Daratumumab 的研究
3b 期、多中心、开放标签、Daratumumab 长期扩展研究
The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma benefiting from treatment in certain Janssen Research and Development (R&D) studies that use daratumumab as part of the study treatment regimen: access for all participants regardless of treatment group in daratumumab studies and access to participants in daratumumab-containing arms in the non-daratumumab studies will be allowed from studies which have reached clinical cutoff for final analysis. Certain long-term safety data will continue to be collected from study participants.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Beijing、中国、100044
- Peking University People's Hospital
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Beijing、中国、100034
- Peking University First Hospital
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Beijing、中国、100020
- Beijing Chaoyang Hospital
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Beijing、中国、100006
- Peking Union Medical College Hospital
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Changchun、中国、130021
- The First Bethune Hospital of Jilin University
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Chengdu、中国、610041
- West China Hospital Si Chuan University
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Fuzhou、中国、350001
- Fujian Medical University
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Guangzhou、中国、510080
- Guangdong General Hospital
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Guangzhou、中国、510515
- Nanfang Hospital
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Hangzhou、中国、310020
- First affiliated Hospital of Zhejiang University
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Hangzhou、中国、310020
- First Affiliated Hospital Medical School of Zhejiang University
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Shanghai、中国、200003
- Shanghai Changzheng Hospital
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Shanghai、中国、200127
- Renji Hospital, Shanghai Jiaotong University School of Medicine
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Shanghai、中国、200025
- Ruijin Hospital Shanghai Jiao Tong University
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Suzhou、中国、215002
- The First Affiliated Hospital of Soochow University
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Tianjin、中国、300320
- Institute of Hematology and Blood Diseases Hospital
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Tianjin、中国、300060
- Tianjin cancer hospital
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Wenzhou、中国、325000
- The First Affiliated Hospital of Wenzhou Medical University
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Zhengzhou、中国、450008
- Henan Cancer Hospital
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Aarhus N、丹麦、DK-8200
- Aarhus University Hospital
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Cherkasy、乌克兰、18009
- CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC
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Dnipro、乌克兰、49102
- Municipal Non-Commercial Enterprise City Clinical Hospital No 4 of Dnipro City Council
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Kharkiv、乌克兰、61070
- MNE Regional Oncology Center
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Vinnitsa、乌克兰、21018
- Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
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Moscow、俄罗斯、125284
- S.P. Botkin Moscow City Clinical Hospital
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Moscow、俄罗斯、125284
- S.P. Botkin Moscow City Clinical Hospital 1
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Nizhny Novgorod、俄罗斯、603126
- Nizhniy Novgorod Region Clinical Hospital
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Petrozavodsk、俄罗斯、185019
- Republican Hospital named by V.A.Baranova
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Ryazan、俄罗斯、390003
- Ryazan Regional Clinical Hospital
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Saint Petersburg、俄罗斯、191024
- Clinical Research Institute of Hematology and Transfusiology
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Saint Petersburg、俄罗斯、198205
- City Hospital No.15
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Saratov、俄罗斯、410012
- Saratov State Medical University
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Syktyvkar、俄罗斯、167904
- Oncology Dispensary of Komi Republic
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Izmir、土耳其（türkiye）、35100
- Ege Universitesi Tip Fakultesi
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Campinas、巴西、13083-888
- Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
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Natal、巴西、59062 000
- Liga Norte Riograndense Contra O Cancer
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Porto Alegre、巴西、90610-000
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
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Rio de Janeiro、巴西、20230-130
- Ministerio da Saude Instituto Nacional do Cancer
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Rio de Janeiro、巴西、22775 001
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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São Paulo、巴西、04537 081
- Clinica Medica Sao Germano LTDA
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São Paulo、巴西、01323 010
- Real e Benemerita Associacao Portuguesa de Beneficencia
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Athens Attica、希腊、115 28
- Alexandra General Hospital of Athens
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Chemnitz、德国、09113
- Klinikum Chemnitz gGmbH
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Hamburg、德国、22763
- Asklepios Klinik Altona
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Tübingen、德国、72076
- Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
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Roma、意大利、00133
- Universita Degli Studi di Roma Tor Vergata
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Roma、意大利、00161
- Sapienza University of Rome
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Brno、捷克语、62500
- Fakultni nemocnice Brno
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Pilsen、捷克语、304 60
- Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni (Main)
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Prague、捷克语、128 08
- Všeobecná fakultní nemocnice v
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Antwerp、比利时、2030
- ZAS Cadix
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Caen、法国、14033
- Centre Hospitalier Universitaire (CHU) de Caen
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Nantes、法国、44000
- CHU Nantes
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Paris、法国、75010
- Hopital Saint Louis
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Pessac、法国、33604
- Hopital Haut Leveque
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Legnica、波兰、59-220
- Wojewodzki Szpital Specjalistyczny w Legnicy
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Poznan、波兰、60-569
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Florida
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Miami、Florida、美国、33136
- University of Miami Sylvester Cancer Center
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Georgia
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Atlanta、Georgia、美国、30322
- Emory University
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Michigan
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Ann Arbor、Michigan、美国、48109
- University of Michigan Comprehensive Cancer Center
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Missouri
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St Louis、Missouri、美国、63108
- Barnes-jewish Hospital
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New York
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New York、New York、美国、10065
- Memorial Sloan Kettering Cancer Center
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New York、New York、美国、10029
- Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
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Texas
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Dallas、Texas、美国、75246
- Baylor University Medical Center
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Leeds、英国、LS9 7TF
- St James University Hospital
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Leicester、英国、LE1 5WW
- Leicester Royal Infirmary Haematology
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Surrey、英国、SM2 5PT
- Royal Marsden Hospital
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Wolverhampton、英国、WV10 0QP
- New Cross Hospital
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Alcorcón、西班牙、28922
- Hosp. Univ. Fundacion Alcorcon
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Badalona、西班牙、08916
- Hosp. Univ. Germans Trias I Pujol
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Barcelona、西班牙、08003
- Hosp. Del Mar
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Barcelona、西班牙、08036
- Hosp Clinic de Barcelona
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L'Hospitalet de Llobregat、西班牙、08908
- Inst. Cat. Doncologia-H Duran I Reynals
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Madrid、西班牙、28041
- Hosp. Univ. 12 de Octubre
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Madrid、西班牙、28034
- Hosp. Univ. Ramon Y Cajal
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Madrid、西班牙、28007
- Hosp. Gral. Univ. Gregorio Maranon
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Madrid、西班牙、28027
- Clinica Univ. de Navarra 1
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Madrid、西班牙、28050
- Centro Integral Oncológico Clara Campal
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Murcia、西班牙、30008
- Hosp. Gral. Univ. J.M. Morales Meseguer
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Pamplona、西班牙、31008
- Clinica Univ. de Navarra
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Pozuelo de Alarcón、西班牙、28223
- Hosp. Quiron Madrid Pozuelo
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Salamanca、西班牙、37007
- Hosp Clinico Univ de Salamanca
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San Cristóbal de La Laguna、西班牙、38320
- Hosp. Univ. de Canarias
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Terrassa、西班牙、08221
- Hosp. Mutua Terrassa
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Valencia、西班牙、46017
- Hosp. Univ. Dr. Peset
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Busan、韩国、49241
- Pusan National University Hospital
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Goyang-si、韩国、10408
- National Cancer Center
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Hwasun、韩国、519-800
- Chonnam National University Hwasun Hospital
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Seongnam、韩国、13620
- Seoul National University Bundang Hospital
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Seoul、韩国、03080
- Seoul National University Hospital
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Seoul、韩国、06351
- Samsung Medical Center
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Seoul、韩国、06591
- The Catholic University of Korea Seoul St Marys Hospital
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participants must be actively receiving daratumumab (either as monotherapy or in combination with other study treatment) in certain Janssen research and development (R&D) studies or receiving other study treatment in a Janssen R&D daratumumab study for participants with multiple myeloma or smoldering multiple myeloma which has reached clinical cutoff for final analysis continue to benefit from study treatment, not have experienced disease progression or unmanageable toxicity while receiving daratumumab, not have met the withdrawal criteria set forth in the parent study, and have had the last dose of study treatment within the previous 3 months
- Investigator's assessment that the benefit of continued study treatment will outweigh the risks
- A female participant of childbearing potential must have a negative pregnancy test at screening and must agree to further serum or urine pregnancy tests during the study
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 3 months after receiving the last dose of study treatment
- Must sign an informed consent form (ICF; or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
- Willing and able to adhere to the lifestyle restrictions specified in this protocol
Exclusion Criteria:
- Has taken any disallowed therapies or treatment for the disease under study between the completion of the parent study and the planned first dose of study treatment
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Known allergies, hypersensitivity, or intolerance to study treatments or their excipients (refer to the daratumumab investigator brochure (IB) and local country prescribing information for dexamethasone, carfilzomib, pomalidomide, and lenalidomide)
- Vaccinated with an investigational vaccine (except for Coronavirus disease [COVID-19])or live attenuated or replicating viral vector vaccines within 4 weeks prior to enrollment
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Daratumumab
Participants will receive a single dose of daratumumab 16 milligrams per kilograms (mg/kg) intravenous (IV) or 1800 mg subcutaneous (SC) infusion on Cycle 1 Day 1 (28-day cycle), as monotherapy or in combination with standards of care treatment (that is, pomalidomide and dexamethasone, lenalidomide and dexamethasone, carfilzomib and dexamethasone) or standards of care treatment alone, depending on the treatment received in the parent study. Participants who received daratumumab IV during the parent study, will have an option to switch to daratumumab SC on Day 1 of any cycle during this long-term extension study. |
Lenalidomide will be administered orally. Pomalidomide will be administered orally. Daratumumab will be administered either intravenously or subcutaneously.
其他名称：
Carfilzomib will be administered intravenously. Dexamethasone will be administered either orally or intravenously. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants with Serious Adverse Events (SAEs)
大体时间：3 years 7 months
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Number of participants with SAEs will be reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product. |
3 years 7 months
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Number of Participants with AEs of Special Interest (AESI)
大体时间：3 years 7 months
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Number of participants with AESI, that is, reactivation of HBV infection, will be reported. |
3 years 7 months
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Number of Participants with Pregnancies or Partner Pregnancies
大体时间：3 years 7 months
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Number of participants with pregnancies or partner pregnancies will be reported using the appropriate pregnancy notification form. |
3 years 7 months
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Number of Participants with Abnormal Pregnancies as SAE
大体时间：3 years 7 months
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Number of Participants with Abnormal Pregnancies as SAE will be reported. |
3 years 7 months
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合作者和调查者
调查人员
- 研究主任：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CR109200
- 2021-006494-33 (EudraCT编号)
- 2022-500138-27-00 (注册表标识符：EUCT number)
- 54767414MMY3030 (其他标识符：Janssen Research & Development, LLC)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.