A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination with Pomalidomide and Dexamethasone (B-Pd) versus Pomalidomide plus Bortezomib and Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma (DREAMM 8) - DREAMM-8 (ACRONYM)

GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT0 个研究点目标入组 284 人开始时间: 2020年10月21日最近更新: 2020年12月7日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 284

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

•Participants are eligible to be included in the study only if all of the following criteria are met:
•1.Capable of giving signed informed consent as described in Section 10.1.3, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
•2.Male or female, 18 years or older (at the time consent is obtained).
•3.Have a confirmed diagnosis of multiple myeloma as defined by the IMWG criteria [Rajkumar, 2016].
•4.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Section 10.6).
•5.Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen (lenalidomide must have been administered for at least 2 consecutive cycles) and must have documented disease progression during or after their most recent therapy.
•Note: Participants intolerant or refractory to bortezomib at 1.3 mg/m2 dose twice weekly dosing schedule are not eligible.
•6.Must have at least ONE aspect of measurable disease, defined as one the following:
•a.Urine M-protein excretion =200 mg/24 h, or
•b.Serum M-protein concentration =0.5 g/dL (=5.0 g/L), or
•c.Serum free light chain (FLC) assay: involved FLC level =10 mg/dL (=100 mg/L) and an abnormal serum free light chain ratio (<0.26 or >1.65) only if patient has no measurable urine or serum M spike.
•7.Have undergone autologous stem cell transplant (SCT) or are considered transplant ineligible. Participants with a history of autologous SCT are eligible for study participation provided the following eligibility criteria are met:
•a.Autologous SCT was >100 days prior to the first dose of study medication
•b.No active bacterial, viral, or fungal infection(s) present
•8.All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE] v5.0) must be =Grade 1 at the time of enrolment, except for alopecia.
•9.Adequate organ system functions as defined by the laboratory assessments listed in the protocol
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 165
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 285

排除标准

•A participant will not be eligible for inclusion in this study if any of the following criteria are met:
•1.Active plasma cell leukemia at the time of screening. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes).
•2.Participants after prior allogeneic SCT.
•3.Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) or use of an investigational drug within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; Prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs.
•4.Plasmapheresis within 7 days prior to the first dose of study drug.
•5.Received prior treatment with or intolerant to pomalidomide.
•6.Received prior BCMA targeted therapy.
•7.Intolerant to bortezomib or refractory to bortezomib (i.e., participant experienced progressive disease during treatment, or within 60 days of completing treatment, with a bortezomib-containing regimen of 1.3 mg/m2 twice weekly).
•8.Evidence of cardiovascular risk including any of the following:
•a.Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities including 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.
•b.History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening.
•c.Class III or IV heart failure as defined by the New York Heart Association functional classification system (Section 10.8)
•d. Uncontrolled hypertension.
•9.Any major surgery within the last 4 weeks.
•10.Previous or concurrent invasive malignancy other than multiple myeloma, except:
•The disease must be considered medically stable for at least 2 years; or
•The participant must not be receiving active therapy, other than hormonal therapy for this disease.
•11.Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
•12.Evidence of active mucosal or internal bleeding.
•13.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.
•14.Active infection requiring treatment.
•15.Known human immunodeficiency virus (HIV) infection.
•16.Presence of hepatitis B surface antigen (HbsAg), or hepatitis B core antibody (HbcAb) at Screening or within 3 months prior to first dose of study treatment).
•17.Positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment.
•18.Intolerance or contraindications to anti-viral prophylaxis.
•19.Presence of active renal conditions (e.g. infection, severe renal impairment requiring dialysis or any other condition that could affect participant’s safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfil criteria given in Table 4.
•20.Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.
•21.Active or history of venous thromboembolism within the past 3 months.
•22.Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophy

研究者

发起方

GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT

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