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| ID | Type | Description | Link |
|---|---|---|---|
| 54767414MMY3030 | Other Identifier | Janssen Research & Development, LLC | |
| 2021-006494-33 | EudraCT Number | ||
| 2022-500138-27-00 | Registry Identifier | EUCT number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daratumumab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daratumumab | Drug | Daratumumab will be administered either intravenously or subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Serious Adverse Events (SAEs) | 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 |
| Number of Participants with AEs of Special Interest (AESI) | Number of participants with AESI, that is, reactivation of HBV infection, will be reported. | 3 years 7 months |
| Number of Participants with Pregnancies or Partner Pregnancies | Number of participants with pregnancies or partner pregnancies will be reported using the appropriate pregnancy notification form. | 3 years 7 months |
| Number of Participants with Abnormal Pregnancies as SAE | Number of Participants with Abnormal Pregnancies as SAE will be reported. | 3 years 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Cancer Center | Active, not recruiting | Miami | Florida | 33136 | United States | |
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
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| Carfilzomib | Drug | Carfilzomib will be administered intravenously. |
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| Dexamethasone | Drug | Dexamethasone will be administered either orally or intravenously. |
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| Lenalidomide | Drug | Lenalidomide will be administered orally. |
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| Pomalidomide | Drug | Pomalidomide will be administered orally. |
|
| Emory University |
| Active, not recruiting |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Michigan Comprehensive Cancer Center | Active, not recruiting | Ann Arbor | Michigan | 48109 | United States |
| Barnes-jewish Hospital | Active, not recruiting | St Louis | Missouri | 63108 | United States |
| Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg | Completed | New York | New York | 10029 | United States |
| Memorial Sloan Kettering Cancer Center | Completed | New York | New York | 10065 | United States |
| Baylor University Medical Center | Completed | Dallas | Texas | 75246 | United States |
| ZAS Cadix | Active, not recruiting | Antwerp | 2030 | Belgium |
| UNICAMP | Active, not recruiting | Campinas | 13083-970 | Brazil |
| Liga Norte Riograndense Contra O Cancer | Active, not recruiting | Natal | 59062 000 | Brazil |
| Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS | Active, not recruiting | Porto Alegre | 90610-000 | Brazil |
| Ministerio da Saude Instituto Nacional do Cancer | Active, not recruiting | Rio de Janeiro | 20230-130 | Brazil |
| COI Clinicas Oncologicas Integradas | Active, not recruiting | Rio de Janeiro | 22793 080 | Brazil |
| Real e Benemerita Associacao Portuguesa de Beneficencia | Recruiting | São Paulo | 01323 010 | Brazil |
| Clinica Medica Sao Germano S/S LTDA | Active, not recruiting | São Paulo | 04537-081 | Brazil |
| Peking Union Medical College Hospital | Active, not recruiting | Beijing | 100006 | China |
| Beijing Chaoyang Hospital | Active, not recruiting | Beijing | 100020 | China |
| Peking University First Hospital | Completed | Beijing | 100034 | China |
| Peking University People's Hospital | Active, not recruiting | Beijing | 100044 | China |
| The First Bethune Hospital of Jilin University | Active, not recruiting | Changchun | 130021 | China |
| West China Hospital Si Chuan University | Active, not recruiting | Chengdu | 610041 | China |
| Fujian Medical University | Active, not recruiting | Fuzhou | 350001 | China |
| Guangdong General Hospital | Active, not recruiting | Guangzhou | 510080 | China |
| Nanfang Hospital | Active, not recruiting | Guangzhou | 510515 | China |
| First Affiliated Hospital Medical School of Zhejiang University | Active, not recruiting | Hangzhou | 310020 | China |
| First affiliated Hospital of Zhejiang University | Active, not recruiting | Hangzhou | 310020 | China |
| Shanghai Changzheng Hospital | Active, not recruiting | Shanghai | 200003 | China |
| Ruijin Hospital Shanghai Jiao Tong University | Active, not recruiting | Shanghai | 200025 | China |
| Renji Hospital, Shanghai Jiaotong University School of Medicine | Active, not recruiting | Shanghai | 200127 | China |
| The First Affiliated Hospital of Soochow University | Active, not recruiting | Suzhou | 215002 | China |
| Tianjin cancer hospital | Completed | Tianjin | 300060 | China |
| Institute of Hematology and Blood Diseases Hospital | Active, not recruiting | Tianjin | 300320 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Active, not recruiting | Wenzhou | 325000 | China |
| Henan Cancer Hospital | Completed | Zhengzhou | 450008 | China |
| Fakultni nemocnice Brno | Active, not recruiting | Brno | 62500 | Czechia |
| Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni (Main) | Active, not recruiting | Pilsen | 304 60 | Czechia |
| Všeobecná fakultní nemocnice v | Active, not recruiting | Prague | 128 08 | Czechia |
| Aarhus University Hospital | Completed | Aarhus N | DK-8200 | Denmark |
| Centre Hospitalier Universitaire (CHU) de Caen | Completed | Caen | 14033 | France |
| CHU Nantes | Completed | Nantes | 44000 | France |
| Hopital Saint Louis | Active, not recruiting | Paris | 75010 | France |
| Hopital Haut Leveque | Completed | Pessac | 33604 | France |
| Klinikum Chemnitz gGmbH | Active, not recruiting | Chemnitz | 09113 | Germany |
| Asklepios Klinik Altona | Active, not recruiting | Hamburg | 22763 | Germany |
| Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II, | Completed | Tübingen | 72076 | Germany |
| Alexandra General Hospital of Athens | Active, not recruiting | Athens Attica | 115 28 | Greece |
| Universita Degli Studi di Roma Tor Vergata | Completed | Roma | 00133 | Italy |
| Sapienza University of Rome | Completed | Roma | 00161 | Italy |
| Wojewodzki Szpital Specjalistyczny w Legnicy | Active, not recruiting | Legnica | 59-220 | Poland |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Active, not recruiting | Poznan | 60-569 | Poland |
| S.P. Botkin Moscow City Clinical Hospital 1 | Active, not recruiting | Moscow | 125284 | Russia |
| S.P. Botkin Moscow City Clinical Hospital | Active, not recruiting | Moscow | 125284 | Russia |
| Nizhniy Novgorod Region Clinical Hospital | Active, not recruiting | Nizhny Novgorod | 603126 | Russia |
| Republican Hospital named by V.A.Baranova | Active, not recruiting | Petrozavodsk | 185019 | Russia |
| Ryazan Regional Clinical Hospital | Active, not recruiting | Ryazan | 390003 | Russia |
| Clinical Research Institute of Hematology and Transfusiology | Active, not recruiting | Saint Petersburg | 191024 | Russia |
| City Hospital No.15 | Active, not recruiting | Saint Petersburg | 198205 | Russia |
| Saratov State Medical University | Active, not recruiting | Saratov | 410012 | Russia |
| Oncology Dispensary of Komi Republic | Active, not recruiting | Syktyvkar | 167904 | Russia |
| Pusan National University Hospital | Active, not recruiting | Busan | 49241 | South Korea |
| National Cancer Center | Active, not recruiting | Goyang-si | 10408 | South Korea |
| Chonnam National University Hwasun Hospital | Active, not recruiting | Hwasun | 519-800 | South Korea |
| Seoul National University Bundang Hospital | Active, not recruiting | Seongnam | 13620 | South Korea |
| Seoul National University Hospital | Active, not recruiting | Seoul | 03080 | South Korea |
| Samsung Medical Center | Active, not recruiting | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul St Marys Hospital | Active, not recruiting | Seoul | 06591 | South Korea |
| Hosp. Univ. Fundacion Alcorcon | Active, not recruiting | Alcorcón | 28922 | Spain |
| Hosp. Univ. Germans Trias I Pujol | Active, not recruiting | Badalona | 08916 | Spain |
| Hosp. Del Mar | Active, not recruiting | Barcelona | 08003 | Spain |
| Hosp Clinic de Barcelona | Active, not recruiting | Barcelona | 08036 | Spain |
| Inst. Cat. Doncologia-H Duran I Reynals | Active, not recruiting | L'Hospitalet de Llobregat | 08908 | Spain |
| Hosp. Gral. Univ. Gregorio Maranon | Active, not recruiting | Madrid | 28007 | Spain |
| Clinica Univ. de Navarra 1 | Completed | Madrid | 28027 | Spain |
| Hosp. Univ. Ramon Y Cajal | Completed | Madrid | 28034 | Spain |
| Hosp. Univ. 12 de Octubre | Active, not recruiting | Madrid | 28041 | Spain |
| Centro Integral Oncológico Clara Campal | Completed | Madrid | 28050 | Spain |
| Hosp. Gral. Univ. J.M. Morales Meseguer | Completed | Murcia | 30008 | Spain |
| Clinica Univ. de Navarra | Active, not recruiting | Pamplona | 31008 | Spain |
| Hosp. Quiron Madrid Pozuelo | Active, not recruiting | Pozuelo de Alarcón | 28223 | Spain |
| Hosp Clinico Univ de Salamanca | Active, not recruiting | Salamanca | 37007 | Spain |
| Hosp. Univ. de Canarias | Active, not recruiting | San Cristóbal de La Laguna | 38320 | Spain |
| Hosp. Mutua Terrassa | Active, not recruiting | Terrassa | 08221 | Spain |
| Hosp. Univ. Dr. Peset | Completed | Valencia | 46017 | Spain |
| Ege Universitesi Tip Fakultesi | Active, not recruiting | Izmir | 35100 | Turkey (Türkiye) |
| CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC | Active, not recruiting | Cherkasy | 18009 | Ukraine |
| Municipal Non-Commercial Enterprise City Clinical Hospital No 4 of Dnipro City Council | Active, not recruiting | Dnipro | 49102 | Ukraine |
| MNE Regional Oncology Center | Active, not recruiting | Kharkiv | 61070 | Ukraine |
| Vinnytsya Regional Clinical Hospital named after M.I.Pirogov | Active, not recruiting | Vinnitsa | 21018 | Ukraine |
| St James University Hospital | Active, not recruiting | Leeds | LS9 7TF | United Kingdom |
| Leicester Royal Infirmary Haematology | Recruiting | Leicester | LE1 5WW | United Kingdom |
| Royal Marsden Hospital | Active, not recruiting | Surrey | SM2 5PT | United Kingdom |
| New Cross Hospital | Recruiting | Wolverhampton | WV10 0QP | United Kingdom |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C556306 | daratumumab |
| C524865 | carfilzomib |
| D003907 | Dexamethasone |
| D000077269 | Lenalidomide |
| C467566 | pomalidomide |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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