Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2022-12-15
2029-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Daratumumab
Daratumumab will be administered either intravenously or subcutaneously.
Carfilzomib
Carfilzomib will be administered intravenously.
Dexamethasone
Dexamethasone will be administered either orally or intravenously.
Lenalidomide
Lenalidomide will be administered orally.
Pomalidomide
Pomalidomide will be administered orally.
Interventions
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Daratumumab
Daratumumab will be administered either intravenously or subcutaneously.
Carfilzomib
Carfilzomib will be administered intravenously.
Dexamethasone
Dexamethasone will be administered either orally or intravenously.
Lenalidomide
Lenalidomide will be administered orally.
Pomalidomide
Pomalidomide will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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University of Miami Sylvester Cancer Center
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barnes-jewish Hospital
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Baylor University Medical Center
Dallas, Texas, United States
ZNA Stuivenberg
Antwerp, , Belgium
Clinica Medica Sao Germano S/S LTDA
São Paulo, , Brazil
Peking Union Medical College Hospital
Beijing, , China
Beijing Chaoyang Hospital
Beijing, , China
Peking University First Hospital
Beijing, , China
Peking University People s Hospital
Beijing, , China
The First Bethune Hospital of Jilin University
Changchun, , China
West China Hospital Si Chuan University
Chengdu, , China
Fujian Medical University
Fuzhou, , China
Guangdong General Hospital
Guangzhou, , China
Nanfang Hospital
Guangzhou, , China
First Affiliated Hospital Medical School of Zhejiang University
Hangzhou, , China
First affiliated Hospital of Zhejiang University
Hangzhou, , China
Shanghai Changzheng Hospital
Shanghai, , China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, , China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
First Affiliated Hospital SooChow University
Suzhou, , China
Tianjin cancer hospital
Tianjin, , China
Institute of Hematology and Blood Diseases Hospital
Tianjin, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
Henan Cancer Hospital
Zhengzhou, , China
Aarhus University Hospital
Aarhus N, , Denmark
Centre Hospitalier Universitaire (CHU) de Caen
Caen, , France
CHU Nantes
Nantes, , France
Hopital Saint Louis
Paris, , France
Hopital Haut Leveque
Pessac, , France
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Asklepios Klinik Altona
Hamburg, , Germany
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
Tübingen, , Germany
Alexandra General Hospital of Athens
Athens Attica, , Greece
Anticancer Hospital of Thessaloniki Theageneio
Thessaloniki, , Greece
Universita Degli Studi di Roma Tor Vergata
Roma, , Italy
Sapienza University of Rome
Roma, , Italy
Wojewodzki Szpital Specjalistyczny w Legnicy
Legnica, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, , Poland
S.P. Botkin Moscow City Clinical Hospital
Moscow, , Russia
Nizhniy Novgorod Region Clinical Hospital
Nizhny Novgorod, , Russia
Republican Hospital named by V.A.Baranova
Petrozavodsk, , Russia
Ryazan Regional Clinical Hospital
Ryazan, , Russia
Clinical Research Institute of Hematology and Transfusiology
Saint Petersburg, , Russia
City Hospital No.15
Saint Petersburg, , Russia
Saratov State Medical University
Saratov, , Russia
Oncology Dispensary of Komi Republic
Syktyvkar, , Russia
Pusan National University Hospital
Busan, , South Korea
National Cancer Center
Goyang-si, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, , South Korea
Hosp. Univ. Fundacion Alcorcon
Alcorcón, , Spain
Hosp. Univ. Germans Trias I Pujol
Badalona, , Spain
Hosp. Del Mar
Barcelona, , Spain
Hosp Clinic de Barcelona
Barcelona, , Spain
Inst. Cat. Doncologia-H Duran I Reynals
L'Hospitalet de Llobregat, , Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, , Spain
Clinica Univ. de Navarra
Madrid, , Spain
Hosp. Univ. Ramon Y Cajal
Madrid, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Centro Integral Oncológico Clara Campal
Madrid, , Spain
Hosp. Gral. Univ. J.M. Morales Meseguer
Murcia, , Spain
Clinica Univ. de Navarra
Pamplona, , Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, , Spain
Hosp Clinico Univ de Salamanca
Salamanca, , Spain
Hosp. Univ. de Canarias
San Cristóbal de La Laguna, , Spain
Hosp. Mutua Terrassa
Terrassa, , Spain
Hosp. Univ. Dr. Peset
Valencia, , Spain
Ege Universitesi Tip Fakultesi
Izmir, , Turkey (Türkiye)
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
Cherkasy, , Ukraine
Municipal Non-Commercial Enterprise City Clinical Hospital No 4 of Dnipro City Council
Dnipro, , Ukraine
Kharkov Regional Clinical Oncology Center, Dept. of Hematology
Kharkiv, , Ukraine
Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
Vinnitsa, , Ukraine
St James University Hospital
Leeds, , United Kingdom
Royal Marsden Hospital
Surrey, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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54767414MMY3030
Identifier Type: OTHER
Identifier Source: secondary_id
2021-006494-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022-500138-27-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109200
Identifier Type: -
Identifier Source: org_study_id