[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hellenic Society of Hematology\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":118},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,67,97],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100594446","phase-2-a-phase-ii-trial-aiming-to-investigate-the-safety-and-clinical-activity-of-belantamab-mafodotin-in-adult-patients-with-primary-immune-thrombocytopenia-previously-treated-with-a-thrombopoietin-receptor-agonist-andor-rituximab-after-corticosteroid-first-line-therapy-100594446",false,"NCT07019545","A PHASE II TRIAL AIMING TO INVESTIGATE THE SAFETY AND CLINICAL ACTIVITY OF BELANTAMAB MAFODOTIN IN ADULT PATIENTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA PREVIOUSLY TREATED WITH A THROMBOPOIETIN RECEPTOR AGONIST AND\u002FOR RITUXIMAB AFTER CORTICOSTEROID FIRST-LINE THERAPY","BONSAI","Inclusion Criteria:\n\n1. Participant must be 18 years or older.\n2. Primary ITP with platelet cell count of less than 30x10\\^9\u002FL.\n3. Prior first-line therapy with corticosteroids.\n4. Prior second-line therapy with TPO-RA and\u002For rituximab and failure to achieve or retain response.\n5. Adequate organ system function as defined by the below laboratory assessments. Hematologic\n\n   1. Absolute neutrophil count ≥1.5 X 10\\^9\u002FL; granulocyte colony stimulating factor use within the past 14 days is NOT permitted.\n   2. Hemoglobin ≥8.0 g\u002FdL; transfusions within the past 14 days are NOT permitted. Erythropoietin use is allowed. Hepatic\n\n   \u003C!-- -->\n\n   1. Total bilirubin ≤1.5xULN (isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C35%).\n   2. Alanine aminotransferase ≤ 2.5xULN. Renal\n\n   a. Estimate glomerular filtration rate ≥30 mL\u002Fmin\u002F1.73 m\\^2; calculated using the Modified Diet in Renal Disease formula.\n6. Female participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n   * Is not a woman of childbearing potential (WOCBP) defined as follows:\n\n     1. ≥45 years of age and has not had menses for \\>1 year.\n     2. Participants who have been amenorrhoeic for \\\u003C2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation.\n     3. Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure. OR\n   * Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), preferably with low user dependency during the intervention period and for 4 months after the last dose of belantamab mafodotin and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of trial intervention.\n   * WOCBP must have a negative highly sensitive serum pregnancy test at screening within 72 hours of dosing on C1D1 and agree to use a highly effective method of contraception during the trial and for 4 months after the last dose of belantamab mafodotin. Additional requirements for pregnancy testing during and after trial intervention are provided in Section 10. Trial Procedures and Visit Schedule. The investigator is responsible for a review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy.\n7. Male participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials: Male participants are eligible to participate if they agree to the following during the intervention period and until 6 months after the last dose of belantamab mafodotin, whichever is longer, to allow for clearance of any altered sperm.\n\n   • Refrain from donating sperm\n\n   PLUS either:\n   * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, OR\n   * Must agree to use contraception\u002Fbarrier as detailed below:\n\n   Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \\\u003C1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females).\n8. Eastern Cooperative Oncology Group Performance (ECOG) Status ≤ 2.\n9. Participants must be able to understand the trial procedures and agree to participate in the trial by providing written informed consent.\n\nExclusion Criteria:\n\n1. Secondary ITP including:\n\n   i. Drug induced ITP. ii. ITP associated with any autoimmune disorders (e.g., systemic lupus erythematosus and rheumatoid arthritis). iii. ITP associated with chronic infection (e.g., human immunodeficiency virus, hepatitis C virus and helicobacter pylori). iv. ITP associated with malignancy (e.g., chronic lymphocytic leukemia or large granular T-lymphocyte lymphocytic leukemia). v. ITP associated with chronic infection.\n2. Chronic liver disease. Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice. NOTE: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) is acceptable if participant otherwise meets entry criteria.\n3. To be seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]) at screening or within 3 months prior to first dose of trial treatment.\n\n   NOTE 1: Participants with resolved infection (i.e., participants who are positive for antibodies to hepatitis B core antigen \\[anti-HBc\\] or antibodies to hepatitis B surface antigen \\[anti-HBs\\]) must be screened using real-time polymerase chain reaction (PCR). Those who are PCR positive will be excluded.\n\n   NOTE 2: presence of ant-iHBs indicating previous vaccination will not constitute an exclusion criterion.\n4. To be seropositive for hepatitis C at screening or within 3 months prior to first dose of trial treatment.\n\n   NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained. Hepatitis RNA testing is optional and participants with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing.\n5. Known HIV infection unless the participant can meet all of the following criteria:\n\n   1. Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load \\\u003C400 copies\u002FmL\n   2. CD4+ T-cell (CD4+) counts ≥350 cells\u002FuL\n   3. No history of AIDS-defining opportunistic infections within the last 12 months NOTE: consideration must be given to ART and prophylactic antimicrobials that may have a drug:drug interaction and\u002For overlapping toxicities with belantamab mafodotin or other combination products as relevant.\n6. Active infection requiring treatment.\n7. Presence of active renal condition (infection, requirement for dialysis, or any other significant condition that could affect participant's safety).\n8. Any serious and\u002For unstable pre-existing medical or psychiatric disorder, or other conditions (including laboratory abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance to the trial procedures.\n9. Participant must not have received a live or live-attenuated vaccine within 30 days prior to first dose of belantamab mafodotin.\n10. Current corneal epithelial disease except for mild punctate keratopathy. NOTE: Participants with mild punctate keratopathy are allowed. Mild (Grade 1) punctuate keratopathy is characterized by the appearance of only a few, if any, microcyst-like epithelial changes, as identified in the slit-lamp examination, with a low density (non-confluent), and predominantly (≥80%) located in the periphery of the cornea.\n11. Known intolerance or immediate or delayed hypersensitivity reaction or idiosyncratic reaction to: drugs chemically related to belantamab mafodotin, or any of the components of the trial treatment; or infused protein products, sucrose, histidine, and polysorbate 80.\n12. Use of an investigational drug within 14 days or 5 half-lives (whichever is shorter) preceding the first dose of trial drug.\n13. Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of trial drug. Please note, monoclonal antibodies for serious conditions unrelated to MM, such as COVID, may be permitted but need to be discussed with the Sponsor.\n14. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasmaproliferative disorder, skin changes) or active plasma cell leukemia at the time of screening.\n15. Evidence of active mucosal or internal bleeding.\n16. Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.\n17. Major surgery within 4 weeks before the first dose of trial drug NOTE 1: participant must be clinically stable following a major surgery to be entered in the trial.\n\nNOTE 2: major surgery shall be defined based on the Investigator's judgment according to the extent and complexity of the procedure, its pathophysiological consequences and consecutive clinical outcomes. 18. Evidence of cardiovascular risk including any of the following: i. Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities, second degree (Mobitz Type II), or third degree atrioventricular block. ii. Screening 12-lead ECG showing a baseline QT interval \\>470 msec iii. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening. iv. Class III or IV heart failure as defined by the New York Heart Association functional classification system (Appendix 3 - New York Heart association (NYHA) Classification v. Uncontrolled hypertension.","ALL","18 Years",{"count":19,"type":20},14,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a Phase II open label, prospective, multicenter trial designed to assess the safety and clinical activity of belantamab mafodotin in adult patients with primary immune thrombocytopenia (ITP) previously treated with a thrombopoietin receptor agonist (TPO-RA) and\u002For rituximab after first-line treatment with corticosteroids. Overall, 14 participants will be enrolled in the trial. Participants' follow-up will continue for up to 12 months after the last participant is enrolled. The accrual period will be approximately 12 months.\n\nTrial treatment will be given in 28-day cycles for a total period of one year per patient or until treatment failure, physician decision, unacceptable toxicity, withdrawal of consent, or death (whichever occurs first). Participants without confirmed Response (R) or better after two infusions with belantamab mafodotin will be discontinued from trial treatment and will not be replaced.",[26],"Primary Immune Thrombocytopenia (ITP)","NOT_YET_RECRUITING","2025-06-05",{"date":30,"type":31},"2025-06-13","ACTUAL",{"date":33,"type":20},"2025-06-20",{"date":35,"type":20},"2027-06-20",{"name":37,"class":38},"Hellenic Society of Hematology","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100565005","phase-2-an-investigator-initiated-phase-ii-multicenter-open-label-single-arm-prospective-clinical-trial-to-evaluate-the-efficacy-and-safety-of-alternating-bortezomib-based-regimens-in-combination-with-daratumumab-followed-by-maintenance-with-daratumumab-in-the-frontline-setting-of-primary-plasma-cell-l-100565005","NCT06636552","An Investigator-Initiated, Phase II, Multicenter, Open-Label, Single-Arm, Prospective Clinical Trial to Evaluate the Efficacy and Safety of Alternating Bortezomib-Based Regimens in Combination With DaratUMumab Followed by Maintenance With Daratumumab in the Frontline Setting of Primary Plasma CEll L","An Investigator-Initiated, Phase II, Multicenter, Open-Label, Single-Arm, Prospective Clinical Trial to Evaluate the Efficacy and Safety of Alternating Bortezomib-Based Regimens in Combination With DaratUMumab Followed by Maintenance With Daratumumab in the Frontline Setting of Primary Plasma CEll LEukemIA: A Trial of the Greek Myeloma Study Group The \" EUMELEIA \" Study","EUMELEIA","Inclusion\n\n1. Age between 18 and 80 years (inclusive) at the time of signing the informed consent.\n2. Patients newly diagnosed with documented pPCL as defined by the current IMWG criteria for PCL and MM:\n\n   * Documented presence of ≥5% PBPCs and\u002For absolute number ≥0.5 × 103\u002FμL, assessed either morphologically in the peripheral blood (PB) smear or by flow cytometry, and confirmation of plasma cell clonality by flow cytometry\n   * Clonal BMPCs ≥10% or biopsy-proven bony or extramedullary plasmacytoma\n   * At least one of the following myeloma defining events:\n   * Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically (one or more of the following):\n   * Hypercalcemia: serum calcium \\>0.25 mmol\u002FL (\\>1 mg\u002FdL) higher than the upper limit of normal (ULN) or \\>2.75 mmol\u002FL (\\>11 mg\u002FdL)\n   * Renal insufficiency: Creatinine clearance (CrCl) \\\u003C40 mL\u002Fmin (measured or estimated by validated equations) or serum creatinine \\>177 μmol\u002FL (\\>2 mg\u002FdL)\n   * Anemia: hemoglobin value of \\>20 g\u002FL below the lower limit of normal (LLN), or a hemoglobin value \\\u003C100 g\u002FL\n   * Bone lesions: One or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT.\n   * Any one or more of the following biomarkers of malignancy:\n   * Clonal bone marrow plasma cell percentage ≥60%\n   * Involved:Uninvolved serum free light chain (sFLC) ratio ≥100 \\>1 focal lesions on MRI studies (each focal lesion must be 5 mm or more in size).\n3. Measurable disease by protein electrophoresis as defined by any of the following:\n\n   * Serum M-protein level:\n   * For IgG MM: ≥1.0 g\u002FdL or urine M-protein level ≥200 mg\u002F24 hours\n   * For IgA, IgE and IgM MM: ≥0.5 g\u002FdL or urine M-protein level ≥200 mg\u002F24 hours\n   * For IgD MM: ≥0.05 g\u002FdL or urine M-protein level ≥200 mg\u002F24 hours\n   * Light chain MM without measurable disease in the serum or the urine: sFLC ≥10 mg\u002FdL (involved light chain) and abnormal sFLC κ\u002Fλ ratio.\n4. Patients for whom high-dose therapy, with or without stem cell transplantation, is part of the intended treatment plan.\n5. Patient not currently or previously treated with any systemic therapy or stem cell transplant for any plasma cell dyscrasia, apart from a short course of corticosteroid therapy (equivalent of dexamethasone 40 mg\u002Fday for up to 4 days).\n6. Adequate bone marrow function as determined by the following:\n\n   * Hemoglobin ≥7.0 g\u002FdL \\[≥4.34 mmol\u002FL; prior red blood cell transfusion or recombinant human erythropoietin use is permitted\\]\n   * Absolute neutrophil count ≥1.0 x 109\u002FL \\[granulocyte-colony stimulating factor use is permitted\\]\n   * Platelet count ≥50 x 109\u002FL if disease involvement in bone marrow is \\>50%; otherwise ≥75% x 109\u002FL.\n7. Adequate liver function as determined by the following:\n\n   * Serum Aspartate Transaminase ≤2.5 x ULN\n   * Serum Alanine Aminotransferase ≤2.5 x ULN\n   * Total bilirubin ≤1.5 x ULN (for subjects with congenital bilirubinemia, such as Gilbert syndrome, direct bilirubin ≤1.5 x ULN is required).\n8. Adequate renal function as determined by estimated CrCl ≥20 mL\u002Fmin.\n9. Eastern Cooperative Oncology Group (ECOG) Performance status 0-3.\n10. If females of childbearing potential (FCBP), the following apply:\n\n    * Willingness to use an acceptable form of birth control during the clinical trial. FCBPs must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously during the treatment period, and for 3 months after the last dose of any component of the treatment regimen.\n    * They must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 3 months after receiving the last dose of any component of the study treatment.\n    * They must have 2 negative serum or urine pregnancy tests; one at Screening and in particular within 10-14 days prior to C1D1, and the second within 24 hours prior to C1D1.\n11. If male subjects of reproductive potential who are sexually active with FCBPs the following apply.\n\n    * Must always use a latex or synthetic condom during the study and for 3 months after discontinuing study treatment (even if they have undergone a successful vasectomy).\n    * They must not donate sperm during the study or for 3 months after the last dose of study treatment.\n12. Patients who are able to comprehend and willing to follow the requirements of the study.\n13. Patients (or patients' legally acceptable representative as applicable) who are able to understand and willing to provide voluntary written informed consent before any clinical trial-related procedure is performed.\n\nExclusion\n\n1. Patients with secondary PCL.\n2. Prior or concurrent invasive malignancy (other than PCL) within 5 years of date of study treatment initiation except for the following:\n\n   * Malignancy treated with curative intent and with no known active disease present for ≥3 years before study treatment initiation.\n   * Adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix or breast, incidental histologic finding of prostate cancer (T1a or T1b) or other non-invasive lesion that, as per Investigator's judgement, is considered cured with minimal risk of recurrence over the next 3 years.\n3. Radiation therapy within 14 days before study treatment initiation.\n4. Plasmapheresis within 28 days before study treatment initiation.\n5. Exhibiting clinical signs of meningeal or central nervous system involvement by PCL.\n6. Patients with peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.\n7. Concurrent systemic amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and\u002For skin changes), active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease, and any other medical condition\u002Fdisease that is likely to interfere with the study procedures or results, or that in the opinion of the Investigator, places the subject at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study.\n8. Known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second \\[FEV1\\] \\\u003C50% of predicted normal.\n9. Known moderate or severe persistent asthma within the past 2 years, or the patient currently has uncontrolled asthma of any classification.\n10. Any of the following:\n\n    * Known seropositivity for human immunodeficiency virus\n    * Seropositivity for hepatitis B virus defined by a positive test for hepatitis B surface antigen.\n    * Known seropositivity for hepatitis C virus defined by anti-HCV antibody positive or HCV-RNA quantitation positive.\n11. Clinically significant cardiac disease including:\n\n    * Myocardial infarction within 6 months before study treatment initiation\n    * Unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV)\n    * Pericardial disease\n    * Cardiac amyloidosis\n    * Uncontrolled cardiac arrhythmia (NCI CTCAE v5 Grade 2 or higher) or clinically significant electrocardiogram (ECG) abnormalities\n    * Screening 12-lead ECG showing a baseline QT interval \\>470 msec (except for subjects with pacemaker)\n    * Screening transthoracic echocardiogram showing left ventricular ejection fraction (LVEF) \\\u003C40% (screening TTE is required only for subjects aged ≥ 65 years).\n12. Receipt of a strong CYP3A4 inducer within 5 half-lives prior to study treatment initiation.\n13. Known allergies, hypersensitivity, or intolerance to boron or mannitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients, or known sensitivity to mammalian-derived products.\n14. Gastrointestinal disease that may significantly affect the absorption of oral drugs as per Investigator's discretion.\n15. Vaccination with live attenuated vaccines within 4 weeks of study treatment initiation.\n16. Major surgery within 2 weeks before study treatment initiation or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to start the study treatment.\n17. Concurrent use of other anti-cancer agents\u002Ftreatments.\n18. Subject is known or suspected of not being able to comply with the study protocol (e.g., because of alcoholism, drug dependency, or psychological disorder). Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n19. Females who are pregnant, breast feeding, or planning to become pregnant while enrolled in this study or within 3 months following the last dose of any component of the study treatment.\n20. Males who plan to father a child while enrolled in this study or within 3 months following the last dose of any component of the study treatment.\n21. Patients who currently receive treatment with any investigational drug\u002Fvaccine\u002Fdevice\u002Fintervention or who have received any investigational product within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the screening.\n22. Contraindications to the use of any components of the study treatment (daratumumab, bortezomib, dexamethasone, cyclophosphamide, doxorubicin) per local prescribing information.","80 Years",{"count":50,"type":20},43,[23],"The primary objective of this study is to evaluate the efficacy of the alternating D-PAD\u002FD-CVD induction regimen followed by D-CVD consolidation regimen and maintenance with daratumumab monotherapy, in terms of PFS, in the first-line setting of pPCL.",[54],"Primary Plasma Cell Leukemia",[56],"primary plasma cell leukemia","RECRUITING","2024-10-09",{"date":60,"type":31},"2024-10-10",{"date":62,"type":31},"2021-11-19",{"date":64,"type":20},"2029-01-05",{"name":37,"class":38},7,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100483343","phase-1-a-study-to-investigate-safety-and-clinical-activity-of-belantamab-mafodotin-in-combination-with-lenalidomide-dexamethasone-and-nirogacestat-in-patients-with-transplant-ineligible-newly-diagnosed-multiple-myeloma-100483343","NCT05573802","A Study to Investigate Safety and Clinical Activity of Belantamab Mafodotin in Combination With Lenalidomide, Dexamethasone and Nirogacestat in Patients With Transplant Ineligible Newly Diagnosed Multiple Myeloma","A Phase 1\u002F2, Dose and Schedule Evaluation Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin Administrated in Combination With Lenalidomide, Dexamethasone and Nirogacestat in Patients With Transplant Ineligible Newly Diagnosed Multiple Myeloma","Inclusion Criteria:\n\n1. Participant must be \\>18 years of age\n2. Monoclonal plasma cells in the bone marrow (BM) ≥10% or presence of a biopsy proven plasmacytoma and documented Multiple Myeloma (MM) satisfying at least one of the calcium, renal, anemia, bone (CRAB) criteria or biomarkers of malignancy criteria:\n\n   CRAB criteria:\n\n   i. Hypercalcemia: serum calcium \\>0.25 mmol\u002FL (\\>1 mg\u002FdL) higher than upper limit of normal (ULN) or \\>2.75 mmol\u002FL (\\>11 mg\u002FdL).\n\n   ii. Renal insufficiency: creatinine clearance (CrCI) \\\u003C40mL\u002Fmin or serum creatinine \\>177 μmol\u002FL (\\>2 mg\u002FdL).\n\n   iii. Anemia: hemoglobin \\>2 g\u002FdL below the lower limit of normal or hemoglobin \\\u003C10 g\u002FdL.\n\n   iv. Bone lesions: one or more osteolytic lesions on skeletal radiography, Computed tomography (CT), or Positron emission tomography (PET-CT).\n\n   Biomarkers of Malignancy:\n   1. Clonal BM plasma cell percentage ≥60%.\n   2. Involved: uninvolved serum free light chain (sFLC) ratio ≥100.\n   3. More than 1 focal lesion on magnetic resonance imaging (MRI) studies.\n3. Must have at least ONE aspect of measurable disease, defined as one of the following:\n\n   * Urine M-protein excretion ≥200 mg\u002F24 hrs (≥0.2 g\u002F24 hrs), or\n   * Serum M-protein concentration ≥0.5 g\u002FdL (≥5.0 g\u002FL), or\n   * Serum FLC assay: involved FLC level ≥10 mg\u002FdL (≥100 mg\u002FL) and an abnormal serum FLC ratio (\\\u003C0.26 or \\>1.65).\n4. Not a candidate for high-dose chemotherapy with autologous stem cell transplantation due to presence of significant comorbid condition(s), such as cardiac, pulmonary or other major organ dysfunction that are likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation. The patients will be assessed with the IMWG frailty index, a scoring system based on age, comorbidities, and cognitive and physical conditions, which is recommended by the European Society for Medical Oncology (ESMO) guidelines. Patients with International Myeloma Working Group (IMWG) frailty index score 1 or 2 will be considered transplant ineligible. The reason(s) for transplant ineligibility will be collected in the case report forms (CRFs).\n5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2.\n6. Adequate organ system function as defined by the below laboratory assessments. Hematologic\n\n   * Absolute neutrophil count (ANC) ≥1.25 X 10\\^9\u002FL; granulocyte colony-stimulating factor (G-CSF) use for the past 14 days is NOT allowed.\n   * Hemoglobin ≥8.0 g\u002FdL; transfusions are not permitted in the past 14 days prior to the assessment. Erythropoietin use is allowed.\n   * Platelet count ≥50 x 10\\^9\u002FL if the BM is \\>50% involved in myeloma. Otherwise, ≥75 x 10\\^9\u002FL; transfusions or platelet stimulating agents are NOT allowed in the past 14 days prior to the assessment.\n\n   Hepatic\n   * Total bilirubin ≤1.5xULN (isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C35%).\n   * ALT ≤ 2.5xULN. Renal\n   * Estimate glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73 m2; calculated using the Modified Diet in Renal Disease (MDRD) formula.\n   * Spot urine (albumin\u002Fcreatinine ratio) \\\u003C500 mg\u002Fg (56 mg\u002Fmmol) OR\n   * Urine Dipstick: Negative trace; if ≥1+ only eligible if confirmed \\\u003C500 mg\u002Fg \\[56 mg\u002Fmmol\\] by albumin\u002Fcreatinine ratio (spot urine from first void).\n7. Female participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies:\n\n   A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n   * Is not a woman of childbearing potential (WOCBP) defined as follows:\n   * ≥ 45 years of age and has not had menses for \\> 1 year\n   * Patients who have been amenorrhoeic for \\\u003C 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\n   * Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.\n\n   OR\n   * Is a WOCBP and using two methods of reliable birth control (one method that is highly effective and one additional effective \\[barrier\\] method), beginning 4 weeks before initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide treatment. WOCBP participants must use one method of reliable birth control that is highly effective for 4 months following discontinuation of belantamab mafodotin. WOCBP must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction during treatment, during dose interruptions and for 28-days following the last dose of lenalidomide or 4 months following discontinuation of belantamab mafodotin treatment, whichever is longer.\n\n   A WOCBP must have two negative pregnancy tests before therapy initiation. The first test should be performed within 10-14 days, and the second test within 24 hours before the start of lenalidomide therapy.\n\n   The participant should not receive lenalidomide until the investigator has verified that the results of these pregnancy tests are negative. The investigator should evaluate the effectiveness of the contraceptive method in relation to the first dose of the study treatment. The investigator is responsible for a review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy.\n\n   WOCBP is a female who:\n   * has achieved menarche at some time point\n   * has not undergone a hysterectomy or bilateral oophorectomy or\n   * has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n8. Male participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies:\n\n   Male participants are eligible to participate if they agree to the following during the intervention period and until 28 days after the last dose of lenalidomide or 6 months after the last dose of belantamab mafodotin, whichever is longer, to allow for clearance of any altered sperm.\n   * Refrain from donating sperm\n\n   PLUS either:\n   * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, OR\n   * Must agree to use contraception\u002Fbarrier as detailed below:\n\n   Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \\\u003C1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females).\n9. Participants must be able to understand the study procedures and agree to participate in the study by providing written informed consent.\n\nExclusion Criteria:\n\n1. Prior systemic therapy for MM or Smoldering MM.\n\n   * NOTE 1: An emergency course of steroids (defined as not greater than 40 mg of dexamethasone \\[or equivalent\\] per day for a maximum of 4 days \\[i.e., a total of 160 mg\\]) is permitted.\n   * NOTE 2: Focal palliative radiation is permitted before enrollment, provided that: it occurred at least 2 weeks before the first dose of the study drug; the participant has recovered from radiation-related toxicities; and the participant did not require corticosteroid administration (for a longer period than that specified in NOTE 1 above) for radiation-induced AEs.\n2. Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Toxicity Criteria for AEs version 5.\n3. Major surgery within 2 weeks before the first dose of the study drug.\n\n   * NOTE 1: patients who underwent major surgery must be clinically stable to be enrolled in the study.\n   * NOTE 2: major surgery shall be defined based on the Investigator's judgment according to the extent and complexity of the procedure, its pathophysiological consequences and consecutive clinical outcomes.\n4. Presence of active renal condition (infection, requirement for dialysis or any other significant condition that could affect the participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided that they fulfil the other inclusion criteria.\n5. Any serious and\u002For unstable pre-existing medical, psychiatric disorder, or other conditions (including laboratory abnormalities) that could interfere with the participant's safety, obtaining informed consent, or compliance with the study procedures.\n6. Evidence of active mucosal or internal bleeding uncontrolled by local therapy and not explained by reversible coagulopathy.\n7. Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease as per the investigator's assessment).\n8. Participants with previous or concurrent malignancies other than MM are excluded. Exceptions are surgically treated cervical carcinoma in situ or any other malignancy that has been considered medically stable for at least 2 years. The participant must not be receiving active therapy other than hormonal therapy for this disease.\n\n   * NOTE: Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction.\n9. Evidence of cardiovascular risk including any of the following:\n\n   * Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities, second degree (Mobitz Type II), or third degree atrioventricular (AV) block.\n   * History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of screening.\n10. Class III or IV heart failure as defined by the New York Heart Association functional classification system.\n11. Uncontrolled hypertension.\n12. Active infection requiring treatment.\n13. Known HIV infection, unless the participant can meet all of the following criteria:\n\n    * Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load \\\u003C400 copies\u002FmL.\n    * CD4+ T-cell (CD4+) count ≥350 cells\u002FuL.\n    * No history of AIDS-defining opportunistic infections within the last 12 months.\n\n      * NOTE: consideration must be given to ART and prophylactic antimicrobials that may have a drug:drug interaction and\u002For overlapping toxicities with belantamab mafodotin or other combination products as relevant\n14. Seropositivity for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]).\n\n    * NOTE 1: Participants with resolved infection (i.e., participants who are positive for antibodies to hepatitis B core antigen \\[antiHBc\\] or antibodies to hepatitis B surface antigen \\[antiHBs\\]) must be screened using real-time polymerase chain reaction (PCR). Those who are PCR positive will be excluded.\n    * NOTE 2: presence of antiHBs indicating previous vaccination will not constitute an exclusion criterion.\n15. Positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months before the first dose of the study treatment unless the participant can meet the following criteria:\n\n    * RNA test negative\n    * Successful anti-viral treatment (usually 8 weeks duration) is required, followed by a negative hepatitis C virus RNA test after a washout period of at least 4 weeks.\n16. Current corneal epithelial disease except for mild punctate keratopathy.\n\n    * NOTE: Participants with mild punctate keratopathy are allowed. Mild (Grade 1) punctuate keratopathy is characterized by the appearance of only a few, if any, microcyst-like epithelial changes (MECs), as identified in the slit-lamp examination, with a low density (non-confluent), and predominantly (≥80%) located in the periphery of the cornea\n17. Intolerance or contraindications to anti-viral prophylaxis.\n18. Unable to tolerate antithrombotic prophylaxis.\n19. AL amyloidosis (light chain amyloidosis), active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) or active plasma cell leukemia at the time of screening.\n20. Exhibiting clinical signs of or with known history of meningeal or central nervous system involvement by MM.\n21. Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin or any of the components of the study treatment.\n22. Use of an investigational drug within 14 days or 5 half-lives (whichever is shorter) preceding the first dose of study drug.\n23. Plasmapheresis within 7 days before the first dose of the study drug.\n24. Participants with active small and\u002For large intestinal disease which is not adequately controlled with the appropriate treatment (e.g., uncontrolled diarrheal disease).\n25. Participants with uncontrolled skin disease.\n26. Participants with any condition causing hypophosphatemia, hypokalemia or hypomagnesemia which is refractory to electrolyte replacement.\n27. Participants with previous administration of a gamma secretase inhibitor.\n28. Participants with concomitant administration of a strong or moderate CYP3A4 inhibitor or inducer.\n29. Any serious and\u002For unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.\n30. Participant must not have received a live or live-attenuated vaccine within 30 days prior to first dose of belantamab mafodotin.\n31. Participant should not use contact lenses while receiving belantamab mafodotin.\n32. Because of the embryo-fetal risk of lenalidomide, all participants must adhere to the lenalidomide pregnancy prevention program applied in their region.",{"count":75,"type":20},36,[77,23],"PHASE1","This is a phase 1\u002F2, open-label study designed to assess the safety and clinical activity of different belantamab mafodotin doses in combination with lenalidomide, dexamethasone and nirogacestat in patients with transplant ineligible newly diagnosed multiple myeloma.\n\nThis will be a 2-part study. In part 1 participants will be enrolled in one cohort to receive belantamab mafodotin in combination with lenalidomide, dexamethasone and nirogacestat and will determine the recommended phase 2 dose (RP2D) to be further evaluated for safety and clinical activity in the dose expansion cohort. The RP2D dose will be used in future studies in the transplant-ineligible newly diagnosed multiple myeloma (NDMM) setting. In the dose expansion phase (Part 2) an expansion cohort will be treated with the RP2D. The expansion cohort will randomize participants (1:1) in two groups to evaluate two alternate dose modification guidelines for corneal AEs. Part 2 of the study will also evaluate an alternative dose modification guideline for corneal adverse events (AEs).\n\nOverall, approximately 36 participants will be enrolled in the study. Participant follow-up will continue up to 3 years after the last participant is enrolled (follow-up period range: 3-4 years). The estimated accrual period will be 12 months, corresponding to an approximate total study duration of 4 years.",[80,81,82,83,84,85,86,87],"Multiple Myeloma","Neoplasms","Neoplasm, Plasma Cell","Gammopathy, Monoclonal","Paraproteinemias","Blood Protein Disorders","Haematologic Disease","Corneal Disease","2023-10-20",{"date":90,"type":31},"2023-10-24",{"date":92,"type":31},"2023-07-14",{"date":94,"type":20},"2026-10-31",{"name":37,"class":38},2,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":117,"locationsCount":4},"100483964","phase-1-a-study-to-investigate-the-safety-and-clinical-activity-of-belantamab-mafodotin-in-combination-with-daratumumab-pomalidomide-and-dexamethasone-in-patients-with-relapsed-refractory-multiple-myeloma-previously-treated-with-one-line-therapy-who-are-lenalidomide-refractory-100483964","NCT05581875","A Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin in Combination With Daratumumab, Pomalidomide and Dexamethasone in Patients With Relapsed\u002F Refractory Multiple Myeloma Previously Treated With One Line Therapy Who Are Lenalidomide Refractory","A Phase 1\u002F2, Dose and Schedule Evaluation Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin Administered in Combination With Daratumumab, Pomalidomide and Dexamethasone in Patients With Relapsed\u002F Refractory Multiple Myeloma Previously Treated With One Line of Therapy Who Are Lenalidomide Refractory.","Inclusion Criteria:\n\n1. Participant must be ≥18 years or older.\n2. Documented diagnosis of Multiple Myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.\n3. Must have at least ONE aspect of measurable disease, defined as one of the following:\n\n   1. Urine M-protein excretion ≥200 mg\u002F24 hrs (≥0.2 g\u002F24 hrs), or\n   2. Serum M-protein concentration ≥0.5 g\u002FdL (≥5.0 g\u002FL), or\n   3. Serum Free Light Chain (FLC) assay: involved FLC level ≥10 mg\u002FdL (≥100 mg\u002FL) and an abnormal serum FLC ratio (\\\u003C0.26 or \\>1.65).\n4. Eastern Cooperative Oncology Group performance status of 0-2.\n5. Adequate organ system function as defined by the below laboratory assessments. Hematologic\n\n   1. Absolute neutrophil count (ANC) ≥1.5 X 109\u002FL; granulocyte colony stimulating factor use within the past 14 days is NOT permitted.\n   2. Hemoglobin ≥8.0 g\u002FdL; transfusions within the past 14 days are NOT permitted. Erythropoietin use is allowed.\n   3. Platelet count ≥50 x 109\u002FL if Bone Marrow (BM) is \\>50% involved in myeloma. Otherwise ≥75 x 109\u002FL; transfusions within the past 14 days are NOT allowed to reach this level.\n\n   Hepatic\n   1. Total bilirubin ≤1.5xULN (isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C35%).\n   2. Alanine aminotransferase (ALT) ≤ 2.5xUpper Limit of Normal (ULN). Renal\n\n   \u003C!-- -->\n\n   1. Estimate glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73 m2; calculated using the Modified Diet in Renal Disease (MDRD) formula.\n   2. Spot urine (albumin\u002Fcreatinine ratio) ≤500 mg\u002Fg (56 mg\u002Fmmol) OR\n   3. Urine Dipstick: Negative trace; if ≥1+ only eligible if confirmed ≤500 mg\u002Fg \\[56 mg\u002Fmmol\\] by albumin\u002Fcreatinine ratio (spot urine from first void).\n6. Female participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies:\n\n   A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n   * Is not a woman of childbearing potential (WOCBP) defined as follows:\n\n     1. ≥45 years of age and has not had menses for \\> 1 year\n     2. Participants who have been amenorrhoeic for \\\u003C 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\n     3. Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.\n\n        OR\n   * Is a WOCBP and using two methods of reliable birth control (one method that is highly effective and one additional effective \\[barrier\\] method), beginning 4 weeks before initiating treatment with pomalidomide, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of pomalidomide treatment. WOCBP participants must use one method of reliable birth control that is highly effective for 4 months following discontinuation of belantamab mafodotin or 3 months following the discontinuation of daratumumab. WOCBP must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction during treatment, during dose interruptions and for 28-days following the last dose of pomalidomide or 3 months following discontinuation of daratumumab treatment or 4 months following discontinuation of belantamab mafodotin treatment whichever is longer.\n\n   A WOCBP must have two negative pregnancy tests before therapy initiation. The first test should be performed within 10-14 days and the second test within 24 hours before the start of pomalidomide therapy.\n\n   The participant should not receive pomalidomide until the Investigator has verified that the results of these pregnancy tests are negative. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment. The Investigator is responsible for a review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy.\n7. Male participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies:\n\n   Male participants are eligible to participate if they agree to the following during the intervention period and until 28 days after the last dose of pomalidomide or 3 months following the discontinuation of daratumumab or 6 months after the last dose of belantamab mafodotin, whichever is longer, to allow for clearance of any altered sperm.\n\n   • Refrain from donating sperm\n\n   PLUS either:\n   * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, OR\n   * Must agree to use contraception\u002Fbarrier as detailed below:\n\n   Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \\\u003C1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females).\n8. Participants must be able to understand the study procedures and agree to participate in the study by providing written informed consent.\n9. Participant must have received only 1 prior line of therapy (including lenalidomide) and be lenalidomide refractory at any lenalidomide dose (i.e., nonresponsive while on lenalidomide therapy, or progresses within 60 days of last therapy with lenalidomide).\n\nExclusion Criteria:\n\n1. Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute, Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 5.\n2. Major surgery within 4 weeks before the first dose of study drug\n\n   * NOTE 1: participant must be clinically stable following a major surgery to be entered in the study.\n   * NOTE 2: major surgery shall be defined based on the Investigator's judgment according to the extent and complexity of the procedure, its pathophysiological consequences and consecutive clinical outcomes.\n3. Presence of active renal condition (infection, requirement for dialysis, or any other significant condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided that they fulfil the other inclusion criteria.\n4. Any serious and\u002For unstable pre-existing medical or psychiatric disorder, or other conditions (including laboratory abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures.\n5. Evidence of active mucosal or internal bleeding uncontrolled by local therapy and not explained by reversible coagulopathy.\n6. Current active unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis (except for Gilbert's syndrome or asymptomatic gallstones; otherwise, stable non-cirrhotic chronic liver disease; or hepatobiliary involvement of malignancy as per the Investigator's assessment).\n7. Participants with previous or concurrent malignancies other than MM are excluded. Exceptions are surgically treated cervical carcinoma in situ, or any other malignancy that has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease.\n\n   * NOTE: Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction.\n8. Evidence of cardiovascular risk including any of the following:\n\n   * Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities, second degree (Mobitz Type II), or third degree atrioventricular block.\n   * Screening 12-lead ECG showing a baseline QT interval \\>470 msec\n   * History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening.\n   * Class III or IV heart failure as defined by the New York Heart Association functional classification system\n   * Uncontrolled hypertension.\n9. Participant has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second \\[FEV1\\] \\\u003C50% of predicted normal), persistent asthma, or a history of asthma within the last 2 years (controlled intermittent asthma or controlled mild persistent asthma is allowed).\n\n   NOTE: Participants with known or suspected COPD must have a FEV1 test at screening.\n10. Active infection requiring treatment.\n11. Known human immunodeficiency virus infection, unless the participant can meet all of the following criteria:\n\n    * Established anti-retroviral therapy for at least 4 weeks and HIV viral load \\\u003C400 copies\u002FmL.\n    * CD4+ T-cell (CD4+) count ≥350 cells\u002FuL.\n    * No history of AIDS-defining opportunistic infections within the last 12 months.\n\n      * NOTE: consideration must be given to ART and prophylactic antimicrobials that may have a drug:drug interaction and\u002For overlapping toxicities with belantamab mafodotin or other combination products as relevant\n12. To be seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]) at screening or within 3 months prior to first dose of study treatment.\n\n    * NOTE 1: Participants with resolved infection (i.e., participants who are positive for antibodies to hepatitis B core antigen \\[antiHBc\\] or antibodies to hepatitis B surface antigen \\[antiHBs\\]) must be screened using real-time polymerase chain reaction (PCR). Those who are PCR positive will be excluded.\n    * NOTE 2: presence of antiHBs indicating previous vaccination will not constitute an exclusion criterion.\n13. Positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months before the first dose of study treatment unless the participant can meet the following criteria:\n\n    * RNA test negative\n    * Successful anti-viral treatment (usually 8 weeks duration) is required, followed by a negative hepatitis C virus (HCV) RNA test after a washout period of at least 4 weeks.\n14. Current corneal epithelial disease except for mild punctate keratopathy.\n\n    * NOTE: Participants with mild punctate keratopathy are allowed.\n15. Intolerance or contraindications to anti-viral prophylaxis.\n16. Unable to tolerate antithrombotic prophylaxis.\n17. Active or history of venous thromboembolism within past 3 months.\n18. AL amyloidosis (light chain amyloidosis), active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) or active plasma cell leukemia at the time of screening.\n19. Exhibiting clinical signs of or with a known history of meningeal or central nervous system involvement by MM.\n20. Known intolerance or immediate or delayed hypersensitivity reaction or idiosyncratic reaction to: drugs chemically related to belantamab mafodotin, or any of the components of the study treatment; daratumumab subcutaneous (SC) or to any of its excipients; or infused protein products, sucrose, histidine, and polysorbate 80.\n21. Use of an investigational drug within 14 days or 5 half-lives (whichever is longer) preceding the first dose of study drug.\n22. Participant who has received prior treatment with daratumumab, pomalidomide or belantamab mafodotin will be excluded.\n\n    * NOTE: Participants who received induction treatment with daratumumab (max 4 cycles) will be allowed as long as 6 months have passed since their treatment with daratumumab and cycle 1 day 1 (C1D1).\n23. Plasmapheresis within 7 days before the first dose of study drug.\n24. Participants with uncontrolled skin disease.\n25. Participant must not have received a live or live-attenuated vaccine within 30 days prior to first dose of belantamab mafodotin.\n26. Participant should not use contact lenses while receiving belantamab mafodotin.",{"count":105,"type":20},48,[77,23],"This is a phase 1\u002F2, open label, single-center study designed to assess the safety and preliminary clinical activity of different belantamab mafodotin doses in combination with daratumumab, pomalidomide, and dexamethasone (DPd) in patients with Relapsed\u002F Refractory Multiple Myeloma (RRMM) previously treated with one line of therapy who are lenalidomide refractory.\n\nThis will be a 2-Part study. Part 1 will evaluate the safety of belantamab mafodotin in combination with DPd in 2 cohorts and determine the Recommended Phase 2 Dose (RP2D). In the dose expansion phase (Part 2) an expansion cohort will be treated with the RP2D. The expansion cohort will randomize participants (1:1) in two groups to evaluate two alternate dose modification guidelines for corneal AEs. Part 2 will further evaluate the safety and assess the preliminary clinical activity of the belantamab mafodotin RP2D in combination with DPd.\n\nOverall, approximately 48 participants will be enrolled in the study. Participant follow-up will continue up to 3 years after the last participant is randomized. The estimated accrual period will be 12 months corresponding to an approximate total study duration of 4 years.",[80,109,81,83,84,85,86,87,110],"Multiple Myeloma in Relapse","Neoplasms, Plasma Cell","2022-10-13",{"date":113,"type":31},"2022-10-17",{"date":115,"type":20},"2022-10-20",{"date":94,"type":20},{"name":37,"class":38},""]