[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Canadian Myeloma Research Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100656893","phase-1-study-of-belantamab-mafodotin-cevostamab-pomalidomide-for-rrmm-patients-maple-100656893",false,"NCT07831122","Study of Belantamab Mafodotin, Cevostamab, Pomalidomide for RRMM Patients (MAPLE)","An Open-Label Phase Ib, Multicenter Study To Evaluate The Safety And Efficacy Of Belantamab Mafodotin Plus Cevostamab And Pomalidomide In Participants With Relapsed\u002FRefractory Multiple Myeloma (RRMM)","Inclusion Criteria:\n\n1. Must be able to understand and voluntarily sign an informed consent form (ICF).\n2. Must be ≥ 18 years of age at the time of signing the ICF.\n3. Must be able to adhere to the study visit schedule and other protocol requirements.\n4. Documented diagnosis of MM and must have:\n\n   (Part 1) relapsed and refractory disease having previously received 2 or more prior lines and having previously received lenalidomide, a proteosome inhibitor and\u002For anti-CD38 mAb (triple class exposed) and must be refractory to the last line of therapy.\n\n   (Part 2) relapsed disease having previously received 1-3 prior line of therapy including lenalidomide, a proteosome inhibitor, and\u002For an anti-CD38 mAb .\n   * Lines of therapy are defined as per the consensus panel of the International Myeloma Workshop and include induction therapy followed by ASCT and consolidation\u002Fmaintenance as one line.\n   * Relapse is defined as documented evidence of progressive disease (PD) after achieving at least stable disease (SD) for ≥ 1 cycle during a previous MM treatment (i.e., relapsed MM). and refractory is defined as disease progression during or within 60 days from the end of the most recent MM treatment.\n5. Subjects with measurable disease defined as at least one of the following (these baseline laboratory studies for determining eligibility must be obtained within 28 days prior to start of study drug):\n\n   1. Serum M-protein ≥ 5 g\u002Fl\n   2. Urine M-protein ≥ 200 mg\u002F24 h\n   3. Serum free light chains (FLC) assay: Involved FLC level ≥ 100 mg\u002Fl and an abnormal serum free light chain ratio (\\\u003C 0.26 or \\> 1.65).\n6. Subjects with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met:\n\n   \\- Transplant was \\> 100 days prior to study enrollment\n7. Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\n8. Adequate organ system function defined as:\n\n   1. Absolute neutrophil count (ANC) \\> 1.0 x 109\u002FL. Granulocyte colony-stimulating factor (G-CSF) cannot be given within 7 days prior to first study drug administration.\n   2. Hemoglobin ≥ 8.0 g\u002FdL.\n   3. Platelet count \\>75 x 109\u002FL.\n   4. Serum alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN).\n   5. Total bilirubin ≤ 1.5 x ULN, unless known to have Gilbert's disease. If Gilberts, isolated bilirubin \\>1.5 and \\\u003C3xULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C 35%.\n   6. Estimated glomerular filtration rate (eGFR) (MDRD) ≥ 30 mL\u002Fmin.\n   7. Albumin\u002Fcreatinine ratios (spot urine) \\\u003C500mg\u002Fg (56 mg\u002Fmmol).\n   8. Albumin ≥ 2.0 g\u002FdL (20 g\u002FL).\n   9. Left ventricular ejection fraction (LVEF) \\>50%.\n   10. Serum calcium (corrected for albumin) level ≤11.5 mg\u002FdL (treatment of hypercalcemia is allowed and patient may enroll if hypercalcemia returns to Grade ≤1 with standard treatment).\n9. All prior treatment-related toxicities must be Grade \\\u003C1 at the time of screening except for alopecia (any grade), neuropathy (Grade \\\u003C2), cataracts or endocrinopathy managed with replacement therapy (any grade).\n10. For women of childbearing potential and males: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.\n\nMale Participants:\n\nMale participants are eligible to participate if they agree to the following during the intervention period and for at 6 months after the last dose of study intervention to allow for clearance of any altered sperm:\n\n1. Refrain from donating sperm.\n\n   PLUS, either:\n2. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.\n\nOR c. Must agree to use contraception\u002Fbarrier as detailed below: d. 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 when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.\n\nFemale Participants:\n\nA female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\na. Is not a woman of childbearing potential (WOCBP). OR 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 and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the intervention period and for at least 5 months after the last dose of study intervention.\n\nA WOCBP must have a negative highly sensitive pregnancy test \\[serum\\] as required by local regulations) within 72 hours before the first dose of study intervention and agree to use effective contraception during the study and for 5 months after the last dose of cevostamab, 3 months after the last dose of tocilizumab and 4 months after the last dose of belamaf.\n\nExclusion Criteria:\n\n1. Prior treatment with bispecific or BCMA targeted antibody drug conjugate. Note prior anti-BCMA CAR T-cell therapy is permitted provided that the subject achieved a response of partial response (PR) or better and did not progress within 12 months of CAR T-cell infusion.\n2. Prior exposure to FcRH5 targeted therapy.\n3. Life-expectancy less than or equal to 12 weeks.\n4. WOCBP who are pregnant or lactating.\n5. Known history of amyloidosis, POEMS syndrome, active plasma cell leukemia (defined as circulating plasma cell count exceeding 500\u002FuL or 5% of the peripheral blood white cells) at the time of screening.\n6. Inability to comply with protocol-mandated hospitalization and activities restrictions.\n7. History of allogeneic stem cell transplant.\n8. Any serious and\u002For unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.\n9. Evidence of active mucosal or internal bleeding.\n10. Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety).\n11. Subjects with previous or concurrent malignancies are allowed only if the second tumor is not contributing to the subject's illness and deemed to be at negligible risk of metastasis or death (e.g., expected 5-year OS ≥90%). Examples include ductal carcinoma in situ not requiring chemotherapy, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, low-grade, localized prostate cancer (Gleason score ≤7) not requiring treatment or appropriately treated Stage I uterine cancer. Subjects must be appropriately observed or managed\u002Fcontrolled are permitted onto study. The subject must not be receiving active therapy, other than hormonal therapy for this disease and the disease must be considered medically stable for at least 2 years.\n12. Current corneal epithelial disease except mild punctate keratopathy.\n13. History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.\n\n    \\- Note that patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.\n14. Patients with history of confirmed progressive multifocal leukoencephalopathy (PML).\n15. Prior solid organ transplantation.\n16. Treatment with radiotherapy (with the exception of local, palliative radiotherapy for management of pain or for stabilization of an extensive bone lesion at risk of pathologic fracture or damage to surrounding tissue), any chemotherapeutic agent, or treatment with systemic therapy (systemic or biologic agent) 14 days. Prior treatment with a monoclonal antibody within 28 days of receiving the first dose of study drug.\n\n    Prior treatment with a monoclonal antibody, denosumab for hypercalcaemia is allowed.\n17. Use of an investigational drug within five half-lives or 28 days if the half-life of the investigational agent is unknown, preceding the first dose of study drug.\n18. Any major surgery within the last ≤ 4 weeks prior to initiating study treatment.\n19. Current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if participant otherwise meets entry criteria.\n20. Evidence of cardiovascular risk including any of the following:\n\n    1. Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobiz Type II) or 3rd degree atrioventricular (AV) block.\n    2. QTc interval ≥ 470 msecs. NOTE: The QT interval should be corrected for the heart rate by Fridericia's formula (QTcF)\n    3. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, stenting or bypass grafting, all within 6 months of Screening.\n    4. Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.\n    5. Uncontrolled hypertension\n21. Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM\n\n    * Note that patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator are allowed.\n    * Note that patients with a history of epilepsy who have had no seizures in the past 2 years while not receiving any anti-epileptic medications are allowed.\n22. Significant active pulmonary disease (e.g., bronchospasm and\u002For obstructive pulmonary disease)\n23. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belamaf and\u002For cevostamab any of the components of the study treatment. History of severe hypersensitivity to other mAbs.\n24. Known history of HLH\u002FIEH-HS or macrophage activation syndrome (MAS).\n25. Prior treatment with systemic immunotherapeutic agents, including, but not limited to cytokine therapy and anti-CTLA4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first dose of study drugs.\n26. Active infection requiring antibiotic, antiviral, or antifungal treatment.\n27. Known HIV infection.\n28. Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.\n29. Known or suspected chronic active Epstein-Bar Virus (EBV) infection. Guidelines for diagnosing chronic active EBV infection are provided by Okano et al. 2005.\n30. Presence of hepatitis B (HBV) surface antigen (HBsAg) or positive HBV PCR test at screening or within 3 months prior to first dose of study treatment. Participants with positive hepatitis B core antibody (HBcAb) can be enrolled, only if confirmatory negative Hepatitis B DNA is obtained AND patient is on hepatitis B prophylaxis (eg tenofovir or entecavir) before first dose of study drugs. Presence of isolated Hep B surface antigen (HBsAb) indicating previous vaccination will not exclude a participant.\n31. Positive hepatitis C (HCV) antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study 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.\n32. History of receiving systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), with the exception of corticosteroid treatment ≤10mg\u002Fday prednisone or equivalent within 2 weeks prior to first dose of study drugs.\n\n    1. The use of inhaled corticosteroids is permitted\n    2. The use of mineralocorticoids for management of orthostatic hypotension is permitted\n    3. The use of physiologic doses of corticosteroids for management of adrenal insufficiency is permitted however the dose should not exceed 10 mg prednisone a day.\n33. Intolerance to prednisone or dexamethasone that would preclude the patient from taking the full starting dose of dexamethasone or prednisone as described in the protocol.","ALL","18 Years","100 Years",{"count":20,"type":21},108,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study will evaluate efficacy and tolerability various doses of belantamab mafodotin in combination with cevostamab and pomalidomide in patients with multiple myeloma who have relapsed disease after two or more lines of therapy and\u002For have refractory to treatment disease.",[27],"Relapsed Refractory Multiple Myeloma (RRMM)",[29,30,31,32,33,34,35,36,37,38,39],"Multiple Myeloma Refractory","Multiple Myeloma Relapsed","belamaf","cevostamab","Belantamab Mafodotin","humanized IgG1 antibody-drug conjugate","humanized, full-length IgG1 anti-FcRH5\u002FCD3","Relapsed\u002FRefractory Multiple Myeloma","Myeloma","Multiple Myeloma","Blenrep","NOT_YET_RECRUITING","2026-09-15",{"date":43,"type":44},"2026-09-21","ACTUAL",{"date":46,"type":21},"2026-12",{"date":48,"type":21},"2033-03",{"name":50,"class":51},"Canadian Myeloma Research Group","OTHER",7,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":61,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":52},"100460223","phase-2-study-of-iberdomide-bortezomib-dexamethasone-with-isatuximab-added-on-demand-for-nd-nte-mm-patients-100460223","NCT05272826","Study of Iberdomide, Bortezomib, Dexamethasone With Isatuximab Added on Demand for ND-NTE MM Patients","A Single Arm, Response-adapted, Open Label Study of Iberdomide, Weekly Bortezomib and Dexamethasone (IberBd) With Isatuximab Added on Demand for Transplant-ineligible, Newly Diagnosed Multiple Myeloma Patients: the BOREALIS Trial","BOREALIS","Inclusion Criteria:\n\n1. Must understand and voluntarily sign informed consent form\n2. Age ≥ 65 years at the time of signing consent\n3. Must be able to adhere to the study visit schedule and other protocol requirements.\n4. Previously untreated, transplant ineligible, symptomatic multiple myeloma as defined by the criteria below.\n\n   Both criteria a and b must be met:\n   1. Clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma\n   2. Any one or more of the following myeloma defining events (MDE):\n\n   I. Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: i.Hypercalcemia: serum calcium \\>0.25 mmol\u002FL (\\>1 mg\u002FdL) higher than the upper limit of normal or \\>2.75 mmol\u002FL (\\>11 mg\u002FdL) ii. Renal insufficiency: creatinine clearance 177 μmol\u002FL (\\>2 mg\u002FdL) iii. Anemia: hemoglobin value of \\>2 g\u002FdL below the lower limit of normal, or a hemoglobin value \\\u003C10g\u002FdL iv. Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography-CT (PET-CT)\n\n   II. Biomarker criteria or MDE:\n\n   i. Clonal bone marrow plasma cell percentage ≥ 60% ii. Involved: uninvolved serum free light chain (FLC) ratio ≥100 (involved FLC level must be ≥100 mg\u002FL) iii. \\> 1 focal lesions on magnetic resonance imaging (MRI) studies (at least 5 mm in size)\n5. Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\n6. Females of child-bearing potential (FCBP) must have a negative serum test and follow the guidelines in the pregnancy prevention program. FCBP and males must either commit to continued abstinence from heterosexual intercourse or must abide by birth control requirements as described in Appendix 9 for the pregnancy prevention program.\n7. Men must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy as described in Appendix 9 of the pregnancy prevention program.\n8. Life expectancy of ≥ 3 months.\n9. Able to take oral medications.\n10. The following laboratory results must be met within 10 days prior to first study drug administration:\n\n    1. Absolute neutrophil count (ANC) ≥ 1.0 x 109\u002FL. Growth factors cannot be given within 10 days of study drug administration.\n    2. Serum AST and ALT ≤ 1.5 x upper limit of normal (ULN).\n    3. Creatinine clearance ≥ 30 mL\u002Fmin either directly measured via 24-hour urine collection or calculated using MDRD (Appendix 1).\n    4. Platelet count ≥ 50 x 109\u002FL. Platelet transfusions to help subjects meet eligibility criteria are not allowed within 10 days before study enrollment.\n    5. Hemoglobin ≥ 80 g\u002FL.\n\nExclusion Criteria:\n\n1. Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid \\[i.e. less than or equal to the equivalent of dexamethasone 40 mg\u002Fday for 4 days; such a short course of steroid treatment must not have been given within 14 days of treatment start\\]).\n2. Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.\n3. Pregnant or lactating females.\n4. Renal failure requiring hemodialysis or peritoneal dialysis.\n5. Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:\n\n   1. Basal cell carcinoma of the skin\n   2. Squamous cell carcinoma of the skin\n   3. Carcinoma in situ of the cervix\n   4. Carcinoma in situ of the breast\n   5. Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)\n6. Patients who are unable or unwilling to undergo antithrombotic therapy.\n7. Peripheral neuropathy of ≥ grade 2 severity.\n8. Known HIV positivity or active infectious hepatitis, type A, B, or C.\n9. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.\n10. Plasma Cell Leukemia\n11. Evidence of cardiovascular risk including any of the following:\n\n    1. QTc interval ≥ 470 msecs. Note that the QT interval should be corrected for heart rate by Fridericia's formula (QTcF)\n    2. Evidence of current clinically significant uncontrolled arrhythmias; including clinically significant ECG abnormalities; including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block.\n    3. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within six months of screening.\n    4. Class III or IV heart failure as defined by the New York Heart Association functional classification system (Appendix 2)\n    5. Uncontrolled hypertension\n12. Patients with hypersensitivity to boron or any of its excipients or to the active substance of Iberdomide or its excipients\n13. Patients requiring strong inhibitors or inducers of CYP3A4\u002F5. See Appendix 10 for a list of these drugs\n14. Any concurrent severe and\u002For uncontrolled medical condition or psychiatric disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study or that confounds the ability to interpret data from the study.\n15. Patients that have had severe acute respiratory syndrome coronavirus 2 infection within 14 days for mild or asymptomatic infections or 28 days for severe\u002Fcritical illness prior to initiating study treatment.\n16. Patients that have undergone major surgery (as defined by the investigator) within 28 days of initiating study treatment.\n17. Active systemic infection that is likely to interfere with the study procedures or results or that, in the opinion of the investigator, would constitute a hazard for participating in this study.\n18. Patients with a gastrointestinal disease that may significantly alter the absorption of iberdomide\n19. Patients that have received a live vaccine within 3 months of initiating study treatment.","65 Years",{"count":63,"type":21},75,[65],"PHASE2","This study will evaluate efficacy and tolerability of iberdomide, bortezomib, dexamethasone and isatuximab on demand administered in combination for newly diagnosed transplant-ineligible multiple myeloma patients.",[38],"RECRUITING","2026-08-27",{"date":71,"type":44},"2026-08-31",{"date":73,"type":44},"2024-12-12",{"date":75,"type":21},"2031-03",{"name":50,"class":51},""]