JPRN-jRCT2061230056尚未招募1 期
A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) - DREAMM 5 - DREAMM 5
Ishibashi Hideyasu0 个研究点目标入组 464 人开始时间: 2023年9月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 464
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
- 年龄范围
- >= 18age old 至 ot applicable（—）
入选标准
- •Participant must be 18 years of age inclusive or older, at the time of signing the informed consent.
- •-Participants must have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the IMWG.
- •-Participants having at least 3 prior lines of prior anti-myeloma treatments including an immunodilating agent (IMID) a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
- •-Participants with a history of autologous stem cell transplant are eligible for study participation when, transplant was >100 days prior to study enrolment and with no active infection(s).
- •-Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, unless ECOG less than equal to (<=)2 is due solely to skeletal complications and/or skeletal pain due to MM.
- •-Participants with measurable disease defined as at least one of the following: Serum M-protein greater than equal to (>=)0.5 gram per deciliter (>=5 gram per liter) or Urine M-protein >=200 mg per 24 hours or Serum free light chain (FLC) assay: Involved FLC level >=10 mg per deciliter (>=100 mg per Liter) and an abnormal serum FLC ratio (<0.26 or >1.65).
- •-Participants who have tested positive for Hepatitis B core antibody (HBcAb) can be enrolled if the following criteria are met: Serology result HBcAb+, Hepatitis B surface antigen (HBsAg)-; HBV DNA undetectable during screening.
- •-Participants who are currently receiving physiological doses oral steroids (<10 mg/day), inhaled steroids or ophthalmalogical steroids.
排除标准
- •-Participants with current corneal epithelial disease except mild punctate keratopathy.
- •-Participants with evidence of cardiovascular risk
- •-Participants with known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin or any of the components of the study treatment. History of severe hypersensitivity to other mAb.
- •-Participants with active infection requiring antibiotic, antiviral, or antifungal treatment.
- •-Participants with other monoclonal antibodies within 30 days or systemic anti-myeloma therapy within <14 days.
- •-Participants with prior radiotherapy within 2 weeks of start of study therapy.
- •-Participants with prior allogeneic transplant are prohibited.
- •-Participants who have received prior Chimeric Antigen T cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening.
- •-Participants with any major surgery (other than bone-stabilizing surgery) within the last 30 days.
- •-Participants with prior treatment with an investigational agent within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is shorter.
- •-Participants with >=grade 3 toxicity considered related to prior check-point inhibitors and that led to treatment discontinuation.
- •-Participants who have received transfusion of blood products within 2 weeks before the first dose of study drug.
- •-Participants must not receive live attenuated vaccines within 30 days prior to first dose of study treatment or whilst receiving belantamab mafodotin +- partner agent in any sub-study arm of the platform trial and for at least 70 days following last study treatment.
- •-Participants with presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM.
研究者
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