A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared with the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants with Relapsed/Refractory Multiple Myeloma (DREAMM 7)

GlaxoSmithKline K.K.0 个研究点目标入组 478 人开始时间: 2021年7月5日最近更新: 2023年2月28日

适应症

试验速览

暂无简介。

•Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria.
•Previously treated with at least 1 prior line of multiple myeloma (MM) therapy, and must have documented disease progression during or after their most recent therapy.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
•Must have at least 1 aspect of measurable disease, defined as one of the following;
•Urine M-protein excretion >=200 mg per 24-hour, or
•Serum M-protein concentration >=0.5 grams per deciliter (g/dL), or
•Serum free light chain (FLC) assay: involved FLC level >=10 mg per dL (>=100 mg per liter) and an abnormal serum free light chain ratio (<0.26 or >1.65).
•All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be <=Grade 1 at the time of enrollment, except for alopecia.
•Adequate organ function

•Intolerant to daratumumab.
•Refractory to daratumumab or any other anti-CD38 therapy (defined as progressive disease during treatment with anti-CD38 therapy, or within 60 days of completing that treatment).
•Intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m^2 twice weekly, or within 60 days of completing that treatment). Note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed.
•Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.
•Prior treatment with anti-B-cell maturation antigen (anti-BCMA) therapy.
•Prior allogenic stem cell transplant.
•Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies.
•Corneal epithelial disease.

Progression-free survival

时间窗: Up to an average of 34 months

Time from start of study treatment to the first documented disease progression or death due to any cause, whichever occurs first.

未报告次要终点

发起方

GlaxoSmithKline K.K.