CTRI/2024/03/064587
尚未招募
1 期
A Phase 1, Randomized, Dose and Schedule Evaluation Study toInvestigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity ofBelantamab Mafodotin Administered in Combination with Standard of Care inParticipants with Newly Diagnosed Multiple Myeloma - DREAMM-9
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Health Condition 1: C900- Multiple myeloma
- 发起方
- GlaxoSmithKline Research Development Limited
- 状态
- 尚未招募
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Participant must be over 18 years of age inclusive, at the time of signing the informed
- •Type of Participant and Disease Characteristics
- •2\. Diagnosis of multiple myeloma with a requirement for treatment as documented per
- •International Myeloma Working Group (IMWG) criteria \[Rajkumar, 2014].
- •a. Urine M\-protein excretion \=200 mg/24 hrs (\=0\.2g/24 hrs), 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\).
- •3\. Not a candidate for high\-dose chemotherapy with ASCT due to presence of
- •significant comorbid condition(s), such as cardiac, pulmonary or other major organ
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Type of Participant and Disease Characteristics
- •1\. Smoldering multiple myeloma (SMM).
- •2\. Prior systemic therapy for multiple myeloma, or SMM.
- •3\. Participant is eligible for high dose chemotherapy with ASCT, as determined by a
- •frailty score of 0 as assessed by the IMWG frailty index.
- •Medical Conditions
- •4\. Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the NCICTCAE
- •Version 5\.
- •5\. Major surgery within 4 weeks prior to the first dose of study drug.
结局指标
主要结局
未指定
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