达雷妥尤单抗(Daratumumab) - 药物靶点：CD38_在研适应症：免疫球蛋白轻链淀粉样变性，多发性骨髓瘤，残留肿瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Daratumumab (Genetical Recombination)、达雷木单抗、JNJ-54767414

+ [4]

靶点

CD38

作用机制

CD38抑制剂(淋巴细胞分化抗原CD38抑制剂)、ADCC(抗体依赖的细胞毒作用)、抗体依赖的细胞吞噬作用

治疗领域

癌症免疫系统疾病心血管疾病+ [6]

在研适应症

免疫球蛋白轻链淀粉样变性多发性骨髓瘤残留肿瘤+ [17]

非在研适应症

结外NK-T细胞淋巴瘤滤泡性淋巴瘤难治性套细胞淋巴瘤+ [7]

原研机构

Janssen Global Services LLC

在研机构

Janssen Scientific Affairs LLCJanssen Research & Development LLCJanssen-Cilag International NV

+ [12]

非在研机构

Janssen-Cilag GmbH

Genentech, Inc.

最高研发阶段批准上市

首次获批日期

美国 (2015-11-16),

多发性骨髓瘤

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、快速通道 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、附条件批准 (中国)、孤儿药 (日本)、孤儿药 (韩国)、儿科研究计划 (欧盟)、孤儿药 (英国)、优先审评 (日本)

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序列信息

Sequence Code 9075449L

来源: *****

Sequence Code 9946743H

来源: *****

关联

297

项与达雷妥尤单抗相关的临床试验

NCT06287944 / Not yet recruiting临床1期

Phase I Study of Escalating Doses of 225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody Added to the Conditioning Regimen of Fludarabine, Melphalan and Organ Sparing Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome

This phase I trial tests the safety, side effects, best dose, and effectiveness of 225Ac-DOTA-Anti-CD38 daratumumab monoclonal antibody in combination with fludarabine, melphalan and total marrow and lymphoid irradiation (TMLI) as conditioning treatment for donor stem cell transplant in patients with high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Radioimmunotherapy is treatment with a radioactive substance that is linked to a monoclonal antibody, such as daratumumab, that will find and attach to cancer cells. Radiation given off by the radioisotope my help kill the cancer cells. Chemotherapy drugs, such as fludarabine and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TMLI is a targeted form of body radiation that targets marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize therapy effect. Actinium Ac 225-DOTA-daratumumab combined with fludarabine, melphalan and TMLI may be safe, tolerable, and/or effective as conditioning treatment for donor stem cell transplant in patients with high-risk AML, ALL, and MDS.

开始日期2024-10-18

申办/合作机构

Hope Medical Center

[+1]

NCT06046287 / Recruiting临床2期IIT

Phase IIa Study to Evaluate Daratumumab for Polyneuropathy Associated With MGUS

The goal of this clinical trial is to learn about daratumumab and hyaluronidase-fihj in patients with monoclonal gammopathy of undetermined significant (MGUS) who have been diagnosed with peripheral neuropathy suspected to be cause by paraproteinemia. The main question[s] it aims to answer are:
• how well does this medication help improve MGUS associated peripheral neuropathy
Participants will be asked be asked to get some testing done prior to starting the trial in order for us to assess your nerve damage or peripheral neuropathy. This will include blood tests, a complete neurologic examination, surveys and tests called electromyogram and nerve conduction studies. Participants that qualify for the trial will take DARZALEX FASPRO® once a week for two months, followed by every other week from months 3 to month 6.

开始日期2024-10-01

申办/合作机构

Georgetown University

[+1]

NCT06574126 / Not yet recruiting临床2期IIT

Phase II Open-Label, Single Arm, Multicenter Study of Ciltacabtagene Autoleucel in High-Risk Smoldering Multiple Myeloma (GEM-CAR-HiRiSMM)

This is an open-label, single arm, multicenter, interventional study with Dara-VRD followed by cilta-cel in high-risk smoldering multiple myeloma (SMM) patients.
The primary objectives of this trial, related with efficafy and safety of the treatment, are i) to evaluate the proportion of high-risk SMM patients with undetectable minimal residual disease (MRD) at 6 months, 12 months, and thereafter every 12 months up to 5 years after cilta-cel administration as well as the sustained undetectable MRD rate in the intent-to-treat (ITT) population; ii) to annotate frequency and severity of adverse events (AE) and serious adverse events (SAE), as well as data from laboratory tests aslo related with safety such as Immunoglobulin (Ig) G levels, complete blood count (CBC) cytopenia adn T-cell populations. Secondary objectives are related with response to therapy and will measure different categories of response and survival.

开始日期2024-09-30

申办/合作机构-

100 项与达雷妥尤单抗相关的临床结果

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100 项与达雷妥尤单抗相关的转化医学

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100 项与达雷妥尤单抗相关的专利（医药）

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1,459

项与达雷妥尤单抗相关的文献（医药）

2024-05-01·American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons

Immunotactoid hepatopathy: A novel entity with histologically proven recurrence post liver transplantation

作者: Olevian, Dane C ; Herlitz, Leal ; Bakhshwin, Ahmed ; El Hag, Mohamed I ; Friedman, Kenneth ; Mehdi, Ali ; Esfeh, Jamak Modaresi ; Hashimoto, Koji ; Eghtesad, Bijan ; Raza, Shahzad ; Hu, Shaomin

Immunotactoid deposition is a rare fibrillary deposition disease that is primarily seen in the kidney and is associated with paraproteinemia. Here, we report a case of hepatic immunotactoid deposition in a 67-year-old male with a history of smoldering myeloma and chronic kidney disease who underwent liver transplantation for metabolic dysfunction-related cirrhosis. Immunotactoid deposition was first identified in the explanted liver and recurred in the allograft within only 7 weeks following transplantation, presenting as ascites with normal liver function tests. The patient's posttransplant course was complicated by proteinuria and renal failure requiring dialysis. Histologic examination of both native and allograft livers demonstrated pink amorphous material occupying sinusoidal spaces that were Congo-red negative and immunoglobulin M Kappa-restricted. Electron microscopy revealed characteristic deposits of electron-dense bundles of hollow microtubules with a 40 nm diameter within the sinusoids and space of Disse, consistent with immunotactoids. Therapy of the patient's underlying plasma-cell dyscrasia utilizing a daratumumab-based regimen showed decreased serum paraproteins, resolution of ascites, and improved kidney function, no longer requiring dialysis, without inducing rejection. The patient continues to respond to treatment 10 months posttransplant.

2024-05-01·European journal of haematology

Real‐world treatment patterns in patients initiating third‐line therapy for relapsed or refractory multiple myeloma in Germany, Italy, the United Kingdom, France, and Spain

Article

作者: Perera, Sue ; Hanna, Maya ; Maywald, Ulf ; Lehne, Moritz ; Ramasamy, Karthik ; d'Estrubé, Tim ; Shukla, Soham ; Zhuleku, Evi ; Kortüm, K Martin ; Kellermann, Lenka ; Wilke, Thomas ; Ghiani, Marco ; Zamagni, Elena

Abstract:

Objectives:

To retrospectively analyze real‐world treatment patterns in patients with relapsed/refractory multiple myeloma (RRMM) who initiated third‐line treatment in Europe.

Methods:

German and Italian administrative claims data were sourced from the German AOK PLUS health insurance fund and Italian local health units (2016–2020). Data for the United Kingdom (UK), France, and Spain were sourced from medical chart reviews (MCRs) from 2016 to 2018 (historical) and 2019 to 2021 (new) using electronic case report forms.

Results:

Across all countries, immunomodulatory imide drug (IMiD)‐based regimens were prominent in the third‐line setting. From 2016 to 2020, lenalidomide‐dexamethasone was most common in Italy (18.0%) and Germany (12.7%). From 2019 to 2021, the most common regimen was ixazomib‐lenalidomide‐dexamethasone (67.5%) in the UK, pomalidomide‐dexamethasone (17.1%) in France, and daratumumab‐bortezomib‐dexamethasone (15.0%) in Spain.In the historical data (2016–2018), third‐line lenalidomide‐ and pomalidomide‐dexamethasone doublet use across the UK (>47%), France (>46%), and Spain (>33%) was high. From historical to new, triplet use increased in Spain (>19% to >60%) as did anti‐CD38 agent use in France (15.1% to 51.9%) and Spain (19.7% to 42.1%).

Conclusions:

From 2016 to 2021, third‐line regimens were mostly IMiD based. The MCR data demonstrated evolving treatment choices from 2016 to 2018 and 2019 to 2021, providing insights into uptake of novel agents and current RRMM European clinical practice.

2024-04-01·Hematology/oncology clinics of North America

Monoclonal Antibodies in the Treatment of Multiple Myeloma

Review

作者: Zweegman, Sonja ; van de Donk, Niels W C J

The incorporation of monoclonal antibodies into backbone regimens has substantially improved the clinical outcomes of patients with newly diagnosed and relapsed/refractory multiple myeloma (MM). Although the SLAMF7-targeting antibody elotuzumab has no single- agent activity, there is clinical synergy between elotuzumab and immunomodulatory drugs in patients with relapsed/refractory disease. Daratumumab and isatuximab are CD38-targeting antibodies which have single-agent activity and a favorable safety profile, which make these agents an attractive component of combination regimens. Monoclonal antibodies may cause infusion-related reactions, but with subcutaneous administration these are less frequently observed. All therapeutic antibodies may interfere with assessment of complete response. Next-generation Fc-engineered monoclonal antibodies are in development with the potential to further improve the outcome of patients with MM.

796

项与达雷妥尤单抗相关的新闻（医药）

2024-09-18

·Pharmaceutical Technology

MHLW accepts GSK’s multiple myeloma treatment NDA for review

The MHLW also granted orphan drug designation to Blenrep for multiple myeloma indication. Credit: CeltStudio/Shutterstock. Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted for review GSK ‘s new drug application (NDA) for Blenrep (belantamab mafodotin) to treat patients with relapsed or refractory multiple myeloma. The NDA includes a combination of Blenrep with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex). The MHLW also granted orphan drug designation to Blenrep for multiple myeloma indications, ensuring a priority review. This is the third major acceptance for belantamab mafodotin combinations, after the marketing authorisation application acceptance by the European Medicines Agency and the UK’s Medicines and Healthcare products Regulatory Agency. The latest application is supported by interim data from the DREAMM-7 and DREAMM-8 Phase III clinical trials. See Also: Japan approves updated Covid-19 vaccine to tackle JN.1 variant Into the unknown: How quickly can vaccines be developed for Disease X In the DREAMM-7 trial, belantamab mafodotin combined with BorDex was evaluated against daratumumab plus BorDex. The DREAMM-8 trial compared belantamab mafodotin with PomDex against bortezomib plus PomDex. These trials met their primary endpoints, demonstrating significant improvements in progression-free survival with the Blenrep combinations compared to standard care. Although the overall survival (OS) trend was positive, it was not statistically significant at interim analysis, with further follow-up for OS ongoing. Both trials also reported improvements across all secondary efficacy endpoints, including deeper and more durable responses. The safety and tolerability profiles of the belantamab mafodotin combinations in both trials were in line with those of the individual agents. Blenrep is an antibody-drug conjugate that targets the B-cell maturation antigen. GSK research and development oncology global head and senior vice-president Hesham Abdullah stated: “Blenrep combinations show potential based on the results of the DREAMM-7 and DREAMM-8 trials to redefine the treatment of relapsed/refractory multiple myeloma. “We are committed to working with health authorities worldwide to advance Blenrep along regulatory pathways so we can bring these additional treatment options to patients as quickly as possible.” In August 2024, the MHLW approved GSK’s Nucala (mepolizumab) for the treatment of adults with chronic rhinosinusitis with nasal polyps whose condition is inadequately controlled with standard therapy.

临床结果临床3期上市批准孤儿药申请上市

2024-09-16

·Pharmaceutical Technology

China grants BTD to Blenrep with BorDex for multiple myeloma

30,000 new cases of multiple myeloma are diagnosed each year in China. Credit: luchschenF/Shutterstock. China’s National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted breakthrough therapy designation (BTD) for GSK ‘s Blenrep (belantamab mafodotin) combined with bortezomib plus dexamethasone (BorDex) for the treatment of relapsed or refractory multiple myeloma. The BTD aims to accelerate the development of treatments for severe and life-threatening diseases where there is a lack of existing treatments or where preliminary evidence indicates an improvement in patient outcomes over current treatment options. GSK research and development global head for oncology, senior vice-president Hesham Abdullah stated: “Breakthrough therapy designation in China underscores the potential for Blenrep to redefine outcomes for patients with multiple myeloma at or after their first relapse. “We look forward to continuing to work with the health authority in China and others worldwide to bring Blenrep-based combinations to patients as expeditiously as possible.” The BTD was granted based on the interim results of the Phase III DREAMM-7 trial, which met its primary endpoint. See Also: Regeneron’s Dupixent approved as first adolescent CRSwNP treatment Lilly’s EBGLYSS gains FDA approval for patients aged 12 and older The trial showed statistically significant and clinically meaningful improvements in progression-free survival (PFS) for belantamab mafodotin along with BorDex as against daratumumab plus BorDex in relapsed or refractory multiple myeloma. At the time of the interim analysis, a positive overall survival (OS) trend was seen, although it was not statistically significant. Follow-up for OS is continuing. The results also indicated clinically meaningful improvements across all other secondary efficacy endpoints as against the standard of care combination. Key secondary endpoints include OS, duration of response and minimal residual disease negativity rate as evaluated by next-generation sequencing. Other secondary endpoints include overall response rate, safety and quality of life outcomes. In the DREAMM-7 trial, the safety and tolerability profile of the belantamab mafodotin combination was in line with the known profiles of the individual agents. The DREAMM-7 Phase III clinical trial is a multicentre, open-label, randomised study analysing the efficacy and safety of belantamab mafodotin in combination with BorDex as against a combination of daratumumab and BorDex in patients with relapsed/refractory multiple myeloma who previously received at least one previous line of multiple myeloma treatment, with disease progression recorded during or after their most recent therapy. For the trial, a total of 494 participants were randomised at a 1:1 ratio to receive either belantamab mafodotin in combination with BorDex or a combination of daratumumab and BorDex. Every three weeks, belantamab mafodotin was administered at 2.5mg/kg intravenously. An antibody-drug conjugate, Blenrep consists of a humanised B-cell maturation antigen monoclonal antibody conjugated to the cytotoxic agent auristatin F through a non-cleavable linker. The drug linker technology is licensed from Seagen , while the monoclonal antibody is produced using Potelligent Technology licensed from BioWa, a member of the Kyowa Kirin Group. Blenrep is approved as a monotherapy in Hong Kong, Israel and Singapore. Multiple myeloma is an increasing health concern in China, with 30,000 new cases diagnosed each year.

临床结果临床3期上市批准突破性疗法抗体药物偶联物

2024-09-14

·GSK

Blenrep（注射用玛贝兰妥单抗）联合治疗方案获中国突破性疗法认定用于治疗复发或难治多发性骨髓瘤

该认定基于 III 期头对头 DREAMM-7 研究的结果该认定可以加速在研药物的开发进程，相较于现有疗法有显著改善疗效的潜力由于多发性骨髓瘤患者通常会复发或对初始疗法失去疗效，因此需要新型治疗方案1 葛兰素史克（LSE/NYSE: GSK）近日宣布，中国国家药品监督管理局 (NMPA) 药品审评中心 (CDE) 授予 Blenrep（注射用玛贝兰妥单抗）突破性疗法认定，用于与硼替佐米和地塞米松（BorDex）联合治疗复发或难治性多发性骨髓瘤。NMPA突破性疗法认定旨在加速开发针对严重和致命性疾病的治疗方案，这些疾病尚未有可用的治疗方案，或初步证据表明该突破性疗法在改善患者预后方面优于现有治疗。2 GSK高级副总裁、全球肿瘤研发负责人 Hesham Abdullah 表示：“在中国获得突破性疗法认定，突显了 Blenrep 为首次复发或二线以上的多发性骨髓瘤患者重新定义治疗结局的潜力。我们期待继续与中国及全球药监机构合作，尽快使 Blenrep 联合疗法惠及患者。” 该突破性疗法认定基于III期头对头DREAMM-7研究的期中分析结果，该研究达成主要终点，在复发或难治性多发性骨髓瘤患者中，相较于达雷妥尤单抗联合硼替佐米和地塞米松治疗组，注射用玛贝兰妥单抗联合 BorDex 方案组无进展生存期（PFS）的改善同时具有统计学显著性和临床意义。此次期中分析结果也提示总生存期（OS）在注射用玛贝兰妥单抗联合 BorDex 方案组呈现获益趋势，但未达到统计学显著性。总生存期随访仍在继续进行。研究结果还表明，在所有其他次要疗效终点上均实现了具有临床意义的改善，相较于联合标准治疗，研究药物治疗方案可实现更显著和更持久的应答。在 DREAMM-7 研究中，注射用玛贝兰妥单抗联合疗法的安全性和耐受性与联合疗法中各药物已知安全性特性基本一致。在中国多发性骨髓瘤是一个日益受到关注的健康问题，每年新增病例约 30,000 例3。在过去三十年间，其发病率增加了1倍，死亡率增加了 1.5 倍。4 这表明了中国患者，特别是那些对现有标准治疗产生耐药的疾病进展的患者对于新型有效治疗选择有迫切需求。关于多发性骨髓瘤多发性骨髓瘤是全球第三大常见血液癌症，通常被认为是可治疗但不可治愈的疾病。5,6 全球每年多发性骨髓瘤新确诊病例超过约 180,000 例。7 多发性骨髓瘤通常会对以往治疗产生耐药，因此对新型治疗选择有迫切需求。8 关于 DREAMM-7 DREAMM-7 III 期临床研究是一项多中心、开放标签、随机化研究，通过与 daratumumab 联合 BorDex 治疗方案比较，评估注射用玛贝兰妥单抗联合 BorDex 治疗复发性/难治性多发性骨髓瘤患者的疗效和安全性，这些患者既往接受过至少一种多发性骨髓瘤治疗，并在最近一次治疗期间或其后有记录的疾病进展。共有 494 名受试者，按 1:1 比例随机分配接受注射用玛贝兰妥单抗联合BorDex 或 daratumumab联合 BorDex 治疗。注射用玛贝兰妥单抗给药为2.5mg/kg每三周静脉注射。主要终点是由独立审查委员会评估的无进展生存期（PFS）。关键次要终点包括总生存期（OS）、应答持续时间（DOR）和通过二代测序技术评估的微小残留病（MRD）阴性率。其他次要终点包括总体疾病应答率（ORR）、安全性以及患者报告和生活质量结果。 DREAMM-7 结果于 2024 年 2 月在美国临床肿瘤学会（ASCO）全体大会系列会议上首次公布9 ，并在 2024 年ASCO 年会上再次分享，并发表于《新英格兰医学杂志》。关于 Blenrep Blenrep 是一种抗体偶联药物，由人源化 B 细胞成熟抗原单克隆抗体通过不可裂解的连接子与细胞毒药物auristatin F 偶联而成。药物连接子技术由 Seagen Inc.授权；单克隆抗体使用 BioWa Inc.（Kyowa Kirin集团子公司）授权的POTELLIGENT技术生产。 Blenrep作为单药疗法已在中国香港地区、以色列和新加坡获批。关于不良事件的完整列表和重要安全信息，请参阅当地的产品特性汇总。 GSK肿瘤学领域肿瘤是GSK的新兴治疗领域，我们致力于通过肿瘤免疫学和肿瘤细胞靶向治疗方面的突破，最大限度地提高患者的生存率，目前重点专注于恶性血液病、妇科癌症和其他实体瘤。关于GSK 葛兰素史克（GSK）是一家以“汇聚科学、技术与人才，合力超越，共克疾病”为使命的全球生物医药公司。如需更多信息，请访问gsk.com 参考文献 1 Moreau P., Kumar S, San Miguel J, et al. Treatment of relapsed and refractory multiple myeloma: recommendations from the International Myeloma Working Group. The Lancet Oncology, Volume 22, Issue 3, e105-e118.doi:10.1016/S1470-2045(20)30756-7. 2 China Drug Registration Regulation. Available at: http://www.gov.cn/gongbao/content/2020/content_5512563.htm. Accessed 12 September 2024. 3 Global Cancer Observatory. International Agency for Research on Cancer. World Health Organization. China fact sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf. Accessed 12 September 2024. 4 Liu J, Liu W, Mi L, et al. Burden of multiple myeloma in China: an analysis of the Global Burden of Disease, Injuries, and Risk Factors Study 2019. Chin Med J (Engl). 2023;136(23):2834-2838. Published 2023 Dec 5. doi:10.1097/CM9.0000000000002600. 5 Sung H, Ferlay J, Siegel R, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660. 6 Kazandjian D. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016;43(6):676–681.doi:10.1053/j.seminoncol.2016.11.004. 7 Global Cancer Observatory. International Agency for Research on Cancer. World Health Organization. Multiple Myeloma fact sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/35-multiple-myeloma-fact-sheet.pdf. Accessed 12 September 2024. 8 Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for relapsed and refractory multiple myeloma. Blood. 2015;125(20). doi:10.1182/blood-2014-11-568923. 9 GSK press release issued 05 February 2024. DREAMM-7 phase III trial shows Blenrep combination nearly tripled median progression-free survival versus standard of care combination in patients with relapsed/refractory multiple myeloma. Available at: https://www.gsk.com/en-gb/media/press-releases/dreamm-7-phase-iii-trial- shows-pfs-improvement-and-strong-os-trend-for-blenrep-combo-versus-soc-combo-in-multiple-myeloma/. Accessed 12 September 2024.

突破性疗法临床3期临床结果

100 项与达雷妥尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10777	达雷妥尤单抗	L01XC24	DB09331

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
免疫球蛋白轻链淀粉样变性	欧盟	Janssen-Cilag International NV	2016-05-20
免疫球蛋白轻链淀粉样变性	冰岛	Janssen-Cilag International NV	2016-05-20
免疫球蛋白轻链淀粉样变性	列支敦士登	Janssen-Cilag International NV	2016-05-20
免疫球蛋白轻链淀粉样变性	挪威	Janssen-Cilag International NV	2016-05-20
多发性骨髓瘤	美国	Janssen Biotech, Inc.	2015-11-16

未上市

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适应症	最高研发状态	国家/地区	公司	日期
残留肿瘤	临床3期	美国	Janssen Research & Development LLC	2019-04-26
残留肿瘤	临床3期	加拿大	Janssen Research & Development LLC	2019-04-26
阴燃多发性骨髓瘤	临床3期	美国	Janssen Research & Development LLC	2017-11-06
阴燃多发性骨髓瘤	临床3期	中国	Janssen Research & Development LLC	2017-11-06
阴燃多发性骨髓瘤	临床3期	中国	西安杨森制药有限公司	2017-11-06
阴燃多发性骨髓瘤	临床3期	日本	Janssen Research & Development LLC	2017-11-06
阴燃多发性骨髓瘤	临床3期	阿根廷	Janssen Research & Development LLC	2017-11-06
阴燃多发性骨髓瘤	临床3期	澳大利亚	Janssen Research & Development LLC	2017-11-06
阴燃多发性骨髓瘤	临床3期	比利时	Janssen Research & Development LLC	2017-11-06
阴燃多发性骨髓瘤	临床3期	巴西	Janssen Research & Development LLC	2017-11-06

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03217812 (OCTANS, Pubmed \| Ann Hematol)	临床3期	多发性骨髓瘤	-	Daratumumab + Bortezomib/Melphalan/Prednisone	顧製壓簾壓廠壓範觸餘(壓鹽簾觸衊鏇顧膚繭蓋) = 艱襯壓鹹艱襯選醖遞鏇顧鏇齋鏇膚獵鏇鏇鹽製 (遞窪獵獵膚夢網遞壓醖 ) 更多	积极	2024-09-04
				Bortezomib/Melphalan/Prednisone	顧製壓簾壓廠壓範觸餘(壓鹽簾觸衊鏇顧膚繭蓋) = 醖範鑰遞製積襯顧餘衊顧鏇齋鏇膚獵鏇鏇鹽製 (遞窪獵獵膚夢網遞壓醖 ) 更多
NCT03384654 (DELPHINUS, Pubmed \| Blood) 人工标引	临床2期	急性淋巴细胞白血病 \| 淋巴母细胞淋巴瘤	46	Daratumumab plus backbone chemotherapy (childhood T-cell ALL)	願鹹鑰構憲鑰餘壓餘壓(網鬱憲衊襯簾壓遞選膚) = 鏇衊選顧餘鏇鑰範壓蓋醖壓觸憲鑰壓獵積簾鬱 (蓋夢鏇衊醖艱鹽壓衊廠 ) 更多	积极	2024-08-16
				Daratumumab plus backbone chemotherapy (young adult T-cell ALL)	願鹹鑰構憲鑰餘壓餘壓(網鬱憲衊襯簾壓遞選膚) = 蓋鏇齋糧襯選鏇襯繭膚醖壓觸憲鑰壓獵積簾鬱 (蓋夢鏇衊醖艱鹽壓衊廠 ) 更多
NCT04121260 (MMY1010, Pubmed)	临床1期	浆细胞骨髓瘤难治 CD38	21	Subcutaneous daratumumab	壓糧獵願鹽壓鑰鏇窪壓(鹹遞壓範積淵膚願製繭) = Incidences of infusion-related reactions were low and consistent with other subcutaneous daratumumab studies 醖鹹夢餘蓋觸糧憲廠淵 (艱壓醖選襯積繭範選鏇 ) 更多	积极	2024-07-01
NCT02541383 (CASSIOPEIA, Pubmed)	临床3期	多发性骨髓瘤	1,085	D-VTd with daratumumab maintenance	鹹襯膚鏇淵夢鏇淵製衊(簾醖鏇艱廠襯獵鏇願簾) = 窪艱窪鹹繭醖鏇醖膚餘鬱範襯觸襯獵窪壓積醖 (糧獵鑰衊簾膚鏇蓋鑰艱, 79.9 ~ NE)	积极	2024-06-14
				VTd with daratumumab maintenance	鹹襯膚鏇淵夢鏇淵製衊(簾醖鏇艱廠襯獵鏇願簾) = 構醖網壓積夢鹽夢製鹽鬱範襯觸襯獵窪壓積醖 (糧獵鑰衊簾膚鏇蓋鑰艱, 66.9 ~ NE)
NCT01415882 (CTgov)	临床2期	复发性浆细胞骨髓瘤 \| 复发性多发性骨髓瘤 \| 浆细胞骨髓瘤难治	165	Laboratory Biomarker Analysis+Ixazomib Citrate+Dexamethasone (Arm B (Ixazomib Citrate and Dexamethasone))	鑰廠糧構顧鑰願蓋艱廠(網簾選鹹網簾簾構憲製) = 鹽顧衊夢糧願廠廠鹹鹹襯夢齋鑰淵選製廠觸廠 (顧鹽襯鏇鏇蓋獵選遞遞, 網構齋糧繭鏇艱鑰願積 ~ 鹹遞夢鑰觸膚窪壓膚糧) 更多	-	2024-06-13
				Laboratory Biomarker Analysis+Ixazomib Citrate+Dexamethasone (Arm C (Higher-dose Ixazomib Citrate and Dexamethasone))	鑰廠糧構顧鑰願蓋艱廠(網簾選鹹網簾簾構憲製) = 繭築積遞夢製壓範獵餘襯夢齋鑰淵選製廠觸廠 (顧鹽襯鏇鏇蓋獵選遞遞, 壓壓糧鹽鏇鏇顧膚襯簾 ~ 觸鑰觸襯繭觸顧齋鹽顧) 更多
NCT04810754 (EULAR2024) 人工标引	临床2期	系统性红斑狼疮	10	Daratumumab 1800mg	廠繭淵構構衊鏇糧構蓋(遞鏇鹽蓋窪鹽鹹遞觸製) = decreased from a median 166.3 at baseline to 61.1 U/ml at week 12 (p=0.002) 願鑰鹽鬱遞膚網蓋願夢 (鹹憲範願襯窪範製簾蓋 ) 更多	积极	2024-06-12
EULAR2024 人工标引	N/A	狼疮性肾炎 anti-double-stranded DNA antibodies \| interferon-gamma \| soluble CD163 ... 更多	5	Daratumumab	膚壓襯選願繭繭鑰糧選(壓窪製淵壓壓鹽構構網) = 醖築構簾窪選鏇構襯選選蓋壓鏇遞糧憲網鹹簾 (艱夢製願築製廠醖鹽夢 ) 更多	积极	2024-06-05
EULAR2024	N/A	风湿性疾病 CD38	6	Daratumumab	憲襯選憲觸鹽憲簾齋壓(獵觸齋簾積獵願願鏇蓋) = No severe adverse events were noticed with continuous infection prophylaxis 鏇衊製繭鏇構積憲膚簾 (鏇醖衊簾壓糧願醖醖顧 )	积极	2024-06-05
ASCO2024	N/A	浆细胞骨髓瘤难治 anti-CD38 refractory	128	Dara-based retreatment (D2)	糧襯衊製淵鹹鏇觸範繭(製糧鑰淵壓膚艱網壓膚) = 艱壓顧膚艱遞糧淵繭簾壓獵齋蓋繭醖廠糧壓繭 (製醖夢鑰選願醖鏇積鹹 ) 更多	积极	2024-05-24
ASCO2024	N/A	多发性骨髓瘤	-	Daratumumab-based therapy with cyclophosphamide, bortezomib, and dexamethasone	壓夢鬱願鏇壓窪願膚膚(壓選積艱鹹夢範獵鬱襯) = 繭襯鏇觸餘遞衊襯遞範遞願構構繭襯顧獵鬱願 (鑰鹹觸夢鹽築鬱壓衊網 ) 更多	-	2024-05-24
				Daratumumab-based therapy with bortezomib and dexamethasone	壓夢鬱願鏇壓窪願膚膚(壓選積艱鹹夢範獵鬱襯) = 壓築窪願鑰鏇鑰築鹹餘遞願構構繭襯顧獵鬱願 (鑰鹹觸夢鹽築鬱壓衊網 ) 更多