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)

GlaxoSmithKline Research & Development Limited0 个研究点目标入组 300 人开始时间: 2020年6月29日最近更新: 2024年7月29日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: GlaxoSmithKline Research & Development Limited
入组人数: 300

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

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 treated with lenalidomide .10 mg daily for at least 2 consecutive cycles are eligible. 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 (ASCT) or are considered transplant ineligible. Participants with a history of ASCT are eligible for study participation provided the following eligibility criteria are met:
•a.ASCT 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 Terminology 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
•10.Female Participants:
•Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
•A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
•Is not a woman of childbearing potential (WOCBP)
•Due to pomalidomide being a thalidomide analogue with a risk for embryofetal toxicity and prescribed under a pregnancy prevention/controlled distribution programme, WOCBP participants will be eligible if they commit either to abstain continuously from heterosexual sexual intercourse or use two methods of reliable birth control (one method that is highly effective plus an additional barrier method), beginning 4 weeks prior to initiating treatment with pomalidomide, during therapy, during dose interruptions and continuing for at least 4 weeks following discontinuation of pomalidomide treatment. Thereafter, WOCBP participants must use one contraceptive method that is highly effective (with a failure rate of <1% per year) for a further 3 months for WOCBP in Arm A, and 6 months for WOCBP in Arm B.
•All WOCBP must agree 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 relat

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.
•NOTE: Participants who have undergone syngeneic transplant will be allowed only if no history of or no currently active graft versus host disease (GvHD).
•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 an anti-MM 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 (NYHA) 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.
•NOTE: Stable non-cirrhotic chronic liver disease (including Gilbert’s syndrome or asymptomatic gallstones) is acceptable if participant otherwise meets entry criteria).
•14.Active infection requiring treatment.
•15.Known human immunodeficiency virus (HIV) infection unless the participant can meet all of the following criteria:
•Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load <400 copies/mL
•CD4+ T-cell (CD4+) counts =350 cells/mL
•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 /or overlapping toxicities with belantamab mafodotin or other combination products as relevant
•16.Patients with hepatitis B will be excluded unless the criteria listed in protocol are met
•17.Positive

研究者

发起方

GlaxoSmithKline Research & Development Limited

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