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多发性骨髓瘤的下一代疗法:利用 ClinicalTrials.gov 评估正在进行的临床试验。

The next generation of therapy for multiple myeloma: a review of ongoing clinical trials utilizing ClinicalTrials.gov.

机构信息

Department of Medicine, Division of Hematology/Oncology, Warren Alpert Medical School of Brown University, Providence, RI 02903, USA.

Division of Hematology/Oncology, Lifespan Cancer Institute, Providence, RI 02903, USA.

出版信息

Future Oncol. 2018 Aug;14(19):1965-1976. doi: 10.2217/fon-2017-0722. Epub 2018 Jul 18.

DOI:10.2217/fon-2017-0722
PMID:30019947
Abstract

The therapeutic armamentarium for multiple myeloma has grown significantly over the past decade. We characterized ongoing multiple myeloma clinical trials utilizing ClinicalTrials.gov . A search of ClinicalTrials.gov on 21 April 2017 returned 239 therapeutic interventional trials in multiple myeloma. A majority (84.1%) of trials are early-phase (I/II). Immunotherapies are significantly more likely to be studied in Phase I trials than Phase II trials (p = 0.0049). Primary sponsor (academic, cooperative group, industry) is significantly associated with phase of trial (p = 0.0334). Quality of life assessment is included as a secondary objective in only 10.1% of trials. Areas of need are continued advancement of immunotherapies, late-phase studies utilizing a triplet control group, and an objective focus on quality of life.

摘要

过去十年中,多发性骨髓瘤的治疗方法有了显著的发展。我们利用 ClinicalTrials.gov 对正在进行的多发性骨髓瘤临床试验进行了描述。2017 年 4 月 21 日,在 ClinicalTrials.gov 上进行了搜索,共返回 239 项多发性骨髓瘤治疗干预试验。大多数(84.1%)试验处于早期阶段(I/II 期)。与 II 期试验相比,免疫疗法更有可能在 I 期试验中进行研究(p=0.0049)。主要赞助商(学术机构、合作组、工业界)与试验阶段显著相关(p=0.0334)。仅 10.1%的试验将生活质量评估作为次要目标。需要继续推进免疫疗法的发展,开展采用三联对照组的后期研究,并将重点放在生活质量上。

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