ダラツムマブの研究
第 3b 相、多施設共同、非盲検、ダラツムマブの長期継続試験
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.
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Florida
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Miami、Florida、アメリカ、33136
- University of Miami Sylvester Cancer Center
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Emory University
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan Comprehensive Cancer Center
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Missouri
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St Louis、Missouri、アメリカ、63108
- Barnes-jewish Hospital
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New York
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New York、New York、アメリカ、10065
- Memorial Sloan Kettering Cancer Center
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New York、New York、アメリカ、10029
- Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
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Texas
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Dallas、Texas、アメリカ、75246
- Baylor University Medical Center
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Leeds、イギリス、LS9 7TF
- St James University Hospital
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Leicester、イギリス、LE1 5WW
- Leicester Royal Infirmary Haematology
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Surrey、イギリス、SM2 5PT
- Royal Marsden Hospital
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Wolverhampton、イギリス、WV10 0QP
- New Cross Hospital
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Roma、イタリア、00133
- Universita Degli Studi di Roma Tor Vergata
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Roma、イタリア、00161
- Sapienza University of Rome
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Cherkasy、ウクライナ、18009
- CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC
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Dnipro、ウクライナ、49102
- Municipal Non-Commercial Enterprise City Clinical Hospital No 4 of Dnipro City Council
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Kharkiv、ウクライナ、61070
- MNE Regional Oncology Center
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Vinnitsa、ウクライナ、21018
- Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
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Athens Attica、ギリシャ、115 28
- Alexandra General Hospital of Athens
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Alcorcón、スペイン、28922
- Hosp. Univ. Fundacion Alcorcon
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Badalona、スペイン、08916
- Hosp. Univ. Germans Trias I Pujol
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Barcelona、スペイン、08003
- Hosp. Del Mar
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Barcelona、スペイン、08036
- Hosp Clinic de Barcelona
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L'Hospitalet de Llobregat、スペイン、08908
- Inst. Cat. Doncologia-H Duran I Reynals
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Madrid、スペイン、28041
- Hosp. Univ. 12 de Octubre
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Madrid、スペイン、28034
- Hosp. Univ. Ramon Y Cajal
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Madrid、スペイン、28007
- Hosp. Gral. Univ. Gregorio Maranon
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Madrid、スペイン、28027
- Clinica Univ. de Navarra 1
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Madrid、スペイン、28050
- Centro Integral Oncológico Clara Campal
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Murcia、スペイン、30008
- Hosp. Gral. Univ. J.M. Morales Meseguer
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Pamplona、スペイン、31008
- Clinica Univ. de Navarra
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Pozuelo de Alarcón、スペイン、28223
- Hosp. Quiron Madrid Pozuelo
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Salamanca、スペイン、37007
- Hosp Clinico Univ de Salamanca
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San Cristóbal de La Laguna、スペイン、38320
- Hosp. Univ. de Canarias
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Terrassa、スペイン、08221
- Hosp. Mutua Terrassa
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Valencia、スペイン、46017
- Hosp. Univ. Dr. Peset
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Brno、チェコ、62500
- Fakultni nemocnice Brno
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Pilsen、チェコ、304 60
- Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni (Main)
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Prague、チェコ、128 08
- Všeobecná fakultní nemocnice v
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Aarhus N、デンマーク、DK-8200
- Aarhus University Hospital
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Izmir、トルコ（Türkiye）、35100
- Ege Universitesi Tip Fakultesi
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Chemnitz、ドイツ、09113
- Klinikum Chemnitz gGmbH
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Hamburg、ドイツ、22763
- Asklepios Klinik Altona
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Tübingen、ドイツ、72076
- Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
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Caen、フランス、14033
- Centre Hospitalier Universitaire (CHU) de Caen
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Nantes、フランス、44000
- CHU Nantes
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Paris、フランス、75010
- Hopital Saint Louis
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Pessac、フランス、33604
- Hopital Haut Leveque
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Campinas、ブラジル、13083-888
- Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
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Natal、ブラジル、59062 000
- Liga Norte Riograndense Contra O Cancer
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Porto Alegre、ブラジル、90610-000
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
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Rio de Janeiro、ブラジル、20230-130
- Ministerio da Saude Instituto Nacional do Cancer
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Rio de Janeiro、ブラジル、22775 001
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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São Paulo、ブラジル、04537 081
- Clinica Medica Sao Germano LTDA
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São Paulo、ブラジル、01323 010
- Real e Benemerita Associacao Portuguesa de Beneficencia
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Antwerp、ベルギー、2030
- ZAS Cadix
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Legnica、ポーランド、59-220
- Wojewodzki Szpital Specjalistyczny w Legnicy
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Poznan、ポーランド、60-569
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Moscow、ロシア、125284
- S.P. Botkin Moscow City Clinical Hospital
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Moscow、ロシア、125284
- S.P. Botkin Moscow City Clinical Hospital 1
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Nizhny Novgorod、ロシア、603126
- Nizhniy Novgorod Region Clinical Hospital
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Petrozavodsk、ロシア、185019
- Republican Hospital named by V.A.Baranova
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Ryazan、ロシア、390003
- Ryazan Regional Clinical Hospital
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Saint Petersburg、ロシア、191024
- Clinical Research Institute of Hematology and Transfusiology
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Saint Petersburg、ロシア、198205
- City Hospital No.15
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Saratov、ロシア、410012
- Saratov State Medical University
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Syktyvkar、ロシア、167904
- Oncology Dispensary of Komi Republic
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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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Busan、韓国、49241
- Pusan National University Hospital
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Goyang-si、韓国、10408
- National Cancer Center
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Hwasun、韓国、519-800
- Chonnam National University Hwasun Hospital
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Seongnam、韓国、13620
- Seoul National University Bundang Hospital
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Seoul、韓国、03080
- Seoul National University Hospital
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Seoul、韓国、06351
- Samsung Medical Center
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Seoul、韓国、06591
- The Catholic University of Korea Seoul St Marys Hospital
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
Carfilzomib will be administered intravenously. Dexamethasone will be administered either orally or intravenously. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants with Serious Adverse Events (SAEs)
時間枠：3 years 7 months
|
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)
時間枠：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
時間枠：3 years 7 months
|
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
時間枠：3 years 7 months
|
Number of Participants with Abnormal Pregnancies as SAE will be reported. |
3 years 7 months
|
協力者と研究者
捜査官
- スタディディレクター：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CR109200
- 2021-006494-33 (EudraCT番号)
- 2022-500138-27-00 (レジストリ識別子：EUCT number)
- 54767414MMY3030 (その他の識別子：Janssen Research & Development, LLC)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。