[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07727668":3,"trial-entities:NCT07727668":288,"trial-summary:NCT07727668":291},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":49,"secondary_outcomes":54,"sex":99,"minimum_age":100,"maximum_age":101,"healthy_volunteers":102,"eligibility_criteria":103,"std_ages":156,"locations":159,"central_contacts":180,"overall_officials":188,"references":191,"see_also_links":284},"NCT07727668","Study-26-00586","Iberdomide (CC-220) Priming to Improve T Cell Fitness Prior to Leukapheresis for Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Relapsed\u002FRefractory Multiple Myeloma (RRMM)","Feasibility Study of Iberdomide (CC-220) Priming to Improve T Cell Fitness Prior to Leukapheresis for Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Relapsed\u002FRefractory Multiple Myeloma (RRMM)","NOT_YET_RECRUITING","2031-07","2026-07","2026-07-27","Shambavi Richard","OTHER",true,"This feasibility trial studies the efficacy of administering iberdomide (CC-220) as a priming agent prior to leukapheresis in patients with relapsed\u002Frefractory multiple myeloma (RRMM) who are already planned for standard-of-care CAR-T therapy. Giving iberdomide before CAR-T may improve T cell fitness which may improve CAR-T expansion kinetics and response after infusion.","In this feasibility study, patients with RRMM planned for standard of care CAR-T will be approached for consent for enrollment. Participating patients will receive one 28-day cycle of iberdomide at a dose of 1.0 mg daily, using a dosing schedule of 1.0 mg once daily for 21 days followed by 7 days off. After completion of the 28-day cycle, patients will proceed with leukapheresis on day 29 of therapy, with allowance for up to a 14-day delay in leukapheresis if needed. Blood samples will be collected on day 1 (prior to iberdomide exposure) and on the day of leukapheresis to compare T cell profiling before and after iberdomide priming. After leukapheresis, patients will proceed with standard of care management, including bridging therapy if indicated, until CAR-T infusion. After infusion, blood samples will be collected daily during initial hospitalization, then weekly for 1 month, and then monthly for up to 1 year. Blood samples will be evaluated for maximal CAR-T and ALC expansion and CAR-T persistence. Patients will be monitored per standard of care protocols for clinical efficacy and toxicity after CAR-T therapy for up to 1 year.",[18,19],"Multiple Myeloma","Relapsed\u002FRefractory Multiple Myeloma",[21,22,23,24,25],"Multiple myeloma","Relapsed\u002Frefractory multiple myeloma","Iberdomide","CAR-T therapy","CC-220","INTERVENTIONAL","TREATMENT",[29],"EARLY_PHASE1",{"count":31,"type":32},22,"ESTIMATED",[34,40,45],{"type":35,"name":23,"description":36,"armGroupLabels":37,"otherNames":39},"DRUG","1.0mg iberdomide capsules administered orally, daily on days 1-21 of a 28-day cycle",[38],"Patients with RRMM",[25],{"type":41,"name":42,"description":43,"armGroupLabels":44},"PROCEDURE","CAR-T Leukapheresis","A procedure in which blood is collected and white blood cells (including T cells) are separated and collected. The remaining blood components are returned to the participant. The collected T cells will be used to manufacture the CAR-T cell therapy.",[38],{"type":41,"name":46,"description":47,"armGroupLabels":48},"CAR-T Infusion","Participants will receive an intravenous infusion of standard-of-care CAR-T therapy manufactured from the participant's previously collected cells",[38],[50],{"measure":51,"description":52,"timeFrame":53},"Proportion of patients with T cell effector memory (TEM) expansion following iberdomide priming.","Proportion of patients with T cell effector memory (TEM) expansion following iberdomide priming, defined as an absolute increase of \\>10 percentage points or a relative increase of \\>50% in TEM cells.","On the day of leukapheresis, after completing iberdomide therapy on Day 29",[55,58,62,65,68,71,74,77,79,83,87,90,93,96],{"measure":56,"description":57,"timeFrame":53},"Change in Proportion of T cell subsets from baseline after iberdomide priming","Proportion of T cell subsets (including terminally differentiated effector, exhausted, and activated T cells) present for each participant in the feasibility evaluable (FE) population at leukapheresis (Priming D29 after iberdomide) to baseline (Priming-D1).",{"measure":59,"description":60,"timeFrame":61},"Cmax with iberdomide priming prior to leukapheresis","Cmax is the highest measured concentration of iberdomide. Cmax will be assessed in the CAR-T evaluable (CARTE) population","After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12",{"measure":63,"description":64,"timeFrame":61},"Tmax with iberdomide priming prior to leukapheresis,","Time to reach Cmax. Tmax will be assessed in CAR-T (CARTE) population",{"measure":66,"description":67,"timeFrame":61},"AUC0-14 with iberdomide priming prior to leukapheresis","Total Exposure over time. AUC0-14 will be assessed in the CAR-T evaluable (CARTE) population.",{"measure":69,"description":70,"timeFrame":61},"CAR-T persistence with iberdomide priming prior to leukapheresis,","CAR-T persistence will track therapy effectiveness over time. CAR-T persistence will be assessed in the CAR-T evaluable (CARTE) population.",{"measure":72,"description":73,"timeFrame":61},"ALCmax with iberdomide priming prior to leukapheresis","Absolute Lymphocyte Count (ALC) is a key blood test measuring the exact number of lymphocytes. ALCmax measures the maximum count overtime. ALCmax will be assessed in the CAR-T evaluable (CARTE) population.",{"measure":75,"description":76,"timeFrame":61},"Time to ALCmax with iberdomide priming prior to leukapheresis","Time to reach absolute lymphocyte count maximum (ALCmax) in the CAR-T evaluable (CARTE) population.",{"measure":78,"timeFrame":61},"Absolute lymphocyte count (ALC) expansion kinetics as a proxy for CAR-T expansion",{"measure":80,"description":81,"timeFrame":82},"Overall response rate","Overall response rate (ORR), defined as the proportion of patients that achieve at least a partial response according to IMWG criteria","After CAR-T at Day 100 (~Month 3) and Month 12",{"measure":84,"description":85,"timeFrame":86},"Measurable residual disease","Rate of measurable residual disease (MRD)-negativity and MRD-negative complete response (CR) as defined by IMWG response criteria","After CAR-T at Day 100 (~Month 3) and Month 12. Long-term follow-up for up to 5 years.",{"measure":88,"description":89,"timeFrame":86},"Progression-free survival","Progression-free survival (PFS), defined as the time from CAR-T infusion until progression by IMWG response criteria or death",{"measure":91,"description":92,"timeFrame":86},"Overall survival","Overall survival (OS), defined as the time from CAR-T infusion until death",{"measure":94,"description":95,"timeFrame":86},"Duration of response","Duration of response (DOR), defined as time from first observed response after CAR-T until progression by IMWG criteria",{"measure":97,"description":98,"timeFrame":86},"Time to next treatment","Time to next treatment (TTNT), defined as the time from CAR-T infusion until initiation of the next line of myeloma-directed therapy for subsequent relapsed disease","ALL","18 Years",null,false,{"inclusion":104,"exclusion":117,"raw_text":155},[105,106,107,108,109,110,111,112,113,114,115,116],"Subject is ≥18 years of age at the time of signing the informed consent form (ICF).","Subject must understand and voluntarily sign an ICF prior to any study-related assessments\u002Fprocedures being conducted.","Subject is willing and able to adhere to the study visit schedule and other protocol requirements.","All subjects must have documented diagnosis of MM and be eligible for commercial CAR-T therapy with either cilta-cel or ide-cel.","All subjects must have ≥2 prior lines of multiple myeloma directed therapy, as determined by their treating clinician","All patients must have ECOG Performance Status ≤ 2.","Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy tests (minimum sensitivity 25 IU\u002FL or equivalent units of hCG), at screening (10-14 days prior to start of study drug); another within 24 hours prior to the start of study drug.","Women must not be breastfeeding","WOCBP must agree to follow instructions for method(s) of contraception for 1 month (4 weeks) before the start of treatment with study drugs, for the duration of treatment with study drugs, and for a total of 1 month (4 weeks) after completion of iberdomide.","Males who are sexually active with WOCBP must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking Iberdomide (CC-220) and for up to 90 days after discontinuing Iberdomide (CC-220), even if they have undergone a successful vasectomy. Male patients must not donate sperm.","Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described in this section.","All subjects must agree not to share study medication.",[118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154],"Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis (no active multiple myeloma), Waldenström's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)","Subjects with active plasma cell leukemia (defined as either 20% of peripheral blood white blood cell count comprised of plasma\u002FCD138+ cells or an absolute plasma cell count of 2 x 109\u002FL)","Subjects with active Central Nervous System involvement with multiple myeloma","Subjects with active multiple myeloma that cannot be safely managed with single-agent iberdomide for the duration of the priming period, per the discretion of the treating physician or PI","Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form","Any serious concurrent medical conditions that may make the patient non-evaluable or put the patient's safety at risk, per the discretion of the treating physician or PI","Subjects with an active infection that requires parenteral anti-infective treatment within 7 days","Unable to tolerate thromboembolic prophylaxis while on iberdomide","Severe hypersensitivity reaction to prior IMiD (thalidomide, lenalidomide or pomalidomide)","Grade \\> 2 peripheral neuropathy (per NCI CTCAE v5.0)","Patients with a positive PCR test for hepatitis B virus or hepatitis C virus indicating active infection. Patients with positive serologic testing indicating exposure will need confirmatory testing by PCR.","Patients with detectable HIV viral load or known acquired immunodeficiency syndrome (AIDS).","Prior or concurrent malignancy, except for the following:","Adequately treated basal cell or squamous cell skin cancer or in-situ carcinoma.","Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured.","Localized prostate cancer (N0M0):","with a Gleason score of ≤6, treated within the last 24 months or untreated and under surveillance,","with a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence; or","any history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence per the discretion of the treating physician or PI","Non-invasive cervical cancer treated within the last 24 months that is considered completely cured.","Breast cancer: adequately treated lobular carcinoma in situ, or ductal carcinoma in situ, or history of localized breast cancer and receiving anti-hormonal agents and considered to have a very low risk of recurrence.","Any other cancer from which the subject has been disease free for \\> 3 years prior to study entry, or considered cured with minimal risk of disease recurrence.","Prior treatment with Iberdomide (CC-220) within 6 months prior to enrollment","Prior allogeneic stem cell transplant except subjects who have completed the stem cell transplant \\> 12 months prior to first dose of study drug, have no history of graft versus host disease, and are not on systemic immunosuppressive therapy","Major cardiac surgery within 8 weeks prior to the first dose of study drug; all other major surgery within 4 weeks prior to the first dose of study drug.","Subjects with following physical and laboratory test findings:","Absolute neutrophil count \\\u003C 1 x 109\u002FL without growth factor support within 1 week, or absolute neutrophil count \\\u003C 0.5 x 109\u002FL for patients with documented Duffy-null blood typing","Platelets \\\u003C 50 x 109\u002FL without transfusion support within 1 week","Creatinine clearance \\\u003C 30 ml\u002Fmin according to the Cockroft-Gault formula:","Female CrCl = \\[(140 - age in years) x weight in kg x 0.85\\] \u002F \\[72 x serum creatinine in mg\u002Fdl\\]","Male CrCl = \\[(140 - age in years) x weight in kg x 1.00\\] \u002F \\[72 x serum creatinine in mg\u002Fdl\\]","Total bilirubin ≥ 2 x ULN (≥ 3 x ULN if documented Gilbert's syndrome)","AST or ALT ≥ 3x ULN","Corrected serum calcium \\> 13.5 mg\u002FdL","Are also excluded:","Prisoners or subjects who are involuntarily incarcerated","Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness","INCLUSION CRITERIA\n\n* Subject is ≥18 years of age at the time of signing the informed consent form (ICF).\n* Subject must understand and voluntarily sign an ICF prior to any study-related assessments\u002Fprocedures being conducted.\n* Subject is willing and able to adhere to the study visit schedule and other protocol requirements.\n* All subjects must have documented diagnosis of MM and be eligible for commercial CAR-T therapy with either cilta-cel or ide-cel.\n* All subjects must have ≥2 prior lines of multiple myeloma directed therapy, as determined by their treating clinician\n* All patients must have ECOG Performance Status ≤ 2.\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy tests (minimum sensitivity 25 IU\u002FL or equivalent units of hCG), at screening (10-14 days prior to start of study drug); another within 24 hours prior to the start of study drug.\n* Women must not be breastfeeding\n* WOCBP must agree to follow instructions for method(s) of contraception for 1 month (4 weeks) before the start of treatment with study drugs, for the duration of treatment with study drugs, and for a total of 1 month (4 weeks) after completion of iberdomide.\n* Males who are sexually active with WOCBP must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking Iberdomide (CC-220) and for up to 90 days after discontinuing Iberdomide (CC-220), even if they have undergone a successful vasectomy. Male patients must not donate sperm.\n* Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described in this section.\n* All subjects must agree not to share study medication.\n\nEXCLUSION CRITERIA\n\n* Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis (no active multiple myeloma), Waldenström's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)\n* Subjects with active plasma cell leukemia (defined as either 20% of peripheral blood white blood cell count comprised of plasma\u002FCD138+ cells or an absolute plasma cell count of 2 x 109\u002FL)\n* Subjects with active Central Nervous System involvement with multiple myeloma\n* Subjects with active multiple myeloma that cannot be safely managed with single-agent iberdomide for the duration of the priming period, per the discretion of the treating physician or PI\n* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form\n* Any serious concurrent medical conditions that may make the patient non-evaluable or put the patient's safety at risk, per the discretion of the treating physician or PI\n* Subjects with an active infection that requires parenteral anti-infective treatment within 7 days\n* Unable to tolerate thromboembolic prophylaxis while on iberdomide\n* Severe hypersensitivity reaction to prior IMiD (thalidomide, lenalidomide or pomalidomide)\n* Grade \\> 2 peripheral neuropathy (per NCI CTCAE v5.0)\n* Patients with a positive PCR test for hepatitis B virus or hepatitis C virus indicating active infection. Patients with positive serologic testing indicating exposure will need confirmatory testing by PCR.\n* Patients with detectable HIV viral load or known acquired immunodeficiency syndrome (AIDS).\n* Prior or concurrent malignancy, except for the following:\n\n  * Adequately treated basal cell or squamous cell skin cancer or in-situ carcinoma.\n  * Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured.\n  * Localized prostate cancer (N0M0):\n  * with a Gleason score of ≤6, treated within the last 24 months or untreated and under surveillance,\n  * with a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence; or\n  * any history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence per the discretion of the treating physician or PI\n  * Non-invasive cervical cancer treated within the last 24 months that is considered completely cured.\n  * Breast cancer: adequately treated lobular carcinoma in situ, or ductal carcinoma in situ, or history of localized breast cancer and receiving anti-hormonal agents and considered to have a very low risk of recurrence.\n  * Any other cancer from which the subject has been disease free for \\> 3 years prior to study entry, or considered cured with minimal risk of disease recurrence.\n* Prior treatment with Iberdomide (CC-220) within 6 months prior to enrollment\n* Prior allogeneic stem cell transplant except subjects who have completed the stem cell transplant \\> 12 months prior to first dose of study drug, have no history of graft versus host disease, and are not on systemic immunosuppressive therapy\n* Major cardiac surgery within 8 weeks prior to the first dose of study drug; all other major surgery within 4 weeks prior to the first dose of study drug.\n* Subjects with following physical and laboratory test findings:\n\n  * Absolute neutrophil count \\\u003C 1 x 109\u002FL without growth factor support within 1 week, or absolute neutrophil count \\\u003C 0.5 x 109\u002FL for patients with documented Duffy-null blood typing\n  * Platelets \\\u003C 50 x 109\u002FL without transfusion support within 1 week\n  * Creatinine clearance \\\u003C 30 ml\u002Fmin according to the Cockroft-Gault formula:\n* Female CrCl = \\[(140 - age in years) x weight in kg x 0.85\\] \u002F \\[72 x serum creatinine in mg\u002Fdl\\]\n* Male CrCl = \\[(140 - age in years) x weight in kg x 1.00\\] \u002F \\[72 x serum creatinine in mg\u002Fdl\\]\n\n  * Total bilirubin ≥ 2 x ULN (≥ 3 x ULN if documented Gilbert's syndrome)\n  * AST or ALT ≥ 3x ULN\n  * Corrected serum calcium \\> 13.5 mg\u002FdL\n* Are also excluded:\n\n  * Prisoners or subjects who are involuntarily incarcerated\n  * Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness",[157,158],"ADULT","OLDER_ADULT",[160],{"facility":161,"city":162,"state":162,"zip":163,"country":164,"contacts":165,"geoPoint":177},"Icahn School of Medicine at Mount Sinai","New York","10029","United States",[166,171,175],{"name":167,"role":168,"phone":169,"email":170},"Vikram Madan","CONTACT","(646) 745-6092","Vikram.Madan@mssm.edu",{"name":172,"role":168,"phone":173,"email":174},"Rashmi Unawane","212-824-2385","Rashmi.Unawane@mssm.edu",{"name":12,"role":176},"PRINCIPAL_INVESTIGATOR",{"lat":178,"lon":179},40.71427,-74.00597,[181,185],{"name":182,"role":168,"phone":183,"email":184},"Vikram Madan, MPH","(347) 835-3446","vikram.madan@mssm.edu",{"name":172,"role":168,"phone":186,"email":187},"(212) 824-2385","rashmi.unawane@mssm.edu",[189],{"name":190,"affiliation":161,"role":176},"Shambavi Richard, MD",[192,196,199,202,205,208,211,214,217,220,223,226,229,232,235,238,241,244,247,250,253,256,259,262,266,269,272,275,278,281],{"pmid":193,"type":194,"citation":195},"30592986","BACKGROUND","Lee DW, Santomasso BD, Locke FL, Ghobadi A, Turtle CJ, Brudno JN, Maus MV, Park JH, Mead E, Pavletic S, Go WY, Eldjerou L, Gardner RA, Frey N, Curran KJ, Peggs K, Pasquini M, DiPersio JF, van den Brink MRM, Komanduri KV, Grupp SA, Neelapu SS. ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biol Blood Marrow Transplant. 2019 Apr;25(4):625-638. doi: 10.1016\u002Fj.bbmt.2018.12.758. Epub 2018 Dec 25.",{"pmid":197,"type":194,"citation":198},"27511158","Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, Munshi N, Lonial S, Blade J, Mateos MV, Dimopoulos M, Kastritis E, Boccadoro M, Orlowski R, Goldschmidt H, Spencer A, Hou J, Chng WJ, Usmani SZ, Zamagni E, Shimizu K, Jagannath S, Johnsen HE, Terpos E, Reiman A, Kyle RA, Sonneveld P, Richardson PG, McCarthy P, Ludwig H, Chen W, Cavo M, Harousseau JL, Lentzsch S, Hillengass J, Palumbo A, Orfao A, Rajkumar SV, Miguel JS, Avet-Loiseau H. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016 Aug;17(8):e328-e346. doi: 10.1016\u002FS1470-2045(16)30206-6.",{"pmid":200,"type":194,"citation":201},"28726797","Kumar SK, Rajkumar V, Kyle RA, van Duin M, Sonneveld P, Mateos MV, Gay F, Anderson KC. Multiple myeloma. Nat Rev Dis Primers. 2017 Jul 20;3:17046. doi: 10.1038\u002Fnrdp.2017.46.",{"pmid":203,"type":194,"citation":204},"38943315","Rajkumar SV. Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management. Am J Hematol. 2024 Sep;99(9):1802-1824. doi: 10.1002\u002Fajh.27422. Epub 2024 Jun 28.",{"pmid":206,"type":194,"citation":207},"32989217","Rajkumar SV, Kumar S. Multiple myeloma current treatment algorithms. Blood Cancer J. 2020 Sep 28;10(9):94. doi: 10.1038\u002Fs41408-020-00359-2.",{"pmid":209,"type":194,"citation":210},"31780814","D'Agostino M, Raje N. Anti-BCMA CAR T-cell therapy in multiple myeloma: can we do better? Leukemia. 2020 Jan;34(1):21-34. doi: 10.1038\u002Fs41375-019-0669-4. Epub 2019 Nov 28.",{"pmid":212,"type":194,"citation":213},"33024544","Kryukova EV, Vulfius CA, Ziganshin RH, Andreeva TV, Starkov VG, Tsetlin VI, Utkin YN. Snake C-type lectin-like proteins inhibit nicotinic acetylcholine receptors. J Venom Res. 2020 Jul 6;10:23-29. eCollection 2020.",{"pmid":215,"type":194,"citation":216},"26369987","Sommermeyer D, Hudecek M, Kosasih PL, Gogishvili T, Maloney DG, Turtle CJ, Riddell SR. Chimeric antigen receptor-modified T cells derived from defined CD8+ and CD4+ subsets confer superior antitumor reactivity in vivo. Leukemia. 2016 Feb;30(2):492-500. doi: 10.1038\u002Fleu.2015.247. Epub 2015 Sep 15.",{"pmid":218,"type":194,"citation":219},"30896447","Cohen AD, Garfall AL, Stadtmauer EA, Melenhorst JJ, Lacey SF, Lancaster E, Vogl DT, Weiss BM, Dengel K, Nelson A, Plesa G, Chen F, Davis MM, Hwang WT, Young RM, Brogdon JL, Isaacs R, Pruteanu-Malinici I, Siegel DL, Levine BL, June CH, Milone MC. B cell maturation antigen-specific CAR T cells are clinically active in multiple myeloma. J Clin Invest. 2019 Mar 21;129(6):2210-2221. doi: 10.1172\u002FJCI126397.",{"pmid":221,"type":194,"citation":222},"31407501","Okkabaz N, Turgut MA. Necrotising fasciitis of the thigh caused by duodenum invasion of renal cell carcinoma: A case report. Int Wound J. 2019 Oct;16(5):1195-1198. doi: 10.1111\u002Fiwj.13186. Epub 2019 Aug 12.",{"pmid":224,"type":194,"citation":225},"38184754","Fischer L, Grieb N, Born P, Weiss R, Seiffert S, Boldt A, Fricke S, Franz P, Heyn S, Kubasch AS, Baber R, Weidner H, Wang SY, Bach E, Hoffmann S, Ussmann J, Kirchberg J, Hell S, Schwind S, Metzeler KH, Herling M, Jentzsch M, Franke GN, Sack U, Reiche K, Kohl U, Platzbecker U, Vucinic V, Merz M. Cellular dynamics following CAR T cell therapy are associated with response and toxicity in relapsed\u002Frefractory myeloma. Leukemia. 2024 Feb;38(2):372-382. doi: 10.1038\u002Fs41375-023-02129-y. Epub 2024 Jan 6.",{"pmid":227,"type":194,"citation":228},"38263628","Doting EL, Jensen MB, Peter EK, Ellegaard-Jensen L, Tranter M, Benning LG, Hansen M, Anesio AM. The exometabolome of microbial communities inhabiting bare ice surfaces on the southern Greenland Ice Sheet. Environ Microbiol. 2024 Feb;26(2):e16574. doi: 10.1111\u002F1462-2920.16574. Epub 2024 Jan 23.",{"pmid":230,"type":194,"citation":231},"37592106","Lin Y, Raje NS, Berdeja JG, Siegel DS, Jagannath S, Madduri D, Liedtke M, Rosenblatt J, Maus MV, Massaro M, Petrocca F, Yeri A, Finney O, Caia A, Yang Z, Martin N, Campbell TB, Rytlewski J, Fuller J, Hege K, Munshi NC, Kochenderfer JN. Idecabtagene vicleucel for relapsed and refractory multiple myeloma: post hoc 18-month follow-up of a phase 1 trial. Nat Med. 2023 Sep;29(9):2286-2294. doi: 10.1038\u002Fs41591-023-02496-0. Epub 2023 Aug 17.",{"pmid":233,"type":194,"citation":234},"31042851","Tricarico PM, Zupin L, Ottaviani G, Rupel K, Celsi F, Genovese G, Boniotto M, Crovella S, Marzano AV. Photobiomodulation as potential novel third line tool for non-invasive treatment of hidradenitis suppurativa. G Ital Dermatol Venereol. 2020 Feb;155(1):88-98. doi: 10.23736\u002FS0392-0488.19.06247-3. Epub 2019 Apr 23.",{"pmid":236,"type":194,"citation":237},"37888594","Calderon-Ruiz P, Haist G, Mascus A, Holguin-Rocha AF, Koliopoulos P, Daniel T, Velez G, Londono-Renteria B, Grondahl B, Tobon-Castano A, Gehring S. Multiplex Reverse Transcription Polymerase Chain Reaction Combined with a Microwell Hybridization Assay Screening for Arbovirus and Parasitic Infections in Febrile Patients Living in Endemic Regions of Colombia. Trop Med Infect Dis. 2023 Oct 6;8(10):466. doi: 10.3390\u002Ftropicalmed8100466.",{"pmid":239,"type":194,"citation":240},"38788538","Choe YH, Jo MG, Kim BG, Lee S, Lee B, Kim SH, Seong H, Yoo WS, Kim M, Lee DK, Kim SJ, Yun SP, Kim M. The autoimmune response induced by alpha-synuclein peptides drives neuronal cell death and glial cell activation. J Autoimmun. 2024 Jul;147:103256. doi: 10.1016\u002Fj.jaut.2024.103256. Epub 2024 May 24.",{"pmid":242,"type":194,"citation":243},"37423471","Razumov A, Rogov O, Dylov DV. Optimal MRI undersampling patterns for ultimate benefit of medical vision tasks. Magn Reson Imaging. 2023 Nov;103:37-47. doi: 10.1016\u002Fj.mri.2023.06.020. Epub 2023 Jul 7.",{"pmid":245,"type":194,"citation":246},"27871284","Christersson A, Larsson S, Ostlund B, Sanden B. Radiographic results after plaster cast fixation for 10 days versus 1 month in reduced distal radius fractures: a prospective randomised study. J Orthop Surg Res. 2016 Nov 21;11(1):145. doi: 10.1186\u002Fs13018-016-0478-7.",{"pmid":248,"type":194,"citation":249},"31896545","Mahase E. Star studded mental health film to be shown at 32 football games over weekend. BMJ. 2020 Jan 2;368:m6. doi: 10.1136\u002Fbmj.m6. No abstract available.",{"pmid":251,"type":194,"citation":252},"36306891","Buyuk AF, Stannard JP, Rucinski K, Crecelius CR, Cook JL. The Missouri Osteochondral Preservation System Is Associated With Better Short-Term Outcomes Than Standard Preservation Methods When Performing Osteochondral Allograft Transplantation Using Shell Grafts for Patellofemoral Lesions. Arthroscopy. 2023 Mar;39(3):650-659. doi: 10.1016\u002Fj.arthro.2022.10.007. Epub 2022 Oct 25.",{"pmid":254,"type":194,"citation":255},"31900462","Depil S, Duchateau P, Grupp SA, Mufti G, Poirot L. 'Off-the-shelf' allogeneic CAR T cells: development and challenges. Nat Rev Drug Discov. 2020 Mar;19(3):185-199. doi: 10.1038\u002Fs41573-019-0051-2. Epub 2020 Jan 3.",{"pmid":257,"type":194,"citation":258},"33326791","Kealy L, Di Pietro A, Hailes L, Scheer S, Dalit L, Groom JR, Zaph C, Good-Jacobson KL. The Histone Methyltransferase DOT1L Is Essential for Humoral Immune Responses. Cell Rep. 2020 Dec 15;33(11):108504. doi: 10.1016\u002Fj.celrep.2020.108504.",{"pmid":260,"type":194,"citation":261},"38788539","Franco C, Giannella A, Gasparotto M, Zanatta E, Ghirardello A, Pettorossi F, Rahme Z, Depascale R, Ragno D, Bevilacqua G, Bellis E, Iaccarino L, Doria A, Ceolotto G, Gatto M. Circulating extracellular vesicles and small non-coding RNAs cargo in idiopathic inflammatory myopathies reveal differences across myositis subsets. J Autoimmun. 2024 Jul;147:103255. doi: 10.1016\u002Fj.jaut.2024.103255. Epub 2024 May 25.",{"pmid":263,"type":264,"citation":265},"36762851","RESULT","Rodriguez-Otero P, Ailawadhi S, Arnulf B, Patel K, Cavo M, Nooka AK, Manier S, Callander N, Costa LJ, Vij R, Bahlis NJ, Moreau P, Solomon SR, Delforge M, Berdeja J, Truppel-Hartmann A, Yang Z, Favre-Kontula L, Wu F, Piasecki J, Cook M, Giralt S. Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2023 Mar 16;388(11):1002-1014. doi: 10.1056\u002FNEJMoa2213614. Epub 2023 Feb 10.",{"pmid":267,"type":264,"citation":268},"37272512","San-Miguel J, Dhakal B, Yong K, Spencer A, Anguille S, Mateos MV, Fernandez de Larrea C, Martinez-Lopez J, Moreau P, Touzeau C, Leleu X, Avivi I, Cavo M, Ishida T, Kim SJ, Roeloffzen W, van de Donk NWCJ, Dytfeld D, Sidana S, Costa LJ, Oriol A, Popat R, Khan AM, Cohen YC, Ho PJ, Griffin J, Lendvai N, Lonardi C, Slaughter A, Schecter JM, Jackson CC, Connors K, Li K, Zudaire E, Chen D, Gilbert J, Yeh TM, Nagle S, Florendo E, Pacaud L, Patel N, Harrison SJ, Einsele H. Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. N Engl J Med. 2023 Jul 27;389(4):335-347. doi: 10.1056\u002FNEJMoa2303379. Epub 2023 Jun 5.",{"pmid":270,"type":264,"citation":271},"33626253","Munshi NC, Anderson LD Jr, Shah N, Madduri D, Berdeja J, Lonial S, Raje N, Lin Y, Siegel D, Oriol A, Moreau P, Yakoub-Agha I, Delforge M, Cavo M, Einsele H, Goldschmidt H, Weisel K, Rambaldi A, Reece D, Petrocca F, Massaro M, Connarn JN, Kaiser S, Patel P, Huang L, Campbell TB, Hege K, San-Miguel J. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2021 Feb 25;384(8):705-716. doi: 10.1056\u002FNEJMoa2024850.",{"pmid":273,"type":264,"citation":274},"38230766","Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322\u002Fcaac.21820. Epub 2024 Jan 17.",{"pmid":276,"type":264,"citation":277},"38703748","Sattler C, Ceylan B, Hoffmann L, Juric A, Kraus J, Marandi S, Shahnazari A, Ruhl M. Sequence confirmation of synthetic DNA exceeding 100 nucleotides using restriction enzyme mediated digestion combined with high-resolution tandem mass spectrometry. J Pharm Biomed Anal. 2024 Aug 1;245:116180. doi: 10.1016\u002Fj.jpba.2024.116180. Epub 2024 Apr 29.",{"pmid":279,"type":264,"citation":280},"32989091","Nabhan M, Legrand FX, Le-Minh V, Robin B, Bechara R, Huang N, Smadja C, Pallardy M, Turbica I; ABIRISK Consortium. The FcgammaRIIa-Syk Axis Controls Human Dendritic Cell Activation and T Cell Response Induced by Infliximab Aggregates. J Immunol. 2020 Nov 1;205(9):2351-2361. doi: 10.4049\u002Fjimmunol.1901381. Epub 2020 Sep 28.",{"pmid":282,"type":264,"citation":283},"35177672","Shi F, Pang Z, Liu C, Zhou L, Tan C, Ren J, Ye X, Feng H, Liu Z. Whole-transcriptome analysis and construction of an anther development-related ceRNA network in Chinese cabbage (Brassica campestris L. ssp. pekinensis). Sci Rep. 2022 Feb 17;12(1):2667. doi: 10.1038\u002Fs41598-022-06556-2.",[285],{"label":286,"url":287},"Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. U.S. Dept. of Health \\& Human Services, NIH, NCI; 2017.","https:\u002F\u002Fdctd.cancer.gov\u002Fresearch\u002Fctep-trials\u002Ffor-sites\u002Fadverse-events\u002Fctcae-v5-5x7.pdf",{"nct_id":4,"conditions":289,"biomarkers":290},[18],[],{"nct_id":4,"found":14,"summary":292,"prompt_version":302},{"design":293,"status":294,"heading":295,"summary":296,"follow_up":297,"word_count":298,"commitments":299,"compensation":300,"drugs_mentioned":301},"This is an interventional study, meaning participants will receive a specific treatment. It is a feasibility study, not specifying a phase, and plans to enroll 22 participants.","completed","Iberdomide Before CAR-T for Relapsed\u002FRefractory Multiple Myeloma","This study is looking at whether giving a drug called iberdomide (CC-220) before a procedure called leukapheresis can improve the health of your T cells. T cells are a type of white blood cell collected for CAR-T cell therapy, a treatment for relapsed\u002Frefractory multiple myeloma (a type of blood cancer that has returned or not responded to previous treatment). Researchers hope that healthier T cells will lead to a better response to CAR-T therapy. You would receive iberdomide for 28 days, then have your T cells collected for CAR-T. The main goal is to see if iberdomide increases a specific type of T cell called effector memory T cells. This study plans to enroll 22 participants, but its current status is unclear.","Participants will be monitored for clinical efficacy and side effects for up to one year after CAR-T therapy.",122,"You would take iberdomide capsules daily for 21 days, followed by 7 days off, for one 28-day cycle. Blood samples will be collected before and after iberdomide, and then daily, weekly, and monthly for up to one year after CAR-T infusion.","Not stated in the trial record.",[23],"v2"]