long-term Post-treatment Follow-up (LTPTFU) Phase\n* Participants will be followed for overall survival every 6 months for at least 5 years from first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later, or until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Participants will also be monitored for progression to AML or any malignancies\u002Fpre-malignancies. New anticancer or disease related therapies should be collected at the same time schedule\n\nParticipants transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study.\n\nThe ACE-536-LTFU-001 rollover study will be terminated, and relevant participants will discontinue from the study when all participants fulfill 5 years on the study, including treatment and follow-up.",[75,76,77],"Myelodysplastic Syndromes (MDS)","Beta-thalassemia","Myeloproliferative Neoplasm(MPN)-Associated Myelofibrosis",[79,80,81,76,82],"ACE-536","Luspatercept","MDS","Myeloproliferative neoplasm (MPN)-associated myelofibrosis","2026-06-30",{"date":57,"type":42},{"date":86,"type":42},"2019-08-12",{"date":88,"type":21},"2028-05-12",{"name":48,"class":49},143,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":99,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},"100574838","phase-3-a-study-to-compare-the-efficacy-and-safety-of-bms-986365-versus-the-investigators-choice-of-therapy-in-participants-with-metastatic-castration-resistant-prostate-cancer-100574838","NCT06764485","A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer","A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge","rechARge","Inclusion Criteria\n\n* Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features.\n* Participants must have current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and\u002For soft tissue lesions on computed tomography\u002Fmagnetic resonance imaging (CT\u002FMRI).\n* Participants must be asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory - Short Form (BPI-SF) that must be \\\u003C 4.\n* Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).\n\nExclusion Criteria\n\n* Participants must not have impaired cardiac function or clinically significant cardiac disease.\n* Participants must not have any brain metastasis.\n* Participants must not have any liver metastasis.\n* Participants with superscan on technetium-99m (Tc-99m) radionuclide bone scans.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","MALE",{"count":101,"type":21},960,[24],"The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the investigator's choice of therapy in participants with Metastatic Castration-resistant Prostate Cancer.",[105],"Metastatic Castration-resistant Prostate Cancer",[107,108,109,110,111,112,113,114,115,116,117,118,119,120,97,121,122,123],"Prostate cancer","Protein degrader","Protein degradation","Androgen receptor","Castrate resistant prostate cancer","Castration resistant prostate cancer","Hormone resistant","Metastatic hormone resistant prostate cancer","Metastatic castrate resistant prostate cancer","Metastatic castration resistant prostate cancer","BMS-986365","CC-94676","CA071-1000","CA0711000","Abiraterone","Docetaxel","Enzalutamide","2026-06-25",{"date":126,"type":42},"2026-06-26",{"date":128,"type":42},"2025-03-13",{"date":130,"type":21},"2029-01-19",{"name":48,"class":49},282,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},"100576222","phase-2-a-study-to-evaluate-the-efficacy-safety-and-tolerability-of-bms-986368-in-participants-with-multiple-sclerosis-spasticity-100576222","NCT06782490","A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity","A Phase 2, Randomized, Double-Blind, Four-Arm, Placebo-Controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of Three Doses of Orally Administered BMS-986368, a FAAH\u002FMAGL Inhibitor, for the Treatment of Spasticity in Participants With Multiple Sclerosis (BALANCE-MSS-1)","MSS","Inclusion Criteria\n\n* Participants must have a multiple sclerosis (MS) diagnosis.\n* Participants must have a history of spasticity due to MS for at least 6 months prior to Visit 1.\n* Participants must have a Modified Ashworth Scale (mAS) score ≥2 in each of 2 muscle groups (at least one muscle group in the leg, excluding ankle plantar flexors) at Visit 1.\n* Participants must have an Expanded Disability Status Scale (EDSS) score 3.0-6.5 at Visit 1.\n\nExclusion Criteria\n\n* Participants must not have any concomitant disease or disorder that has symptoms of spasticity or that may influence the participant's level of spasticity.\n* Participants must not have an acute MS exacerbation\u002Frelapse requiring treatment or alteration in disease modifying drug dose within 3 months of Visit 1 or Visit 2.\n* Participants must not have a history of any substance abuse disorder as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Diagnostic Criteria for Drug and Alcohol Abuse.\n* Participants must not be currently taking a medication for spasticity that cannot be discontinued and washed out by Visit 2.\n* Participants must not have used FAAH\u002FMAGL inhibitor medication or any cannabinoid-related products (including cannabis, cannabidiol (CBD), or tetrahydrocannabinol (THC)) within 30 days prior to Visit 1.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","70 Years",{"count":143,"type":21},200,[145],"PHASE2","The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity",[148],"Multiple Sclerosis Spasticity",[150,151,152],"Spasticity","Multiple Sclerosis","BMS-986368","2026-06-05",{"date":155,"type":42},"2026-06-08",{"date":157,"type":42},"2025-06-05",{"date":159,"type":21},"2027-06-09",{"name":48,"class":49},54,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},"100430358","phase-1-study-of-safety-and-efficacy-of-iberdomide-cc-220-and-cc-99282-combined-with-r-chop-to-treat-lymphoma-100430358","NCT04884035","Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma","A Phase 1b, Open Label, Global, Multicenter, Dose Determination, Randomized Dose Expansion Study to Determine the Maximum Tolerated Dose, Assess the Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of Iberdomide (CC-220) in Combination With R-CHOP-21 and CC-99282 in Combination With R-CHOP-21 for Subjects With Previously Untreated Aggressive B-cell Lymphoma","Inclusion Criteria:\n\n* Participants must satisfy the following criteria to be enrolled in the study:\n\n  1. Is ≥ 18 years of age at the time of signing the informed consent form (ICF).\n  2. Participant has histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated, a-BCL according to 2016 WHO classification.\n  3. Participant has International Prognostic Index (IPI) score 0-5 in Part 1 and IPI 2-5 in Part 2. For the CELMoD and polatuzumab-R-CHP cohort, the subject must also have IPI score 0 to 5 in Part 2A and IPI 2 to 5 in Part 2B.\n  4. Participants must have measurable disease defined by at least one FDG-avid lesion for FDG-avid subtype and one bi-dimensionally measurable (\\> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification (Cheson, 2014).\n  5. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n  6. Participants must have the following laboratory values:\n\n     1. Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL or ≥ 1.0 x 109\u002FL in case of documented bone marrow involvement (\\> 50% or tumor cells), without growth factor support for 7 days (14 days if peg-G-CSF)\n     2. Hemoglobin (Hb) ≥ 8 g\u002FdL\n     3. Platelets (PLT) ≥ 75 x 109\u002FL or ≥ 50 x 109\u002FL in case of documented bone marrow involvement (\\>50% or tumor cells), without transfusion for 7 days\n     4. Aspartate aminotransferase \u002F serum glutamic oxaloacetic transaminase (AST\u002FSGOT) and alanine aminotransferase \u002F serum glutamate pyruvic transaminase (ALT\u002FSGPT) ≤ 2.5 x upper limit of normal (ULN). In the case of documented liver involvement by lymphoma, ALT\u002FSGPT and AST\u002FSGOT must be ≤ 5.0 x ULN.\n     5. Serum total bilirubin ≤ 2.0 mg\u002FdL except in cases of Gilbert's syndrome, then ≤ 5.0 mg\u002Fdl. Subjects receiving polatuzumab vedotin must have serum total bilirubin \\\u003C 1.5 × ULN (26 μmol\u002FL) (corresponding to mild degree as per National Cancer Institute Organ Dysfunction Working Group \\[NCI ODWG\\] criteria) except in cases of Gilbert's syndrome, then ≤ 3.0 mg\u002Fdl (51 μmol\u002FL).\n     6. Estimated serum creatinine clearance (CrCl) of ≥ 50 mL\u002Fmin using the modification of diet in renal disease (MDRD) formula.\n  7. All participants must:\n\n     1. Have an understanding that the study drug could have a potential teratogenic risk.\n     2. Agree to follow all requirements defined in the Pregnancy Prevention Program for CC-220 or CC-99282 Pregnancy Prevention Plan for Participants in Clinical trials.\n  8. Females of childbearing potential (FCBP) must:\n\n     a. Have two negative pregnancy tests as verified by the investigator prior to starting study therapy.\n  9. Male participants must:\n\n     1. Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study.\n\nExclusion Criteria:\n\n* The presence of any of the following will exclude a participant from enrollment:\n\n  1. Any significant medical condition, active infection (including SARS-CoV-2 suspected or confirmed), laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.\n  2. Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he\u002Fshe were to participate in the study.\n  3. Any other subtype of lymphoma.\n  4. Documented or suspected CNS involvement by lymphoma.\n  5. Persistent diarrhea or malabsorption ≥ Grade 2 (NCI CTCAE v5.0), despite medical management.\n  6. Peripheral neuropathy ≥ Grade 2 (NCI CTCAE v5.0).\n  7. Subjects with a history of progressive multifocal leukoencephalopathy.\n  8. Chronic systemic immunosuppressive therapy or corticosteroids\n  9. Impaired cardiac function or clinically significant cardiac disease, including any of the following:\n\n     a. Left ventricular ejection fraction (LVEF) \\\u003C 45% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO)\n  10. Major surgery ≤ 2 weeks prior to starting CC-220 or CC-99282; participant must have recovered from any clinically significant effects of recent surgery.\n  11. Any condition causing inability to swallow tablets.\n  12. Known seropositivity for or active viral infection with human immunodeficiency virus (HIV)\n  13. Known chronic active hepatitis B (hepatitis B virus surface antigen \\[HBsAg\\] positive and\u002For hepatitis B core antibody \\[anti-HBc\\] positive with viral DNA positive) or C (positive serology requiring treatment and\u002For with evidence of liver damage) infection\n  14. History of other malignancy, unless being free of the disease for ≥ 3 years; exceptions to the ≥ 3-year time limit include history of the following:\n\n      1. Localized nonmelanoma skin cancer\n      2. Carcinoma in situ of the cervix\n      3. Carcinoma in situ of the breast\n      4. Incidental histologic finding of prostate cancer (T1a or T1b as per Tumor Node Metastasis \\[TNM\\] staging system) or prostate cancer that has been treated with curative intent.\n  15. Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients of rituximab or polatuzumab vedotin.\n  16. Known hypersensitivity to any component of CHOP\u002FCHP regimen.\n  17. Known allergy to thalidomide, pomalidomide, or lenalidomide.",{"count":170,"type":21},224,[172],"PHASE1","This is a Phase 1b study consisting of 2 parts: a dose escalation (Part 1) of CC-220 or CC-99282 added to the standard R-CHOP-21 regimen for first-line treatment of a-BCL. The dose escalation (Part 1) will consist of 2 parallel arms in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP-21); CC-220 and R-CHOP-21 or CC-99282 and R-CHOP-21. Part 1 will be followed by a randomized dose expansion (Part 2) with CC-220 and\u002For CC-99282 at the Recommended Phase 2 Dose (RP2D) in combination with R-CHOP-21. A polatuzumab-R-CHP regimen in combination with CC-220 or CC-99282 will be explored with the addition of a new cohort only after the RP2D for the CC-220 and\u002For CC-99282 and R-CHOP-21 combination has been defined.",[175],"Lymphoma, B-Cell",[177,178,179,180,181],"Iberdomide","CC-220","CC-99282","Phase 1","B-Cell Lymphoma",{"date":155,"type":42},{"date":184,"type":42},"2021-09-15",{"date":186,"type":21},"2028-12-01",{"name":48,"class":49},43,{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":196,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},"100578260","phase-2-study-to-evaluate-the-efficacy-safety-and-tolerability-of-bms-986368-for-the-treatment-of-agitation-in-participants-with-alzheimers-disease-100578260","NCT06808984","Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease","A Phase 2, Randomized, Double-blind, Three-Arm, Placebo-controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of Orally Administered BMS-986368, a FAAH\u002FMAGL Inhibitor, for the Treatment of Agitation in Participants With Alzheimer's Disease (BALANCE-AAD-1)","Inclusion Criteria\n\n* Participants with a diagnosis of Alzheimer's disease with biomarker confirmation meeting the 2024 Revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup.\n* The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) definition of agitation.\n* History of agitation with onset at least four weeks prior to Screening.\n* MMSE-1 score ≤24.\n* NPI-NH agitation\u002Faggression sub-score ≥ 4.\n* Stable living environment for at least 6 weeks prior to Screening. Participants are eligible if they are in nursing homes, assisted living facilities, or living at home and have an identified study partner (caregiver).\n* Capable of self-locomotion (alone or with the aid of an assistive device); wheelchairs and other mobility aids are acceptable.\n\nExclusion Criteria\n\n* Clinically significant delusions\u002Fhallucinations requiring hospitalization.\n* History of bipolar disorder, schizophrenia, or schizoaffective disorder.\n* History of major depressive episode with psychotic features during the 12 months prior to Screening.\n* History of delirium within 30 days of Screening.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","55 Years","90 Years",{"count":199,"type":21},120,[145],"This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH\u002FMAGL inhibitor, for the treatment of agitation in participants with Alzheimer's Disease.",[203,204],"Agitation","Alzheimer Disease","2026-06-01",{"date":207,"type":42},"2026-06-02",{"date":209,"type":42},"2025-06-09",{"date":211,"type":21},"2028-01-07",{"name":48,"class":49},53,{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":223,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":237},"100319210","phase-2-long-term-follow-up-protocol-for-participants-treated-with-gene-modified-t-cells-100319210","NCT03435796","Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells","Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells","Inclusion Criteria:\n\n* Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored, Juno Therapeutics, other affiliates of BMS, or Celgene alliance partner-sponsored trial, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.\n* Must understand and voluntarily sign an Informed Consent Form\u002FInformed Assent Form prior to any study-related assessments\u002Fprocedures being conducted.\n\nExclusion Criteria:\n\nNot Applicable\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply",{"count":222,"type":21},1541,[145,24],"This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.\n\nParticipants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.",[226],"Neoplasms",[228,229,230],"Long-term follow up","Gene-Modified T Cells","CAR T Cell",{"date":207,"type":42},{"date":233,"type":42},"2018-07-19",{"date":235,"type":21},"2036-11-30",{"name":48,"class":49},205,{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":259},"100592058","phase-1-a-study-to-determine-the-recommended-dose-and-schedule-and-evaluate-the-safety-and-preliminary-efficacy-of-mezigdomide-in-combination-with-elranatamab-in-participants-with-relapsed-andor-refractory-multiple-myeloma-100592058","NCT06988488","A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and\u002For Refractory Multiple Myeloma","A Phase 1b\u002F2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and\u002For Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Age ≥18 with history of relapsed and refractory multiple myeloma (RRMM) treated with 2 to 4 prior lines of anti-myeloma therapy (Phase 1) or 1 to 3 prior lines of anti-myeloma therapy (Phase 2).\n* Measurable MM by local laboratory.\n* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.\n* Adherence to contraception requirements.\n\nExclusion Criteria:\n\n* Prior treatment with mezigdomide.\n* Prior treatment with T cell engaging or T cell engager (TCE).\n* Prior treatment with B cell-maturation antigen (BCMA)-targeting therapy, with the exception of participants who have received autologous BCMA-targeted CART-cell therapy\\> 6 months from the start of study therapy\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":246,"type":21},62,[172,145],"The purpose of this study is to evaluate the preliminary safety and determine the RP2D of mezigdomide in combination with elranatamab in participants with relapsed and refractory multiple myeloma (RRMM).",[250],"Multiple Myeloma","2026-05-26",{"date":253,"type":42},"2026-05-28",{"date":255,"type":42},"2025-10-07",{"date":257,"type":21},"2027-06-03",{"name":48,"class":49},22,{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":270,"conditions":271,"keywords":273,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":285},"100586140","phase-3-a-study-to-compare-the-efficacy-and-safety-of-golcadomide-in-combination-with-rituximab-golca--r-vs-investigators-choice-in-participants-with-relapsedrefractory-follicular-lymphoma-who-have-received-at-least-1-prior-line-of-systemic-therapy-golseek-4-100586140","NCT06911502","A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Choice in Participants With Relapsed\u002FRefractory Follicular Lymphoma Who Have Received at Least 1 Prior Line of Systemic Therapy (GOLSEEK-4)","A Phase 3, Multicenter, Randomized, Open Label Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) Vs Investigator's Choice in Participants With Relapsed\u002FRefractory Follicular Lymphoma Who Have Received at Least 1 Prior Line of Systemic Therapy","Inclusion Criteria:\n\n\\- Participant has histologically confirmed FL (Grade 1, 2, 3a or classic FL) as assessed by local pathology. Adequate fresh tumor biopsy tissue or archived tumor biopsy from the latest relapse if available with corresponding pathology report for retrospective central pathology confirmation of relapse, is required. Evaluation from fine needle aspirate is not permitted.\n\n\\- Relapsed or refractory disease: i) Relapsed FL is defined as relapse after an initial response of CR or PR to the most recent prior therapy.\n\nii) Refractory FL is defined as best response of SD or PD or a response that lasted less than 6 months to the most recent prior therapy.\n\n* Eastern Cooperative Oncology Group (ECOG) 0-2 (ECOG 3 authorized if it is due to lymphoma and not comorbidities).\n* Participant must have positron emission tomography (PET)-positive disease with at least one PET-positive lesion and measurable disease on cross section imaging by CT, as defined by Lugano classification.\n* Participants with an indication for anti-lymphoma treatment as per investigator assessment based on modified Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria.\n* Participant has received at least 1 or more prior lines of systemic therapy with one line consisting of a combination including an anti-CD20 monoclonal antibody (eg, rituximab, obinutuzumab) and an alkylating agent (eg, cyclophosphamide, bendamustine). Prior treatment with radiation therapy does not count as a line of therapy for eligibility.\n* Lab parameters:\n\n  i) Absolute neutrophil count (ANC) ≥ 1,000 cells\u002Fmm3 (1.0 x 109 \u002FL), ii) PLT count ≥ 75,000 cells\u002Fmm3 (75 x 109 \u002FL) iii) Hb ≥ 7.5 g\u002FdL\n* estimated glomerular filtration rate (eGFR) ≥ 30 ml\u002Fmin\u002F1.73m².\n* Serum aspartate transaminase (AST\u002FSGOT) or alanine transaminase (ALT\u002FSGPT) ≤ 2.5 x upper limit of normal (ULN). In case of documented liver involvement by lymphoma, ALT\u002FSGPT and AST\u002FSGOT must be ≤ 5.0× ULN.\n* Serum total bilirubin ≤ 1.5 × ULN (corresponding to mild dysfunction as per National Cancer Institute Organ Dysfunction Working Group \\[NCI ODWG\\] criteria). In case of documented liver involvement by lymphoma, serum total bilirubin must be ≤ 3.0 × ULN (corresponding to moderate dysfunction as per NCI ODWG criteria). For cases of Gilberts syndrome, serum total bilirubin≤ 5.0 × ULN.\n* Adequate cardiac function for participants receiving anthracycline-based chemotherapy, defined as left ventricular ejection fraction (LVEF) ≥ 45% as assessed by echocardiogram (ECHO) as standard of care or multi-gated acquisition scan (MUGA).\n\nExclusion Criteria:\n\n* Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL or of transformed Non-Hodgkin Lymphoma (NHL), including history of prior large B-cell lymphomas (LBCL), or any other indolent lymphoma.\n* Follicular large cell as per 5th World Health Organization (WHO) sub-classification (grade 3b FL per WHO 4th classification) or duodenal-type FL.\n* Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from compliantly participating in the study based on Investigator's judgment.\n* Participant has any condition that confounds the ability to interpret data from the study based on Investigator's or Sponsor's judgment.\n* Presence or history of central nervous system (CNS) involvement by lymphoma.\n* History of stroke or intracranial hemorrhage within 6 months prior to enrollment.\n* Deep venous thrombosis\u002FPulmonary embolism within 1 month prior to enrollment.\n* Participants with a history of progressive multifocal leukoencephalopathy.\n* Participant has any other subtype of lymphoma.\n* Participant has persistent diarrhea or malabsorption ≥ Grade 2 (NCI CTCAE v5.0), despite medical management.\n* History of another primary malignancy that has not been in remission for ≥ 3 years except for non-invasive malignancies.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":268,"type":21},400,[24],"The study is designed as a multicenter, randomized, open label Phase 3 study to compare the efficacy and safety of golcadomide in combination with rituximab vs investigator's choice in participants with relapsed\u002Frefractory follicular lymphoma who have received at least one line of prior systemic therapy.",[272],"Follicular Lymphoma",[272,274,275,276],"Second Line Follicular Lymphoma","Third Line Follicular Lymphoma","Relapsed\u002Frefractory follicular lymphoma","2026-05-18",{"date":279,"type":42},"2026-05-20",{"date":281,"type":42},"2025-07-28",{"date":283,"type":21},"2030-07-31",{"name":48,"class":49},160,{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":17,"minAge":293,"maxAge":294,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":297,"briefSummary":298,"conditions":299,"keywords":301,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":312},"100373538","phase-2-study-of-safety--pk-of-luspatercept-ace-536-in-pediatric-participants-with-beta--thalassemia-100373538","NCT04143724","Study of Safety & PK of Luspatercept (ACE-536) in Pediatric Participants With Beta (β)-Thalassemia","A Phase 2a Study to Evaluate the Safety and Pharmacokinetics of Luspatercept (ACE-536) in Pediatric Participants With Beta (β)-Thalassemia","Inclusion Criteria\n\n* Participants must be 6 years to \\\u003C 18 years of age at the time of signing the informed consent form (ICF)\u002Finformed assent form (IAF).\n* Participants (and when applicable, parent\u002Flegal representative) must understand and voluntarily sign an ICF\u002FIAF prior to conducting any study-related assessments\u002Fprocedures.\n* Participants (and when applicable, parent\u002Flegal representative) is willing and able to adhere to the study visit schedule and other protocol requirements.\n* Participants must have documented diagnosis of β-thalassemia or Hemoglobin E\u002Fβ-thalassemia.\n* Transfusion dependence (TD):\n\n  a. TD participant i. Participant is regularly transfused, defined as: ≥ 4 RBC transfusion events in the 24 weeks prior to enrollment with no transfusion-free period ≥ 42 days during that period.\n\nNote: For the purpose of the study, transfusions administered over 2 or 3 consecutive days are considered as part of a single transfusion event. Participant must have a history of regular transfusions for at least 2 years.\n\nb. NTD participant (ex-US sites only) i. Participant must have received \\\u003C 4 RBC transfusion events in the 24 weeks prior to enrollment.\n\nii. Participant must not be on a regular transfusion program and must be RBC transfusion-free for at least 8 weeks prior to enrollment.\n\niii. Participant must have mean baseline hemoglobin ≤ 10 g\u002FdL, based on a minimum of 2 measurements ≥ 1 week apart within 4 weeks prior to enrollment; hemoglobin values within 21 days post- transfusion will be excluded.\n\n* Participants have Karnofsky (age ≥16 years) or Lansky (age \\\u003C 16 years) performance status score ≥ 50 at screening.\n* Female children of childbearing potential (FCCBP), individuals of childbearing potential (IOCBP), and male (as assigned at birth) participants that have reached puberty (and when applicable, parent\u002Flegal representative) must agree to undergo physician-approved reproductive education and discuss the side effects of the study therapy on reproduction.\n* Female children of childbearing potential, defined as females who have achieved menarche and\u002For breast development in Tanner Stage 2 or greater and have not undergone a hysterectomy or bilateral oophorectomy and individuals of childbearing potential (IOCBP) defined as a sexually mature woman who has achieved menarche at some point, has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) must meet the following conditions below (Note: Secondary amenorrhea from any cause does not rule out childbearing potential):\n* Medically supervised serum pregnancy tests with a sensitivity of at least 25 mIU\u002FmL must be conducted in Female children of childbearing potential (FCCBP)\u002F individuals of childbearing potential (IOCBP), including those who commit to complete abstinence. Female children of childbearing potential\u002F individuals of childbearing potential (IOCBP) must have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy (one of these tests should be performed by central laboratory). Female children of childbearing potential\u002F individuals of childbearing potential (IOCBP) must agree to ongoing pregnancy testing during the course of the study at the End of Treatment (EOT) visit and at the 9-week Safety Follow-up visit.\n* Female participants must, as appropriate to age and at the discretion of the site Investigator, either commit to true abstinence\\* from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective\\*\\* contraception without interruption, 28 days prior to starting IP, during the study therapy (including dose interruptions), and for 12 weeks (approximately 5 times the mean terminal t1\u002F2 of luspatercept based on multiple-dose PK data) after discontinuation of study therapy.\n* Male (as assigned at birth) participants, as appropriate to age and the discretion of the study physician:\n\n  * Must practice true abstinence\\* (which must be reviewed on a monthly basis) or agree to use a synthetic or latex condom during sexual contact with a pregnant female or a Female children of childbearing potential (FCCBP)\u002F IOCBP while participating in the study, during dose interruptions and for at least 12 weeks (approximately 5 times the mean terminal t1\u002F2 of luspatercept based on multiple-dose PK data) following IP discontinuation, even if he has undergone a successful vasectomy.\n\n    * True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the participant. \\[Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\\] \\*\\* Agreement to use highly effective methods of contraception that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly throughout the course of the study. Such methods include: Combined (estrogen and progesterone\u002Fprogestin containing) hormonal contraception: Oral; Intravaginal; Transdermal; Progestogen\u002Fprogestin only hormonal contraception associated with inhibition of ovulation: Oral; Injectable hormonal contraception; Implantable hormonal contraception; Placement of an intrauterine device (IUD); Placement of an intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomized partner; Sexual Abstinence.\n\nExclusion Criteria\n\n* Participant has a diagnosis of Hemoglobin S\u002Fβ-thalassemia or alpha (α)-thalassemia (eg, Hemoglobin H); β-thalassemia combined with α-thalassemia is allowed.\n* Participant has of active hepatitis C (HCV) infection, as demonstrated by a positive HCF-ribonucleic acid (RNS) test of sufficient sensitivity, or active infectious hepatitis B (as demonstrated by the presence of hepatitis B surface antigen (HBsAG) and\u002For hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) positive, or known positive human immunodeficiency virus (HIV).\n\nNote: Participants receiving antiviral therapies should have 2 negative HCV-RNA tests 3 months apart before ICF\u002FIAF signature, ie, one test at the end of the antiviral therapy and the second test 3 months following the first test.\n\n* Participant has deep vein thrombosis (DVT), stroke, or other thromboembolic event(s) (except clogged indwelling catheter) requiring medical intervention ≤ 24 weeks prior to enrollment.\n* Participant has platelet count \\> 1000 x 109\u002FL.\n* Participant has treatment with another investigational drug or device ≤ 28 days prior to enrollment.\n* Participant has prior exposure to sotatercept (ACE-011) or luspatercept (ACE-536).\n* Participant underwent or is scheduled for HSCT or gene therapy.\n* Participant use of iron chelation therapy (ICT), if initiated ≤ 8 weeks prior to enrollment (allowed if initiated \\> 8 weeks before or during treatment).\n* Participant received treatment with hydroxyurea immunomodulatory drugs IMiDs (such as thalidomide), other fetal Hb (HbF) inducers or erythropoiesis-stimulating agents (ESAs) ≤ 12 weeks prior to enrollment for NTD participants and ≤ 24 weeks for TD participants.\n* Participant is pregnant or breastfeeding female or plan to get pregnant during the study.\n* Participant has uncontrolled hypertension. Controlled hypertension for this protocol is considered: blood pressure value corresponding to ≤ Grade 1 according to NCI CTCAE version 5.0 with or without pharmacological treatment.\n* Participant has major organ damage, including:\n\n  1. Symptomatic splenomegaly\n  2. Liver disease with alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\> 3X the upper limit of normal (ULN) for age\n  3. Heart disease, heart failure as classified by the New York Heart Association (NYHA) classification 3 or higher, or significant arrhythmia requiring treatment, or recent myocardial infarction within 6 months of enrollment\n  4. Lung disease, including pulmonary fibrosis or pulmonary hypertension of Grade ≥ 3 according to NCI-CTCAE version 5.0.\n  5. Renal insufficiency defined as:\n* A serum creatinine based on age\u002Fgender based on threshold derived from Schwartz formula for estimating GFR utilizing child length and stature data published by the Centers for Disease Control.\n* Participant has proteinuria ≥ Grade 3 according to NCI CTCAE version 5.0 (which is equivalent to a urine protein\u002Fcreatinine ratio \\> 215 mg\u002Fmmol of creatinine), or a urine albumin\u002Fcreatinine ratio \\> 129 mg\u002Fmmol of creatinine.\n* Participant use of high dose long-term therapy with systemic glucocorticoids ≤ 12 weeks prior to enrollment (physiologic replacement therapy for adrenal insufficiency is allowed). Low-dose long-term (defined as ≤ 0.2 mg\u002Fkg\u002Fday or ≤ 10 mg\u002Fday of prednisone equivalent), short treatment (eg, for prevention or treatment of transfusion reactions) inhaled, intranasal and topical corticosteroids are allowed.\n* Participant has history of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the IP (refer to the IB).\n* Participant use of cytotoxic agents, immunosuppressants ≤ 28 days prior to enrollment (ie, antithymocite globulin (ATG) or cyclosporine).\n* Participant has history of malignancy with the exception of:\n\n  1. Curatively resected nonmelanoma skin cancer.\n  2. Curatively treated carcinoma in situ.\n  3. Other solid tumor with no known active disease in the opinion of the Investigator.\n* Participant who has extramedullary hematopoiesis (EMH) complications or requires treatment to control the growth of EMH masse(s) during the screening period.\n* Participants with any medical or psychiatric condition that in the opinion of the investigator would put the participant at unacceptable risk of participating in the study or may impact interpretation of the study results.\n* Participants who use herbs or food supplements (eg: Chinese traditional medicine), if, per investigator's judgment, likely to impact the safety and efficacy assessment, for 24 weeks before initiating the study treatment for TD participants, and 12 weeks for NTD participants.","6 Years","17 Years",{"count":296,"type":21},99,[145],"This is a Phase 2a study to evaluate the safety and pharmacokinetics (PK) of luspatercept in pediatric participants with β-thalassemia.\n\nThe study will be conducted in 2 parts for both transfusion-dependent (TD) and non-transfusion-dependent (NTD) β-thalassemia participants: TD Part A will be in adolescent participants aged 12 to \\\u003C18 years with two dose escalation cohorts, followed by a dose expansion cohorts. NTD Part A will be conducted in the same age group participants as TD Part A with dose confirmation and expansion cohorts. After Part A TD participants have completed at least one year of treatment, all available safety data from Part A adolescent participants will be evaluated before initiating TD and NTD Part B in the age group from 6 to \\\u003C12 years old. Part B will consist of two dose escalation cohorts for TD and two dose escalation cohorts for NTD.\n\nUpon completion of the Treatment Period, participants of any cohort who are benefiting from the study treatment, will be offered the opportunity to continue luspatercept treatment in the Long-term Treatment Period for up to 5 years from their first dose.\n\nParticipants who discontinue study treatment at any time will continue in the Posttreatment Follow-up Period for at least 5 years from their first dose of luspatercept, or 3 years from their last dose, whichever occurs later, or until they withdraw consent\u002Fassent, are lost to follow-up, or the End of Trial, whichever occurs first.",[300],"Beta-Thalassemia",[79,80,302,300,303],"Pharmacokinetics","Red Blood Cell Transfusion","2026-01-02",{"date":306,"type":42},"2026-01-06",{"date":308,"type":42},"2019-11-07",{"date":310,"type":21},"2035-06-11",{"name":48,"class":49},26,{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":320,"sex":99,"minAge":18,"maxAge":321,"enrollmentInfo":322,"targetDuration":4,"studyType":22,"phases":324,"briefSummary":325,"conditions":326,"keywords":328,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":342},"100611607","phase-1-a-study-to-evaluate-the-effect-of-itraconazole-and-rifampin-on-the-drug-levels-of-ar-ldd-bms-986365-in-healthy-adult-male-participants-100611607","NCT07242781","A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult Male Participants","A Phase 1, Open-label, 2-part, Fixed-sequence, Crossover Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Pharmacokinetics of AR-LDD (BMS-986365) in Healthy Adult Male Participants","Inclusion Criteria\n\n* Participants must be male, at the time of signing the Informed Consent Form (ICF), have a Body Mass Index (BMI) of 18.0 to 32.0 kg\u002Fm2; and healthy as determined by medical history, PE, vital signs, 12-lead ECG, transthoracic echocardiogram (TTE) and clinical laboratory assessments.\n\nExclusion Criteria\n\n* Participants must not have any significant or chronic illness.\n* Participants must not have a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QT interval.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",true,"60 Years",{"count":323,"type":21},42,[172],"The purpose of this study is to evaluate the effect of Itraconazole and Rifampin on the drug levels of AR-LDD (BMS-986365) in healthy adult male participants.",[327],"Healthy Volunteers",[329,117,118,330,331,302,332,333],"Healthy male volunteers","Itraconazole","Rifampin","Crossover","Open-label","2025-12-18",{"date":336,"type":42},"2025-12-24",{"date":338,"type":42},"2025-12-15",{"date":340,"type":21},"2026-06-14",{"name":48,"class":49},1,{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":350,"phases":4,"briefSummary":351,"conditions":352,"keywords":353,"overallStatus":361,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":365,"locationsCount":4},"100421690","expanded-access-protocol-eap-for-participants-receiving-idecabtagene-vicleucel-that-is-nonconforming-for-commercial-release-100421690","NCT04771078","Expanded Access Protocol (EAP) for Participants Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release","Expanded Access Protocol (EAP) for Patients Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release","Inclusion Criteria:\n\n* Had a participant-specific batch of Idecabtagene vicleucel (ide-cel) manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria\n* Remanufacturing is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the participant\n* Clinically stable\n\nExclusion Criteria:\n\n* Has a hypersensitivity to the active substance or to any of the excipients\n* No experience of a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of Adverse Events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming Idecabtagene vicleucel (ide-cel)\n* Has any condition and\u002For laboratory abnormality that places the participant at unacceptable risk if he\u002Fshe were to participate in the Expanded Access Protocol based on the Investigator's judgement\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply","EXPANDED_ACCESS","This study is designed to evaluate the safety and efficacy of nonconforming idecabtagene vicleucel (ide-cel) in participants with multiple myeloma per the approved prescribing information. This is an expanded access protocol (EAP) to be conducted at Risk Evaluation and Mitigation Strategies (REMS) qualified sites approved for commercial administration of idecabtagene vicleucel and where the EAP is authorized to be conducted for use of nonconforming idecabtagene vicleucel.\n\nNon-conforming idecabtagene vicluecel is idecabtagene vicleucel that does not meet commercial release specifications but may be acceptable for use as an investigational product in the Expanded Access Protocol setting.",[250],[354,250,355,356,357,358,359,360],"BB2121","Expanded Access","idecabtagene vicleucel","nonconforming","CAR T","EAP","Pre-Approval Access","AVAILABLE","2025-12-04",{"date":364,"type":42},"2025-12-12",{"name":48,"class":49},{"id":367,"slug":368,"hasResults":11,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":350,"phases":4,"briefSummary":373,"conditions":374,"keywords":376,"overallStatus":361,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":381,"locationsCount":342},"100341252","individual-patient-compassionate-use-of-fedratinib-100341252","NCT03723148","Individual Patient Compassionate Use of Fedratinib","Compassionate Use of Fedratinib for Patients Who Have Previously Received TG101348, SAR302503 or Fedratinib","Inclusion Criteria:\n\nSubjects will be considered if they received TG101348, SAR302503 or Fedratinib as a participant on a clinical trial prior to 31 Jan 2018.\n\nExclusion Criteria:\n\nSubject is eligible for enrollment in an ongoing clinical trial using Fedratinib or has been treated with Fedratinib after 31 Jan 2018.","This is an expanded access program (EAP) for eligible participants designed to provide access to fedratinib.\n\nExpanded access is only available in markets where fedratinib is not yet approved.",[375],"Myelofibrosis",[355,377],"Compassionate Use","2020-09-17",{"date":380,"type":42},"2020-09-18",{"name":48,"class":49},""]