Phase I study of pomalidomide-R-CHOP for patients with newly diagnosed diffuse large B-cell lymphoma who are at high risk of central nervous system relapse

开始日期2025-08-01

申办/合作机构

Asan Medical Center

NCT07018050

/ Not yet recruiting临床2期

A Multicenter, Open-Label Phase II Study to Evaluate QLS32015 Combination Therapy in the Treatment of Multiple Myeloma

The purpose of the study is to compare the efficacy of QLS32105 (SC) in combination with Pomalidomide, and QLS32105 (SC) in combination with QL2109 or Daratumumab, and QLS32105 (SC) in combination with QL2109 or Daratumumab and Pomalidomide, and QLS32105(SC) in combination with Bortezomib and Lenalidomide.

开始日期2025-07-01

申办/合作机构

齐鲁制药有限公司

NCT07015021

/ Not yet recruitingN/AIIT

The Efficacy and Safety of the Combination Therapy of Daratumumab, Cabozantinib, Pomalidomide, and Dexamethasone (D-KPd) in the Treatment of High-risk First-time Relapsed or Primary Refractory MM Patients: a Randomized, Open Label, Single Arm, Single Center Clinical Study

This study is a prospective, single center, single arm phase II clinical trial. The study population consists of patients who have received treatment with VRd or VRd lite regimens for 2-8 courses in the past and have achieved therapeutic effects, but have progressed during treatment (primary refractory), experienced clinical recurrence for the first time after treatment, or progressed or recurred after the first transplant (without entering maintenance therapy). 72 patients are planned to be enrolled and receive 4 courses of induction therapy with D-KPd regimen for the first efficacy evaluation. For patients with ≥ SD, if the patient has ≥ PR and is suitable for ASCT, ASCT treatment will be given. For patients with

开始日期2025-06-01

申办/合作机构

苏州大学附属第一医院

100 项与泊马度胺相关的临床结果

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100 项与泊马度胺相关的转化医学

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100 项与泊马度胺相关的专利（医药）

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2,792

项与泊马度胺相关的文献（医药）

2025-09-01·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Reversing an agonist into an inhibitor: Development of mTOR degraders

Article

作者: Li, Ruichen ; Zhu, Liquan ; Chen, Zhe ; Zhou, Yiyu ; Fu, Siyi ; Meng, Xuli ; Ma, Longfei ; Zeng, Qian ; Qian, Huijuan ; Ge, Jingyan

Targeted protein degradation using proteolysis-targeting chimeras (PROTACs) has emerged as a powerful strategy for modulating protein function. In this study, we developed mTOR-targeting PROTACs by conjugating the mTOR agonist MHY-1485 to the Cereblon (CRBN) ligand pomalidomide, demonstrating that even activators can serve as effective warheads for targeted protein degradation. Through systematic screening, we identified PD-M6 as a potent bifunctional molecule capable of degrading mTOR (DC₅₀ = 4.8 μM), reversing the proliferative effects of MHY-1485, and inhibiting cell proliferation (IC₅₀ = 11.3 μM) while inducing autophagy, akin to the mTOR known inhibitor rapamycin. Proteomic analysis further revealed that PD-M6 downregulated key proteins in the mTOR signaling pathway, including LAMTOR1, MAPKAP1, and CASTOR1, which are involved in proteasome-mediated degradation, cell division, apoptosis, and lysosomal signaling. Notably, PD-M6 specifically induced the degradation of LAMTOR1. These findings highlight a novel approach for designing PROTACs from agonists, broadening the scope of targeted protein degradation strategies for therapeutic applications.

2025-08-01·PHARMACOLOGICAL RESEARCH

Trend in the use of biological drugs in pediatric patients with immune-mediated inflammatory diseases: Insight from the large-scale Italian VALORE project

Article

作者: Rossi, Paola ; Carta, Paolo ; Massari, Marco ; Trama, Ugo ; Senesi, Ilenia ; Belleudi, Valeria ; Spini, Andrea ; Costa, Giorgio ; Carollo, Massimo ; Soardo, Federica ; Lopes, Sara ; Scarpelli, Rita Francesca ; Balducci, Francesco ; Mangano, Antea Maria Pia ; De Sarro, Giovambattista ; Gini, Rosa ; Bucaneve, Giampaolo ; Spila Alegiani, Stefania ; Bellitto, Chiara ; Bernardi, Francesca Futura ; Gallizzi, Romina ; Ejlli, Lucian ; Urru, Silvana Anna Maria ; Scapin, Angela ; Ingrasciotta, Ylenia ; Trifirò, Gianluca ; Da Cas, Roberto ; Tuccori, Marco ; Puccini, Aurora ; Ledda, Stefano ; Mazzone, Arianna ; Cavazzana, Anna ; Ancona, Domenica ; Sorrentino, Carla ; Pellegrini, Giorgia ; L'Abbate, Luca ; Allotta, Alessandra ; Stella, Paolo ; Leoni, Olivia ; Pollina, Sebastiano Addario ; Mathieu, Clément ; Sapigni, Ester ; Campomori, Annalisa

Real-world data on biological drug use in pediatric patients with immune-mediated inflammatory diseases (IMIDs) are scarce. This retrospective, population-based, cohort study aimed to provide an overview of biological drug use among children and adolescents with IMIDs from 2010 to 2023 using the Italian VALORE distributed database network. As secondary aim, potential of such a network for evaluating the risk of serious infections related to biological drugs in pediatrics was investigated. The yearly prevalence of use of biological drugs in IMID pediatric patients was calculated. Among incident users, persistence to adalimumab, etanercept, infliximab, golimumab, tocilizumab, secukinumab, and abatacept was measured. A sample power analysis to estimate the person-years of exposure required to investigate the association with the risk of serious infection and individual biological drug was performed. The yearly prevalence of biological drug use increased over time (+427.3 %), and it was consistently higher among females than males and among 12-17-year-olds than younger children. A total of 6222 incident biological drug users were identified, with a median follow-up of 3.8 years, and juvenile idiopathic arthritis (JIA, 35.9 %) and inflammatory bowel diseases (IBDs, 35.9 %) were the most common indications for use. After one year from the treatment start, more than 70 % of JIA patients using either adalimumab or etanercept were still on treatment, while persistence rates in IBDs were lower (ranging from 57.4 % to 65.0 %). Findings of this study show the potential of the VALORE network to provide enough exposure data to investigate the risk of serious infections for adalimumab, etanercept, and infliximab.

2025-08-01·Blood Neoplasia

A novel cereblon variant with both exon 8 and 10 deletions in newly diagnosed and relapsed multiple myeloma

Article

作者: Chesi, Marta ; Zhu, Yuan Xiao ; Arribas, Mariano ; Bruins, Laura ; Polavarapu, Abhigna ; Dutta, Soumya ; Chapman, Jonathan ; Chen, Xianfeng ; Ahmann, Gregory J ; Bergsagel, P Leif ; Lopez, Isaac ; Rimsza, Lisa M ; Fonseca, Rafael ; Singharoy, Abhishek

Acquisition of drug resistance, particularly to immunomodulatory drugs (IMiDs) in multiple myeloma (MM), is an important challenge in patient treatment. IMiDs are the canonical molecular glue that bind to cereblon (CRBN) and redirect its E3 ubiquitin ligase activity to neo-substrates, such as IKZF1/IFZF3. Genetic changes in the CRBN gene have been associated with IMiD resistance, including the exon 10-spliced CRBN transcripts that increase in incidence in parallel with IMiD-refractory states. Herein, we designed a new probe against CRBN splice isoform to detect exon 10 deletion and validated the variant expression using NanoString and messenger RNA (mRNA) sequencing analysis. We analyzed 74 MM samples, including 28 cases of newly diagnosed MM and 46 cases of relapsed and end-stage MM. Four cases were identified with 40% exon 10-deleted mRNA as compared with total CRBN mRNA (1 from newly diagnosed, 3 from relapsed and end-stage). Sequencing of complementary DNAs from 2 samples unexpectedly demonstrated additional deletion of exon 8. Extensive molecular-modeling and coimmunoprecipitation studies identified the mechanisms of CRBN dysfunction in protein structures, including impact on the interaction between CRBN with the E3 ligase machinery on deletion of exon 8 or dual deletion of exons 8 and 10. In summary, we developed a feasible approach to detect exon 10-deleted CRBN isoform on a gene expression platform and unexpectedly identified a variant with alterations of exon 10 and 8 transcripts in both newly diagnosed and refractory cases. This variant is present at diagnosis and could have separate, yet likely additive, effects on drug resistance.

867

项与泊马度胺相关的新闻（医药）

2025-07-23

·Firstwordpharma

FDA pushes back verdict on GSK's Blenrep by three months

The FDA has extended its review of GSK's Blenrep (belantamab mafodotin) combinations for earlier-line multiple myeloma treatment, just days after an advisory committee voted against the drug's benefit-risk profile at the proposed dose in two indications. Originally expected to render its verdict by today, GSK said the agency has now pushed the date back three months to October 23, giving it "time to review additional information provided" by the company.Last week, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 5-3 and 7-1 against Blenrep-based combinations with bortezomib and Pomalyst (pomalidomide), respectively. Panelists cited concerns over ocular toxicities and unresolved questions around optimal dosing – issues that have dogged the BCMA-targeting antibody-drug conjugate since its initial approval.Blenrep was originally granted accelerated approval as a fifth-line monotherapy back in 2020, but was later voluntarily withdrawn after failing a confirmatory study. The current application is based on the Phase III DREAMM-7 and DREAMM-8 trials, which tested the drug in combination with standard backbone therapies in patients who had received at least one prior line of treatment. Both trials demonstrated statistically significant improvements in progression-free survival, and in the case of DREAMM-7, an overall survival benefit versus a Darzalex (daratumumab)-based regimen.In its comeback, Blenrep combinations have already secured approvals this year in the UK and Japan, with clearance in the EU expected shortly. However, FDA briefing documents released ahead of the ODAC meeting last week suggested GSK may face a rockier path to reintroducing Blenrep in the US, due in part to ongoing concerns over ocular toxicity that have not been observed with other approved multiple myeloma treatments.GSK has argued that physicians have become more adept at managing Blenrep's ocular side effects and that the drug fills an important treatment gap not fully met by CAR-T therapies or bispecific antibodies (see – Spotlight On: Blenrep facing adcom déjà vu but GSK is coming prepared).On Wednesday, the company said it is "confident in the data supporting Blenrep combinations and looks forward to ongoing constructive conversations with the FDA as they continue their review."

加速审批临床3期上市批准

2025-07-21

·氨基观察

“疗效不是一切”，来自GSK的ADC警示

氨基观察-创新药组原创出品作者 | 郑晓“疗效数据很强，但毒性数据也非常强”。7月17日，FDA肿瘤药物咨询委员会（ODAC），拒绝批准葛兰素史克的 BCMA ADC 药物Blenrep用于二线联合治疗复发性或难治性多发性骨髓瘤。其中最引发关注的，便是其毒性问题。虽然ODAC的意见并不能完全左右FDA，但Blenrep的前景充满了新变数。原本，它大概率能成为ADC领域的一段佳话。2022年11月，Blenrep因确证性III期试验失败而黯然退市。但仅时隔两年半，Blenrep便凭借联合疗法头对头战胜标准三联疗法的成绩卷土重来。两项关键III期试验（DREAMM-7和DREAMM-8）的胜利，重新证明了其临床价值。鉴于不错的临床结果，GSK信心满满。今年4月，公司首席商务官uke Miels认为Blenrep的销售峰值将突破38亿美元，甚至指出其目标是替代年销售额超百亿美元的达雷妥尤单抗。若一切顺利，FDA将在2025年7月23日之前就该药物的潜在批准做出最终决定。但眼下的新变数，无疑在提醒GSK：现实永远比理想残酷。这也给火热的ADC领域提了个醒：疗效并非一切。/ 01 /GSK的底气原本，两项III期临床DREAMM-7、DREAMM-8，让GSK无比乐观。具体来说，在DREAMM-7试验中，与达雷妥尤单抗联合硼替佐米加地塞米松疗法（BVd）相比，Blenrep联合BVd疗法的中位PFS几乎增加了两倍（36.6个月vs 13.4个月），该联合疗法将死亡风险降低了42%，三年生存率为74%，对照组为60%。在DREAMM-8试验中，错过了OS终点，但Blenrep联合泊马度胺加地塞米松（BPd），对比硼替佐米联合BPd，在近21.8个月中位随访中，Blenrep联合治疗组的中位PFS（未达到）优于对照组（12.7个月）。基于DREAMM-7、DREAMM-8结果，GSK认为，Blenrep不仅上岸在即，在短期可能会成为一款超级重磅炸弹，并且在远期重新定义r/rMM的治疗。这指向一个更为远大的目标，那就是取代强生的达雷妥尤单抗。DREAMM-7、DREAMM-8试验成功后，GSK于2024年11月启动了DREAMM-10研究，将Blenrep联合来那度胺和地塞米松对阵达雷妥尤单抗+来那度胺+地塞米松这一黄金方案。GSK信心十足，“在那里，我们只需要制定剂量和给药周期设计”，Luke Miels表示。但对于ADC药物来说，需要关注的显然不只有疗效。/ 02 /“疗效数据很强，但毒性数据也非常强”ODAC的态度与GSK呈现出鲜明对立，这一结果恐怕出乎所有人的意料。此前在市场看来，唯一可能存疑的是DREAMM-8试验（因错失总生存期OS终点），而 DREAMM-7获得认可几乎是板上钉钉。但ODAC的最终投票结果显示，DREAMM-7与DREAMM-8的试验结果均未获得全面认可。一方面，这与入组患者的种群构成有关——两项临床试验中美国受试者的比例均不超过 5%，这一点遭到了重点质疑。但更关键的原因，仍在于安全性问题。Blenrep的毒性问题早已是公开的隐患，尤其是眼毒性，这在DREAMM-7与DREAMM-8两项试验中体现得尤为突出。角膜内皮炎（KVA）事件不仅发生率高，严重程度也令人担忧：DREAMM-7和DREAMM-8 中，分别有77%和78%的患者出现过3-4级KVA事件。此外，尽管眼部毒性理论上可通过延长输注间隔、减少剂量等方式进行管理，但实际恢复情况并不理想——KVA事件的复发率高，且恢复周期漫长。综合来看，DREAMM-7与DREAMM-8中患者对预设剂量的耐受性较差：到了第三治疗周期，两项试验中超过半数的患者已无法按预定剂量接受治疗。正如一位委员会成员特别指出的：虽然葛兰素史克提供的疗效数据“很强”，但毒性数据 “同样非常强”，因此他投下了反对票。/ 03 /疗效不是一切ODAC虽无法完全左右FDA的最终决定，却已为ADC领域敲响警钟：疗效并非唯一标尺，在疗效与安全性之间找到精准平衡，才是药物研发的核心逻辑。具体到Blenrep，其毒性问题与药物特性深度绑定。尽管BCMA靶点不在人体眼部表达，但研究已证实，Blenrep可通过巨胞饮作用被角膜上皮细胞摄取，进而诱发眼部毒性——而角膜上皮细胞更新速度快，对药物毒性本就更为敏感。事实上，GSK 原本有机会规避这一风险。据FDA透露，双方曾就此长期存在分歧：FDA曾建议让更多患者接受低剂量 Blenrep 治疗，认为低剂量或许能缓解眼部毒性问题。但GSK并不认同这一方案，认为低剂量带来的安全获益相对有限，且坚持“高起始剂量是诱导深度缓解的关键”，主张后续若有必要再降低剂量以减少毒性。因为GSK认为这些眼部毒性事件可控，且未必会导致长期视力丧失。正是这种对风险的侥幸心理，让GSK错失了测试更低剂量的机会，也可能因此失去了翻盘的关键筹码。尽管Blenrep的最终命运尚未可知，但这一事件已足够让整个行业警醒。毕竟，毒性过大本就是ADC药物的通病。因靶点介导的递送特性、载荷的细胞毒性强度、连接子稳定性不足等原因，ADC药物极易陷入毒性失控的困境。而当下，在 ADC 研发的热潮中，部分药企为迎合市场热度，可能过度追求疗效数据的亮眼，却忽视了安全性与疗效的平衡。短期内，这种倾向或许能催生风口，但从长远来看，无疑是埋下隐患。PS：欢迎扫描下方二维码，添加氨基君微信号交流。

临床3期抗体药物偶联物临床结果临床失败临床2期

2025-07-21

·CPHI制药在线

监管重拳！FDA专家委员会接连否决骨髓瘤、PTSD两大“明星新药”

关注并星标CPHI制药在线两天，两个领域，两场否决。7月17日至18日，美国FDA的两个专家咨询委员会接连对两款备受期待的新药投下反对票。多发性骨髓瘤与创伤后应激障碍的患者原本已经看见一线新机，却又被按下了暂停键。7月17日，肿瘤药物咨询委员会（ODAC）以5:3和7:1的投票结果，反对推荐葛兰素史克的抗体偶联药物玛贝兰妥单抗（belantamab mafodotin）两种联合方案用于复发或难治性多发性骨髓瘤患者。7月18日，精神药物咨询委员会（PDAC）以压倒性的10:1票数，反对大冢制药的布瑞哌唑（brexpiprazole）联合舍曲林治疗创伤后应激障碍（PTSD）的有效性。短短48小时内，两个不同治疗领域的"明星药物"相继遭遇监管挫折。故事背后却是同一道考题：到底怎样才算"够好"？玛贝兰妥单抗：眼毒性的阴影这款BCMA靶向ADC的经历像过山车：2020年凭单药五线治疗拿到加速批准，2022年确证性试验DREAMM-3折戟，全球撤市；如今GSK带着"组合拳"卷土重来，却还是撞了墙。DREAMM-7和DREAMM-8研究数据表面风光无限，无论联用硼替佐米还是泊马度胺，均显著延长无进展生存期（PFS），甚至DREAMM-7还显示出总生存期（OS）获益。然而FDA审评员的目光穿透了疗效光环，聚焦在两个刺眼的"高"字上：高比例眼部毒性（79%-89%）和高频率剂量调整（超50%患者需减量或延迟给药）。角膜病变临床表现为视力模糊、干眼乃至角膜溃疡，直接影响患者生活质量的毒性让委员会难以接受，更根本的问题是剂量困境，超过半数患者在第三治疗周期前就因毒性需要调整剂量。地域代表性缺陷雪上加霜，两项试验中美国患者比例均低于5%，触发部分委员强烈质疑全球数据对美国人群风险收益评估的外推可行性，在肿瘤药物审评日益强调真实世界代表性的今天，这一短板被无限放大。唯一投出支持票的John DeFlice（患者代表）发出了不同声音:"关键问题在于一个无法治愈的恶性肿瘤又多了一种可及疗法"。患者群体的证词显示，他们愿意在滴眼液、减量管理下与眼毒性共处，只为多争取一些时间。布瑞哌唑：PTSD新药二十年突围，临门一脚被挡回精神领域的故事同样揪心。PTSD新药断档已超二十年，现有只有舍曲林和帕罗西汀两张"老面孔"，临床急需新方案，约1300万美国成人患者每年饱受侵入性记忆、回避行为和高警觉症状折磨。从表面数据看，布瑞哌唑联合舍曲林表现亮眼。去年12月发表于JAMA Psychiatry的III期研究显示，联合组CAPS-5量表评分改善19.2分，显著优于舍曲林单药组的13.6分（p<0.001）。所有关键次要终点均告捷，且因不良事件停药率仅3.9%，远低于对照组的10.2%。为何遭遇10:1的压倒性反对？ PDAC的质疑聚焦于有效性证据力度。尽管统计学显著，临床意义的量值是否足够？与现有心理治疗及其他超说明书用药相比优势几何？委员会还关注长期数据缺失问题，PTSD作为慢性易复发性疾病，10周试验难以评估持久获益。联合疗法的理论依据坚实：舍曲林提升5-羟色胺水平改善情绪焦虑，布瑞哌唑通过多巴胺和5-羟色胺系统多靶点调节，形成协同。尤其对共病抑郁的患者（占PTSD大多数），这一组合更具潜力。但从"数据阳性"到"临床价值认可"之间存在鸿沟。McIntyre教授曾评价此为PTSD领域"非常积极"的进展，但咨询委员会显然要求更高标准，当临床未满足需求迫切时，监管天平反而向证据强度倾斜。监管风向两款药物折戟折射出FDA专家委员会评审逻辑的深刻演变。对玛贝兰妥单抗这类曾撤市的药物，委员会展现出"二次验证"的严苛态度--单药失败后，联合方案需提供更完备的获益风险证据。剂量优化不足成为硬伤，ODAC明确表示:"多年研发中错失了探索不同剂量的机会"。这呼应了FDA在会前背景文件中强调的"拟议剂量未充分优化"。当超过半数患者无法耐受目标剂量时，所谓"推荐方案"的临床可行性自然遭质疑。真实世界代表性成为新焦点。"这是美国FDA，拟议患者人群是美国患者。临床开发项目几乎未纳入美国患者，无法评估美国人群的获益风险特征。"斯普拉特教授的发言代表委员会对全球化试验设计的反思。在肿瘤治疗反应可能受遗传背景、医疗实践影响的当下，地域数据失衡触发现实警报。对布瑞哌唑，PDAC则传递精神领域的新标准：症状改善需超越统计学意义，达到临床意义阈值。尽管CAPS-5评分5.6分的差异具有统计学显著性，但委员会可能质疑其转化为患者功能改善的实际价值。同时，作为"起始治疗方案"的定位遭遇挑战--是否所有患者起始即需联合治疗？还是应阶梯使用？药企下一步：换道、补课、再出发面对挫折，两家药企展现出韧性。GSK声明"充满信心，继续与FDA密切合作"，大冢制药同样表示"期待最终审批决定"。但务实策略已在推进。GSK可能双线并行：短期内转向欧洲市场寻求现金流（英国、日本、瑞士已批准联合方案）；同时补做剂量探索和美国人群研究。布瑞哌唑的路径更复杂，FDA最终裁决虽未至，但10:1票差预示艰难前景。可能的调整包括：补长期随访、精准锁定伴抑郁的PTSD亚群、再探更低剂量（现有2-3 mg/日是否过高）。中国市场方面，玛贝兰妥单抗的联合方案正在中国审评，而国产BCMA ADC紧随其后，GSK的跟头提醒后来人：高活性payload的窄安全窗，必须在早期就系好安全带。布瑞哌唑在华布局已展开，浙江萧山医院正在筹备生物等效性试验（CTR20251773），显示大冢对中国市场的重视。若美国获批遇阻，亚洲市场可能成为其重点。行业启示：创新药的"有效"与"可及"再平衡安全窗宽度决定ADC成败，玛贝兰妥单抗的角膜毒性非孤例，含MMAF的ADC均存在类似风险。当国产BCMA ADC快速推进时，需在早期研究中系统评估眼毒性机制，建立预防监测体系，避免"上市即受限"困境。联合治疗的增效逻辑需临床价值支撑。布瑞哌唑联合舍曲林虽优于单药，但委员会质疑其相对现有疗法的绝对优势。这提示企业：单纯"统计学显著"已不足，需证明临床意义差异，如功能恢复、生活质量提升等硬终点。剂量优化前移至早期研发刻不容缓。ODAC对玛贝兰妥单抗的否决核心在于"拟议剂量未充分优化"。现代肿瘤药研发需在I/II期探索更灵活剂量方案，而非固守传统"最大耐受剂量"模式。患者多样性纳入成关键。玛贝兰妥单抗试验中美国患者不足5%直接导致部分委员反对。全球化开发需平衡地域代表性，尤其是针对主要市场设计充分的亚组分析。GSK和大冢制药尚未放弃。前者寄望于7月23日的FDA最终裁决可能出现反转，后者将继续完善PTSD的临床证据链。两款药物的命运最终取决于一个核心问题：当疗效与安全性在天平两端摇摆，监管机构与临床医生是否愿意在严格管理下接受"不完美的选择"？END来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

抗体药物偶联物临床3期申请上市优先审批加速审批

100 项与泊马度胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08976	泊马度胺	L04AX06	DB08910

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
卡波西肉瘤	美国	Bristol Myers Squibb Co.	2020-05-14
难治性多发性骨髓瘤	澳大利亚	Celgene Pty Ltd.	2014-07-01
复发性多发性骨髓瘤	澳大利亚	Celgene Pty Ltd.	2014-07-01
多发性骨髓瘤	美国	Bristol Myers Squibb Co.	2013-02-08

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
原发性骨髓纤维化	临床3期	美国	Celgene Corp.	2010-09-08
原发性骨髓纤维化	临床3期	中国	Celgene Corp.	2010-09-08
原发性骨髓纤维化	临床3期	日本	Celgene Corp.	2010-09-08
原发性骨髓纤维化	临床3期	澳大利亚	Celgene Corp.	2010-09-08
原发性骨髓纤维化	临床3期	奥地利	Celgene Corp.	2010-09-08
原发性骨髓纤维化	临床3期	比利时	Celgene Corp.	2010-09-08
原发性骨髓纤维化	临床3期	加拿大	Celgene Corp.	2010-09-08
原发性骨髓纤维化	临床3期	法国	Celgene Corp.	2010-09-08
原发性骨髓纤维化	临床3期	德国	Celgene Corp.	2010-09-08
原发性骨髓纤维化	临床3期	意大利	Celgene Corp.	2010-09-08

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临床结果

适应症

分期

评价

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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


NCT03713294 (CTgov)	临床2期	难治性多发性骨髓瘤	37	elotuzumab+dexamethasone+pomalidomide	範襯簾衊蓋積顧簾窪憲 = 願鑰鑰鑰鏇餘襯醖壓淵蓋遞蓋夢壓範衊願壓築 (築範壓廠壓鏇顧遞製夢, 鬱鹹衊鹽製製糧醖築構 ~ 選夢鬱構糧蓋壓製衊顧) 更多	-	2025-06-24
NCT04941937 (Pubmed \| Onco Targets Ther)	临床2期	复发性多发性骨髓瘤 Exportin 1 (XPO1)	21	Selinexor 60 mg	網網壓顧簾製積繭觸淵(願願鏇膚鏇遞廠願簾淵) = 餘膚築衊選蓋鹽廠鑰淵夢糧願獵觸簾醖醖鏇獵 (鏇獵網顧鹽簾願積獵遞 ) 更多	积极	2025-06-01
				Selinexor 40 mg	網網壓顧簾製積繭觸淵(願願鏇膚鏇遞廠願簾淵) = 廠鹽遞觸糧衊衊壓鬱膚夢糧願獵觸簾醖醖鏇獵 (鏇獵網顧鹽簾願積獵遞 ) 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	齋艱築鹽夢鏇蓋鹽觸願(顧淵願壓遞構積製選壓) = 繭襯選積鏇淵夢壓顧齋蓋製鏇餘艱觸廠顧憲夢 (齋鹽築衊簾廠艱鏇窪鏇 ) 更多	积极	2025-05-30
				Selinexor 60 mg + Pomalidomide 4 mg + Dexamethasone	齋艱築鹽夢鏇蓋鹽觸願(顧淵願壓遞構積製選壓) = 憲艱鏇醖範艱積夢糧窪蓋製鏇餘艱觸廠顧憲夢 (齋鹽築衊簾廠艱鏇窪鏇 )
NCT04484623 (DREAMM-8, EHA2025)	临床3期	复发性多发性骨髓瘤 minimal residual disease negativity	302	Belantamab Mafodotin, Pomalidomide, and Dexamethasone	鹹範餘鑰齋積廠膚繭糧(襯遞醖鹽鏇簾範齋齋繭) = 壓築築齋淵廠鹹淵壓簾鏇衊餘蓋觸構淵鏇鏇齋 (窪鬱製鑰簾夢艱壓鏇淵 )	积极	2025-05-22
				Pomalidomide, Bortezomib, and Dexamethasone	鹹範餘鑰齋積廠膚繭糧(襯遞醖鹽鏇簾範齋齋繭) = 繭簾顧網憲衊顧糧選廠鏇衊餘蓋觸構淵鏇鏇齋 (窪鬱製鑰簾夢艱壓鏇淵 )
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)	築鏇選網鏇網窪艱鏇憲(糧艱齋範顧鏇壓蓋繭鬱) = 鏇淵糧選齋觸夢壓夢艱顧鹽淵製範簾觸築鹹壓 (夢廠艱積繭積鹹簾構積, 鏇廠範選選膚憲構遞觸 ~ 淵獵餘繭構鹽獵鏇糧顧) 更多	-	2025-05-20
				Autoleucel [Cilta-cel]+JNJ-68284528 (Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]))	築鏇選網鏇網窪艱鏇憲(糧艱齋範顧鏇壓蓋繭鬱) = 鹽範蓋淵衊餘膚構鹹襯顧鹽淵製範簾觸築鹹壓 (夢廠艱積繭積鹹簾構積, 網網遞網廠艱壓餘觸淵 ~ 醖觸觸窪襯網鏇願憲鬱) 更多
NCT05432414 (POM-MM-003, EHA2025)	临床2期	肾脏损伤	82	Pomalidomide, Bortezomib, Dexamethasone (PVD)	簾憲餘網膚獵壓鬱鏇壓(遞鬱膚簾鑰獵顧餘網鹽) = Adverse events (AEs) were reported in 48 (82.76%) of 58 pts with PVd (50% at severity of grade ≥3) versus 16 (66.67%) of 24 pts with Vd (29.17% at severity of grade ≥3). The most common any-grade AEs were peripheral neuropathy (n=13) in the PVd group and peripheral neuropathy (n=10) in the Vd group. In the PVd group, thrombotic events and rashes were reported in 7 (12.07%) and 8 (13.79%) of 58 pts, respectively. 構膚糧醖範齋遞膚蓋廠 (淵齋鬱築繭鹹遞構範製 )	积极	2025-05-14
				Bortezomib, Dexamethasone (VD)
PB3000 (EHA2025)	N/A	多发性骨髓瘤维持	28	Pomalidomide 4mg/day	鬱鑰衊憲鏇壓網築築獵(繭廠顧網醖衊鑰衊願獵) = 構鏇鹽獵選繭蓋襯壓襯糧鹽鹽淵膚遞鏇夢壓簾 (淵廠繭廠鬱鏇窪鑰襯壓, 37.6 ~ 50.0) 更多	积极	2025-05-14
PB2931 (EHA2025)	N/A	复发性多发性骨髓瘤 Fluorescence in situ hybridization(FISH)	221	DPd	顧積廠簾艱選構願選製(膚夢夢餘構餘蓋淵鬱糧) = 憲夢齋鬱積壓窪簾觸蓋簾積構積窪鏇顧構簾艱 (鹹鏇顧鹹鑰蓋鏇襯廠憲 ) 更多	积极	2025-05-14
				VPd	積簾鏇鬱製淵簾淵簾蓋(構鹹憲觸簾餘窪範繭壓) = 鏇構壓蓋衊遞鏇繭廠繭構繭憲鏇繭積艱構糧鹹 (襯淵醖積鑰廠觸遞鹹鹹 )
PF763 (EHA2025)	N/A	免疫球蛋白轻链淀粉样变性 CD38	28	Isatuximab-Pomalidomide-Dexamethasone	鏇鑰糧鬱積齋齋餘網衊(蓋鹹製鏇鏇窪願糧遞遞) = 11.8% 鹹糧範鏇鏇遞憲鹹範積 (膚夢窪顧衊衊網鑰窪構 ) 更多	积极	2025-05-14
PB2989 (EHA2025)	N/A	复发性多发性骨髓瘤	100	Carfilzomib, Pomalidomide, Dexamethasone	鏇顧網醖構遞艱築淵繭(構繭襯鬱憲蓋壓築餘觸) = 齋壓窪構襯顧餘積積窪鹽鹹鏇簾顧築遞鹽選糧 (製積淵醖艱蓋膚壓鏇獵 ) 更多	积极	2025-05-14
				Daratumumab+Carfilzomib, Pomalidomide, Dexamethasone	鏇顧網醖構遞艱築淵繭(構繭襯鬱憲蓋壓築餘觸) = 觸鬱艱鹽鬱網鏇獵繭糧鹽鹹鏇簾顧築遞鹽選糧 (製積淵醖艱蓋膚壓鏇獵 )