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

+ [6]

靶点

CD38

作用方式

抑制剂

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

肿瘤免疫系统疾病内分泌与代谢疾病+ [7]

在研适应症

阴燃多发性骨髓瘤免疫球蛋白轻链淀粉样变性多发性骨髓瘤+ [19]

非在研适应症

淋巴母细胞淋巴瘤难治性B细胞淋巴瘤结外NK-T细胞淋巴瘤+ [12]

原研机构

Janssen Global Services LLC

在研机构

Genentech, Inc.Janssen Research & Development LLC

西安杨森制药有限公司

+ [17]

非在研机构-

权益机构

Genmab A/S

Janssen Biotech, 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)、孤儿药 (韩国)、孤儿药 (英国)、优先审评 (日本)、附条件批准 (中国)、孤儿药 (日本)

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结构/序列

Sequence Code 9075449L

来源: *****

Sequence Code 9946743H

来源: *****

关联

352

项与达雷妥尤单抗相关的临床试验

NCT07082270

/ Not yet recruiting临床1期IIT

Phase I Trial of GB1211 (Selvigaltin), an Oral Galectin-3 (Gal-3) Inhibitor, Combined With Standard of Care Treatment in Relapsed/Refractory Multiple Myeloma (RRMM)

This phase I trial studies the side effects and best dose of selvigaltin when given together with standard of care treatment (daratumumab-hyaluronidase, carfilzomib, dexamethasone) in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Selvigaltin works by blocking the activity of a protein called galectin-3. Galectin-3 is involved in various cellular processes, including inflammation and tissue scarring, which is associated with worse outcomes in several forms of cancer. By blocking the activity of galectin-3, selvigaltin may help reduce inflammation and tissue scarring. Daratumumab-hyaluronidase is a drug composed of daratumumab and hyaluronidase. 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, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Hyaluronidase helps deliver the daratumumab to CD38-expressing cancer cells. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving selvigaltin with standard of care treatment may be safe, tolerable, and/or effective in treating patients with relapsed or refractory multiple myeloma.

开始日期2026-02-01

申办/合作机构

Roswell Park Comprehensive Cancer Center

NCT07191379

/ Not yet recruiting临床4期IIT

Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma. An Open Label, Phase Four, Prospective, Non-randomized, Sponsor-initiated Multicenter Feasibility Study

The main goal in this open label, phase four, prospective, non-randomized, sponsor-initiated multicenter feasibility study is to evaluate the feasibility and safety of self-administration of subcutaneously (SC) daratumumab in the patients with multiple myeloma in their own home. The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting. To reduce potential bias, patients will function as their own controls by receiving alternating treatments at home and in the outpatient clinic. To participate, patients must be scheduled for SC daratumumab alone or in combination with other drugs not necessitating outpatient visits on days of planned SC daratumumab self-administration. Patients can be included and trained during cycle 1 and 2, but only treatments administered in cycle 3-6 are considered protocol treatments. Here, patients will receive SC daratumumab once every second week with treatments at day 1 administered in the outpatient clinic and treatments at day 15 administered at home. From cycle 7 onwards, patients continues SC daratumumab outside protocol according to local standards.
At inclusion, baseline demographic and clinical data should be registered for included patients. For each SC daratumumab administration in the protocol, planned treatment location (home/hospital) should be registered together with information on whether the dose was administered as planned. For each protocol treatment, regardless of treatment location, patients, caregivers, and healthcare professionals should register their time spent. In addition, patients should complete the Health Literacy Questionnaire (HLQ) and caregivers are to complete the Caregiver Roles and Responsibilities Scale (CRRS). Throughout the study, patient will also register all unplanned contacts to the healthcare system. Patient will also be asked to complete an evaluation form. Lastly, qualitative evaluations of the experience of self-administration will be conducted through semi-structured interviews with patients and caregivers, as well as focus group interviews with involved healthcare professionals.

开始日期2026-01-01

申办/合作机构

Odense University Hospital

NCT06348147

/ Suspended临床2期

An Attenuated Schedule Dara-RVd Induction for Patients With Newly Diagnosed Multiple Myeloma Who Are Eligible for Autologous Stem Cell Transplantation

This Phase II hybrid decentralized trial will examine the effect of daratumumab-based quadruplet induction therapy administered at an attenuated schedule in subjects with newly diagnosed multiple myeloma (NDMM) who are eligible for standard-of-care autologous stem cell transplantation (ASCT). Daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd) have recently become a standard induction regimen for patients with NDMM who are eligible for ASCT in the United States. As implemented in clinical trials, Dara-RVd involves twice weekly bortezomib administration, which is inconvenient for patients and may result in increased rates of limiting toxicity, such as peripheral neuropathy. Adoption of alternate schedules involving once-weekly bortezomib is common in real-world practice, however a paucity of prospective data supporting this practice exists.
This study examines the efficacy of an attenuated Dara-RVd schedule involving once-weekly bortezomib dosing.

开始日期2026-01-01

申办/合作机构

Lineberger Comprehensive Cancer Center

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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2,137

项与达雷妥尤单抗相关的文献（医药）

2026-01-01·BIOMATERIALS

CD38-targeted antibody-polymer drug conjugates for enhanced treatment of multiple myeloma

Article

作者: Li, Shannuo ; Al Faruque, Hasan ; Yang, Jiyuan ; Li, Jiahui ; Kopeček, Jindřich ; Sborov, Douglas W

Multiple myeloma (MM) remains a formidable disease, especially in relapsed or refractory cases when there are limited treatment options. In this study, we introduce two polymer-antibody drug conjugates (pADCs), ISA-P-EPI (U6244-021) and DARA-P-EPI (U6244-031), which contain semitelechelic N-(2-hydroxypropyl)methacrylamide (HPMA) copolymer-epirubicin (EPI) conjugate attached to CD38-targeting antibodies Isatuximab (ISA) and Daratumumab (DARA). These pADCs enhance therapeutic efficacy by combining the specificity of ISA and DARA with the cytotoxic potency of EPI while preserving antibody function. The EPI is linked to the HPMA polymer backbone via a tetrapeptide spacer cleavable by lysosomal enzymes, enabling drug release upon endocytosis within tumor cells. This design achieves a higher drug-to-antibody ratio than conventional ADCs for safer delivery of drug payload. In vitro studies demonstrate efficient binding, internalization, and cytotoxic efficacy of these pADCs in MM cell lines. Mechanistic investigations revealed significant therapeutic effects, including cell cycle arrest, immunogenic cell death, and preserved antibody-dependent cellular cytotoxicity (ADCC). In addition, pADCs were effective in 5 out of 8 primary samples, with their efficacy closely correlating with CD38 surface expression levels. To enhance therapeutic outcomes, we employed panobinostat to upregulate CD38 expression, which further improved pADC efficacy. In a preclinical NRG mouse model inoculated with MM.1S-luc cells, pADC treatment significantly delayed tumor progression and prolonged survival, with all treated mice remaining alive at the 100-day endpoint. These findings underscore the potential of CD38-targeted pADCs as a novel approach to combining chemotherapy with immunotherapy for MM treatment, warranting further investigation into their optimization and clinical application.

2025-12-31·ANNALS OF MEDICINE

Serum free light chain level-based and non-fixed cycle daratumumab treatment strategy for patients with light chain amyloidosis

Article

作者: Huang, Xianghua ; Guo, Jinzhou ; Chen, Wencui ; Li, Zhen ; Zhao, Liang ; Ren, Guisheng

BACKGROUND:

In recent years, daratumumab (DARA) has gained widespread use in the treatment of systemic light chain (AL) amyloidosis. In this study, we assessed the efficacy and safety of a DARA treatment strategy based on serum free light chain (sFLC) levels and non-fixed cycles.

METHODS:

The study included 123 patients with Al amyloidosis who received DARA at our center between July 2020 and September 2023. All patients received the standard DARA treatment (16 mg/kg weekly for four weeks) during the first course. Subsequent treatments were adjusted based on sFLC levels and the physician's judgment.

RESULTS:

The results demonstrated an impressive overall hematologic response rate (ORR) of 94.3%, with a hematologic very good partial response (VGPR) and complete response (CR) rate of 84.5%. Median time to best hematologic response was 1 months. Cardiac and renal response rates were 39.3% and 60.3%, respectively. Thirty patients experienced grade 1/2 infusion-related reactions after the first infusion. The rate of grade 3/4 adverse events was 21%. The most common adverse events of grade 3 or 4 were pulmonary infection (6.5%), neutropenia and lymphocytopenia (5.7%), elevated transaminases (1.6%), acute kidney injury (1.6%). After a median follow-up of 13 months (range 1-38), The 1-year OS and PFS estimates were 96.5% and 84.4%, respectively.

CONCLUSION:

These findings indicate that the sFLC levels based and non-fixed cycle DARA strategy is an efficacious and safe treatment strategy in both newly diagnosed and relapsed/refractory AL amyloidosis.

2025-12-31·ANNALS OF MEDICINE

Clinical outcome of ≥2% circulating tumor cells in newly diagnosed multiple myeloma: insights from a multicenter study

Article

作者: Liang, Dong ; Wang, Hua ; Xia, Zhongjun ; Feng, Yuan ; Yan, Yurong ; Jin, Fengyan ; Chen, Xiaoqin ; Nie, Xiaomiao ; Zeng, Min ; Bu, Yuying ; Bai, Shenrui ; Liang, Yang ; Wang, Qiaoli ; Xu, Weiling ; Feng, Demei

PURPOSE:

Previous studies have shown that ≥2% circulating tumor cells (CTCs) in multiple myeloma are associated with a prognosis similar to primary plasma cell leukemia. This study aims to examine this ultra-high-risk patient subset and evaluate their clinical outcomes in a real-world clinical setting.

METHODS:

We included 1,056 newly diagnosed multiple myeloma patients treated with novel agents. CTCs levels were determined via morphological assessment on peripheral blood smears, using a 2% cutoff to stratify patients into <2% and ≥2% CTCs groups. We then evaluated clinical outcomes across these groups.

RESULTS:

Patients with ≥2% CTCs constitute an ultra-high-risk subgroup, with outcomes resembling those of primary plasma cell leukemia. Survival outcomes improved for patients receiving daratumumab-based quadruplet therapy. Single autologous stem cell transplantation (ASCT) partially improved outcomes for patients with ≥2% CTCs. Achieving complete remission (CR) after induction treatment did not confer a better prognosis for this population. Furthermore, one high-risk cytogenetic abnormality (HRA) worsened outcomes in the <2% CTC group, while ≥2 HRA were associated with poorer outcomes in the ≥2% CTC group. Concurrent 1q21+ and other HRA further conferred a worse prognosis. In de novo extramedullary extraosseous (EME) multiple myeloma, defined as patients presenting with soft tissue or visceral plasmacytomas not connected to bone at initial diagnosis, ≥2% CTCs remained a strong predictor of poor prognosis.

CONCLUSION:

Our study suggests that patients with ≥2% CTCs represent a distinct ultra-high-risk subgroup in multiple myeloma and warrant separate consideration. VRD, IRD, DVRD, and DRD were reliable choices as frontline therapies for patients with <2% CTCs. Daratumumab-based quadruplet therapy may be a promising option for patients with ≥2% CTCs. Further research should continue to explore this specific aspect in greater depth.

1,100

项与达雷妥尤单抗相关的新闻（医药）

2025-09-23

·药明康德

更多患者癌细胞几乎完全消失！百时美施贵宝小分子3期积极结果公布百时美施贵宝（Bristol Myers Squibb）今日宣布，其3期EXCALIBER-RRMM研究在预设的期中分析显示，在研E3泛素连接酶cereblon调节剂（CELMoD）iberdomide联合标准治疗（daratumumab+地塞米松）用于复发或难治性多发性骨髓瘤（RRMM）时，与活性对照药物相比可显著提高最小残留病（MRD）阴性率。依据试验方案并经数据安全监察委员会（DMC）建议，研究将不做修改继续推进，以评估另一项共同主要终点无进展生存期（PFS），以及关键次要终点包括总生存期（OS）与安全性等。本研究中iberdomide联合标准治疗的安全性总体与既往研究一致。 EXCALIBER-RRMM为一项多中心、两阶段、随机、开放标签3期研究，旨在评估iberdomide联合标准治疗，与daratumumab、bortezomib、地塞米松（DVd）相较，在RRMM人群中的疗效与安全性。试验共同主要终点为MRD阴性率与PFS，并包含OS、总缓解率（ORR）、缓解持续时间（DoR）、发生疾病进展时间（TTP）、下一线治疗时间（TTNT）及与健康相关的生活质量（HR-QoL）等次要终点。第一阶段基于安全性、药代动力学与疗效数据确定1.0 mg iberdomide为最优剂量；第二阶段约随机入组664例患者。 3.49亿美元！默沙东达成小分子药物开发合作 Variational AI今日宣布与默沙东（MSD）达成合作，将运用其Enki平台为默沙东指定的两个未披露靶点设计并优化新型小分子候选药物。根据协议，Variational AI将基于默沙东的专有数据对Enki进行定制化训练，用于生成与优化针对指定靶点的小分子化合物；默沙东将享有由本次合作产生化合物的独家开发与商业化权利。交易条款包括一笔预付款，此外Variational AI还有资格获得里程碑付款，潜在交易总额最高可达3.49亿美元。 Enki平台基于基础模型，训练数据来源包括Variational AI的内部数据、经遴选整合的公开数据库，以及其自有的生成式模型。该平台可依据合作方的目标产品特性（TPP）创建并优化小分子先导化合物。本次合作将Enki的生成与优化能力与默沙东的专有数据相结合，旨在加速新分子从设计到成药性的迭代与筛选效率，为后续临床开发与商业化奠定基础。参考资料： [1] Variational AI Enters Collaboration with Merck to Apply Generative AI to Drug Discovery. Retrieved September 23, 2025 from https://variational.ai/featured/variational-ai-enters-collaboration-with-merck-to-apply-generative-ai-to-drug-discovery/ [2] Bristol Myers Squibb Announces Phase 3 EXCALIBER-RRMM Study Evaluating Iberdomide in Combination with Standard Therapies Demonstrated a Significant Improvement in Minimal Residual Disease Negativity Rates in Relapsed or Refractory Multiple Myeloma. Retrieved September 23, 2025 from https://www.businesswire.com/news/home/20250923828240/en/Bristol-Myers-Squibb-Announces-Phase-3-EXCALIBER-RRMM-Study-Evaluating-Iberdomide-in-Combination-with-Standard-Therapies-Demonstrated-a-Significant-Improvement-in-Minimal-Residual-Disease-Negativity-Rates-in-Relapsed-or-Refractory-Multiple-Myeloma 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床3期临床结果临床成功引进/卖出

2025-09-23

·新药猎人笔记

下一代重磅MM药物iberdomide能否成为第一个根据替代终点MRD获批的药物？

2025年9月24日，百时美施贵宝（BMS）宣布，其新一代多发性骨髓瘤在研药物iberdomide在一项关键III期临床试验中取得积极结果，显著提高了患者达到微小残留病（MRD）阴性的比例，意味着药物在清除可检测癌症方面表现优于标准治疗方案。该消息引发业内广泛关注，市场普遍关注其是否能借此获得美国食品药品监督管理局（FDA）的加速批准。 iberdomide：新一代蛋白降解药物表现亮眼据BMS于9月23日发布的数据，iberdomide联合达雷妥尤单抗（Darzalex）和地塞米松的治疗方案，在复发/难治性多发性骨髓瘤患者中显著提高了MRD阴性率，达到研究设定的主要终点之一。这一结果表明，该组合疗法在清除癌细胞方面优于传统的达雷妥尤单抗+硼替佐米+地塞米松方案。 Iberdomide属于新一代Cereblon E3连接酶调节剂（CELMoD），通过靶向降解关键转录因子（如Aiolos和Ikaros）发挥抗癌作用。与第一代免疫调节药物（如Revlimid和Pomalyst）相比，iberdomide具有更强的靶向亲和力和更广泛的抗肿瘤活性，尤其在耐药患者中显示出潜力。是否足以获得FDA批准？关键终点仍在评估中尽管iberdomide在MRD指标上取得突破，但FDA是否批准仍取决于其是否能同时证明对无进展生存期（PFS）和总生存期（OS）的显著改善，而这些数据仍在收集中。BMS表示，研究将继续进行，以评估这些关键终点，并计划与监管机构讨论下一步行动。值得注意的是，FDA曾在2024年召开顾问委员会会议，专家一致支持将MRD作为加速批准的替代终点，这为iberdomide的审批路径提供了政策依据。然而，BMS首席执行官Chris Boerner也指出，FDA内部人事变动可能影响审批取向，公司需谨慎评估监管策略。 Iberdomide能否成为“下一个Revlimid” Iberdomide被视为BMS血液肿瘤管线的“接班人”之一。随着Revlimid等明星产品面临专利悬崖和销售下滑，BMS正加速推进包括iberdomide在内的三款蛋白降解药物，以期在多发性骨髓瘤领域延续其市场领导地位。此外，BMS与2seventy bio合作的CAR-T疗法Abecma已于2024年获得FDA批准，用于更早线治疗多发性骨髓瘤，进一步巩固其在该领域的布局。分析师普遍认为，若iberdomide最终获得FDA批准，其市场潜力巨大。据估计，该药物在复发/难治性多发性骨髓瘤领域具有80-90%的获批概率，并有望拓展至新诊断患者及维持治疗阶段，成为BMS未来增长的重要引擎。 BMS表示，将在2025年底至2026年初提交iberdomide的上市申请，具体时间表将取决于后续临床数据的成熟度和与FDA的沟通结果。关于微小残留病（MRD）：微小残留病（MRD）指的是患者在接受治疗后体内可能残留的少量癌细胞，这些癌细胞使用常规诊断方法无法检测到。在多发性骨髓瘤中，MRD 评估已成为一种高度敏感且具有临床意义的工具，用于评估治疗反应。MRD 阴性并不一定意味着所有癌细胞都已消失，但它可能预示着更好的临床结果，包括更长的缓解期和生存期。现代微小残留病灶（MRD）检测方法，如下一代测序（NGS）和下一代流式细胞术（NGF），能够在 10 万至 100 万个正常细胞中识别出一个恶性细胞（MRD 的阈值），在测量疾病负担方面提供了前所未有的精准度。MRD 在临床试验中作为无进展生存期（PFS）的替代终点被越来越多地使用，并因其在加速治疗开发方面的作用而获得监管机构的认可。结束语： Iberdomide的阶段性胜利为BMS注入一针强心剂，但是否能顺利获批，仍需等待更全面的疗效数据。对于全球数以万计的多发性骨髓瘤患者而言，这款新药或许代表着新的希望，而BMS也正站在重塑血液瘤治疗格局的关键节点。参考文献： 1. BioPharma Dive, Bristol Myers says next-gen blood cancer drug hits goal in key study, 2025-09-23 2. Fierce Biotech, BMS reports phase 3 win in multiple myeloma, 2025-09-23 3. NIH, Industry update: the latest developments in the field of therapeutic delivery, 2024-04-03 4. OmicsX, The CELMoD Revolution: How Bristol-Myers’ Iberdomide and Mezigdomide Could Redefine Multiple Myeloma Treatment, 2025-08-08 5. OncLive, A New Era In Multiple Myeloma Treatment: Advances and Future Directions, 2025-08-26 6. BMS news room, Bristol Myers Squibb Announces Phase 3 EXCALIBER-RRMM Study Evaluating Iberdomide in Combination with Standard Therapies Demonstrated a Significant Improvement in Minimal Residual Disease Negativity Rates in Relapsed or Refractory Multiple Myeloma，2025-09-23

临床3期加速审批细胞疗法免疫疗法

2025-09-23

·FierceBiotech

Bristol Myers midtrial endpoint addition secures phase 3 win in multiple myeloma

Investigators are continuing to track patients in a phase 3 multiple myeloma trial to evaluate progression-free and overall survival.\n Bristol Myers Squibb has ended its R&D losing streak with a hit on one of the dual primary endpoints in a phase 3 multiple myeloma trial. But with the study continuing to evaluate the other primary endpoint, it is unclear whether the drugmaker has the evidence needed to seek approval from the FDA.The phase 3 trial evaluated the effect of combining BMS’ investigational cereblon E3 ligase modulator iberdomide with the approved CD38 drug Darzalex and steroid dexamethasone. Relapsed or refractory multiple myeloma patients either received the investigational regimen or the standard combination of Darzalex, bortezomib and dexamethasone.BMS reported statistically significant improvement in minimal residual disease (MRD) negativity rates in the iberdomide arm, meeting one of the dual primary endpoints of the trial. Investigators are continuing to track patients to evaluate progression-free and overall survival, which are respectively a dual primary and key secondary endpoint. BMS plans to discuss the results with health authorities. The company added MRD as a dual primary endpoint partway through the study. Samit Hirawat, M.D., who recently stepped down as chief medical officer at BMS, said in February that the company added the MRD endpoint after talking to the FDA, telling investors that the change was part of an attempt to “figure out how to accelerate the process of drug development.” BMS added the endpoint after every member of an FDA advisory committee answered “yes” in 2024 to the question “does the evidence support the use of MRD as an accelerated approval endpoint in multiple myeloma trials?” The vote took place before the recent changes to the leadership at the FDA.Morgan Stanley analyst Terence Flynn asked BMS CEO Chris Boerner, Ph.D., where the FDA stands on MRD and the possibility of accelerated approval earlier this month. Talking at the Morgan Stanley event, Boerner said the study was reviewed by the agency but noted that there are “some new players at [the] FDA now.”Nonetheless, the phase 3 victory is a positive for a R&D group that has suffered a series of setbacks. This year, BMS has reported the failures of phase 3 trials in melanoma, cardiomyopathy and schizophrenia. In a recent look at BMS’ upcoming readouts, BMO Capital Markets analysts classed the phase 3 iberdomide data as being of medium importance to the company.

临床3期加速审批高管变更临床结果

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

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
阴燃多发性骨髓瘤	欧盟	Janssen-Cilag International NV	2025-07-24
阴燃多发性骨髓瘤	冰岛	Janssen-Cilag International NV	2025-07-24
阴燃多发性骨髓瘤	列支敦士登	Janssen-Cilag International NV	2025-07-24
阴燃多发性骨髓瘤	挪威	Janssen-Cilag International NV	2025-07-24
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

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
复发性多发性骨髓瘤	临床3期	美国	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	日本	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	澳大利亚	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	比利时	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	丹麦	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	法国	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	德国	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	希腊	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	以色列	Janssen Research & Development LLC	2020-06-12
复发性多发性骨髓瘤	临床3期	意大利	Janssen Research & Development LLC	2020-06-12

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临床结果

适应症

分期

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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


NCT03792620 (Pubmed)	临床2期	多发性骨髓瘤 CD38	24	Daratumumab, Cyclophosphamide, Thalidomide, Dexamethasone	觸鹹壓夢壓淵鹽鹽憲鑰(艱壓醖繭鹽遞蓋窪醖範) = 鹽廠糧範簾窪衊遞壓簾繭鏇齋繭艱憲願構鏇糧 (鑰窪繭鹹艱糧範憲夢廠, 68.3 ~ 98.7)	积极	2025-08-01
NCT04230304 (CTgov)	临床2期	复发性慢性淋巴细胞白血病 \| 难治性慢性淋巴细胞白血病 \| 难治性小淋巴细胞淋巴瘤	8	Ibrutinib+Daratumumab	窪顧壓膚窪願餘顧廠窪 = 鑰製顧夢齋齋獵餘鬱膚艱醖壓積鹹獵糧鑰襯製 (夢糧鹽蓋襯憲網積壓鏇, 築顧鬱繭築製鬱廠膚鬱 ~ 鏇觸顧製衊壓築積鏇鏇) 更多	-	2025-07-01
NCT03012880 (CTgov)	临床2期	多发性骨髓瘤	80	lenalidomide+ixazomib citrate+daratumumab+dexamethasone (Cohort A)	鏇餘壓蓋鏇積糧醖衊廠 = 壓顧膚範遞鬱獵積蓋構膚製鏇壓齋選鹹憲網範 (糧廠範衊觸膚鏇範顧廠, 鬱獵鑰憲構製鏇醖餘鹽 ~ 淵鹽夢遞顧築齋獵鹹遞) 更多	-	2025-06-04
				lenalidomide+ixazomib citrate+daratumumab+dexamethasone (Cohort B)	鏇餘壓蓋鏇積糧醖衊廠 = 夢蓋網構夢夢繭廠範鹹膚製鏇壓齋選鹹憲網範 (糧廠範衊觸膚鏇範顧廠, 簾製製繭遞糧壓壓窪淵 ~ 積艱襯積憲淵廠觸遞簾) 更多
NCT04268498 (ADVANCE, ASCO2025)	临床2期	多发性骨髓瘤 minimal residual disease (MRD) positive	306	DKRd (Daratumumab, Carfilzomib, Lenalidomide, Dexamethasone)	範積醖夢簾積願鏇顧餘(衊憲簾蓋鏇夢遞顧鹽憲): adjusted OR = 2.5 (95% CI, 1.5 ~ 4.2) 更多	积极	2025-05-30
				KRd (Carfilzomib, Lenalidomide, Dexamethasone)
ASCO2025	N/A	多发性骨髓瘤	804	Daratumumab	膚簾憲觸築醖壓蓋鹹顧(積觸顧製廠鑰築憲網網) = 獵遞網遞壓願齋製廠壓選蓋衊繭醖襯鬱糧鏇繭 (齋醖積鏇廠蓋觸構觸鬱 ) 更多	积极	2025-05-30
				Lenalidomide	膚簾憲觸築醖壓蓋鹹顧(積觸顧製廠鑰築憲網網) = 憲鬱鏇顧獵顧廠顧簾製選蓋衊繭醖襯鬱糧鏇繭 (齋醖積鏇廠蓋觸構觸鬱 ) 更多
NCT04661137 (phase 2b study of selinexor, ASCO2025)	临床2期	多发性骨髓瘤	28	Selinexor 80 mg + Carfilzomib 20 mg/m2 + Dexamethasone	蓋糧遞淵衊衊選製繭齋(簾窪繭夢齋鏇憲獵糧廠) = 選蓋繭簾糧衊鬱糧襯齋醖範餘齋觸築憲繭醖願 (範淵鑰膚艱獵鏇窪鹽齋 ) 更多	积极	2025-05-30
				Selinexor 60 mg + Pomalidomide 4 mg + Dexamethasone	蓋糧遞淵衊衊選製繭齋(簾窪繭夢齋鏇憲獵糧廠) = 選構壓鹽艱顧鑰衊壓鑰醖範餘齋觸築憲繭醖願 (範淵鑰膚艱獵鏇窪鹽齋 )
CEPHEUS (EHA2025)	临床3期	多发性骨髓瘤 del(17p) \| t(4;14) \| t(14;16) ... 更多	395	DARATUMUMAB, BORTEZOMIB, LENALIDOMIDE AND DEXAMETHASONE (DVRd)	壓願齋鏇獵壓選淵築餘(蓋遞鏇簾獵醖鹹範簾鏇) = 鹹窪範鏇觸糧鏇選築憲鬱膚鬱壓夢簾獵蓋淵糧 (遞窪衊簾餘衊選範糧積 ) 更多	积极	2025-05-22
NCT04181827 (CARTITUDE-4, CTgov)	临床3期	复发性多发性骨髓瘤 \| 多发性骨髓瘤	419	daratumumab+pomalidomide+bortezomib+dexamethasone (DPd) (Arm A: Standard Therapy: PVd or DPd)	鑰艱壓獵鏇鹽窪觸鹹鑰(壓襯鹽艱選選衊築範壓) = 選齋積製膚網醖齋觸築壓壓窪積鏇網窪獵鬱獵 (鏇鹹壓觸網範襯簾鑰夢, 醖廠襯築積願鑰齋鬱膚 ~ 襯積積憲糧餘鬱鏇獵糧) 更多	-	2025-05-20
				Autoleucel [Cilta-cel]+JNJ-68284528 (Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]))	鑰艱壓獵鏇鹽窪觸鹹鑰(壓襯鹽艱選選衊築範壓) = 築膚鏇襯願壓繭憲繭積壓壓窪積鏇網窪獵鬱獵 (鏇鹹壓觸網範襯簾鑰夢, 鏇襯築蓋築繭壓願餘鑰 ~ 糧選製窪構鹽壓夢範窪) 更多
PB2995 (EHA2025)	临床2期	多发性骨髓瘤维持	22	Daratumumab	餘廠選淵鑰構鏇艱構艱(鹽選顧淵憲齋鬱構構淵) = 衊衊選簾憲鑰願獵醖窪艱築襯鬱餘選構憲範願 (壓蓋衊衊憲鹹鏇夢壓鹹 ) 更多	积极	2025-05-14
				Bortezomib	餘廠選淵鑰構鏇艱構艱(鹽選顧淵憲齋鬱構構淵) = 鹽齋襯蓋範廠遞鬱願獵艱築襯鬱餘選構憲範願 (壓蓋衊衊憲鹹鏇夢壓鹹 )
EHA2025	N/A	免疫球蛋白轻链淀粉样变性一线 NTproBNP \| high-sensitivity troponin T \| myocardial global longitudinal strain (GLS)	325	Daratumumab-based regimens	廠餘膚醖襯襯衊襯艱獵(餘蓋壓糧願憲範鑰窪鏇) = 鹽繭遞淵築鬱壓蓋醖製顧憲網選夢選網鏇憲選 (窪窪醖願膚鹽鬱醖襯構 ) 更多	-	2025-05-14
				Bortezomib-combination	廠餘膚醖襯襯衊襯艱獵(餘蓋壓糧願憲範鑰窪鏇) = 獵衊選夢膚獵淵遞壓選顧憲網選夢選網鏇憲選 (窪窪醖願膚鹽鬱醖襯構 )