A phase 1/2, dose and schedule evaluation study to investigate the safety and clinical activity of Belantamab Mafodotin administered in combination with Daratumumab, Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma transplant ineligible.

Hellenic Society of Hematology (EAE)0 个研究点目标入组 36 人开始时间: 2022年2月4日最近更新: 2022年3月14日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 36

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1.Age = 18 years
•2.Monoclonal plasma cells in the BM =10% or presence of a biopsy proven plasmacytoma and documented MM satisfying at least 1 of the
•CRAB criteria: -Hypercalcemia:serum calcium >0.25 mmol/L higher than ULN or >2.75 mmol/L. - Renal insufficiency:CrCl <40mL/min or serum creatinine >177 µmol/L. -Anemia: hemoglobin >2 g/dL below the lower limit of normal or hemoglobin <10 g/dL. - Bone lesions: 1 or more osteolytic lesions on skeletal radiography, CT or PET-CT OR
•Biomarkers of Malignancy: - Clonal BM plasma cell =60% - Involved: uninvolved serum FLC ratio =100 - More than 1 focal lesion on MRI studies 3.Must have at least 1 aspect of measurable disease, defined as one of the below Urine M-protein excretion =200 mg/24 hours or
•Serum M-protein concentration =0.5 g/dL or Serum FLC assay: involved FLC level =10 mg/dL and an abnormal serum FLC ratio <0.26 or >1.65
•4.Not a candidate for high-dose chemotherapy with ASCT due to the presence of significant comorbid condition(s) that are likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation. The participants will be assessed by the IMWG frailty index that is recommended by ESMO guidelines. Participants with IMWG frailty index score 1 or 2 will be considered transplant ineligible
•5.ECOG performance status: 0–2
•6.Adequate organ system function as defined by the below laboratory assessments.
•oANC =1.25 X 109/L; GCSF use within the past 14 days is NOT permitted
•Hemoglobin = 8.0 g/dL; transfusions within the past 14 days are NOT permitted
•PLT = 50 x 109/L if BM is >50% involved in myeloma. Otherwise =75 x 109/L; transfusions within the past 14 days are NOT allowed to reach this level
•Total bilirubin =1.5xULN
•ALT = 2.5xULN
•eGFR =30 mL/min/1.73 m2
•Spot urine < 500 mg/g (56 mg/mmol) OR
•Urine Dipstick: Negative trace; if = 1+ only eligible if confirmed < 500 mg/g [56 mg/mmol] by albumin/creatinine ratio
•7.Female participants are eligible to participate if she is not pregnant or breastfeeding and at least 1 of the following conditions applies:
•Is not a WOCBP defined as follows:
•a.Age= 45 years with no menses for > 1 year
•b.Participants who have been amenorrhoeic for < 2 years without a history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
•c.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
•Is a WOCBP and using 2 methods of reliable birth control, beginning 4 weeks before initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide treatment. Thereafter, WOCBP must use 1 method of reliable birth control that is highly effective for a further 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 lenalidomide or 3 months following discontinuation of daratumumab treatment or 4 months following discontinuation of belantamab mafodotin treatment whichever is longer.
•A WOCBP must have 2 negative pregnan

排除标准

•1.Prior systemic therapy for MM or SMM.
•2.Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the NCI CTCAE Version 5.
•3.Major surgery within 2 weeks before the first dose of study drug
•4.Presence of active renal condition. Participants with isolated proteinuria resulting from MM are eligible, provided that they fulfil the other inclusion criteria.
•5.Any serious and/or 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.
•6.Evidence of active mucosal or internal bleeding uncontrolled by local therapy and not explained by reversible coagulopathy.
•7.Current active unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
•8.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.
•9.Evidence of cardiovascular risk including any of the following:
•Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities, second degree or third degree AV block.
•Screening 12-lead ECG showing a baseline QT interval >470 msec
•History of myocardial infarction, acute coronary syndromes, coronary angioplasty or stenting or bypass grafting within 3 months of Screening.
•Class III or IV heart failure as defined by the New York Heart Association functional classification system.
•Uncontrolled hypertension.
•10.Participant has known COPD
•11.Active infection requiring treatment.
•12.Known HIV infection, unless the participant can meet all of the following criteria:
•Established ART for at least 4 weeks and HIV viral load <400 copies/mL.
•CD4+ T-cell (CD4+) count =350 cells/uL.
•No history of AIDS-defining opportunistic infections within the last 12 months.
•13.To be seropositive for hepatitis B at screening or within 3 months prior to first dose of study treatment.
•14.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:
•RNA test negative
•Successful anti-viral treatment is required, followed by a negative HCV RNA test after a washout period of at least 4 weeks.
•15.Current corneal epithelial disease except for mild punctate keratopathy.
•16.Intolerance or contraindications to anti-viral prophylaxis.
•17.Unable to tolerate antithrombotic prophylaxis.
•18.Active or history of venous thromboembolism within past 3 months.
•19.AL amyloidosis (light chain amyloidosis), active POEMS syndrome or active plasma cell leukemia at the time of screening.
•20.Exhibiting clinical signs of or with a known history of meningeal or central nervous system involvement by MM.
•21.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 SC or to any of its excipients; or infused protein products, sucrose, histidine, and polysorbate 80.

研究者

发起方

Hellenic Society of Hematology (EAE)

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