A Study of Daratumumab
A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study
4 other identifiers
interventional
213
17 countries
92
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 multiple-myeloma
Started Dec 2022
Typical duration for phase_3 multiple-myeloma
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2022
CompletedFirst Posted
Study publicly available on registry
June 29, 2022
CompletedStudy Start
First participant enrolled
December 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
July 31, 2026
July 1, 2026
6.1 years
June 24, 2022
July 30, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (1)
Daratumumab
EXPERIMENTALParticipants 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.
Interventions
Daratumumab will be administered either intravenously or subcutaneously.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (92)
University of Miami Sylvester Cancer Center
Miami, Florida, 33136, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Barnes-jewish Hospital
St Louis, Missouri, 63108, United States
Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
ZAS Cadix
Antwerp, 2030, Belgium
UNICAMP
Campinas, 13083-970, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59062 000, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, 90610-000, Brazil
Ministerio da Saude Instituto Nacional do Cancer
Rio de Janeiro, 20230-130, Brazil
COI Clinicas Oncologicas Integradas
Rio de Janeiro, 22793 080, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, 01323 010, Brazil
Clinica Medica Sao Germano S/S LTDA
São Paulo, 04537-081, Brazil
Peking Union Medical College Hospital
Beijing, 100006, China
Beijing Chaoyang Hospital
Beijing, 100020, China
Peking University First Hospital
Beijing, 100034, China
Peking University People's Hospital
Beijing, 100044, China
The First Bethune Hospital of Jilin University
Changchun, 130021, China
West China Hospital Si Chuan University
Chengdu, 610041, China
Fujian Medical University
Fuzhou, 350001, China
Guangdong General Hospital
Guangzhou, 510080, China
Nanfang Hospital
Guangzhou, 510515, China
First Affiliated Hospital Medical School of Zhejiang University
Hangzhou, 310020, China
First affiliated Hospital of Zhejiang University
Hangzhou, 310020, China
Shanghai Changzheng Hospital
Shanghai, 200003, China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, 200025, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200127, China
The First Affiliated Hospital of Soochow University
Suzhou, 215002, China
Tianjin cancer hospital
Tianjin, 300060, China
Institute of Hematology and Blood Diseases Hospital
Tianjin, 300320, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Fakultni nemocnice Brno
Brno, 62500, Czechia
Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni (Main)
Pilsen, 304 60, Czechia
Všeobecná fakultní nemocnice v
Prague, 128 08, Czechia
Aarhus University Hospital
Aarhus N, DK-8200, Denmark
Centre Hospitalier Universitaire (CHU) de Caen
Caen, 14033, France
CHU Nantes
Nantes, 44000, France
Hopital Saint Louis
Paris, 75010, France
Hopital Haut Leveque
Pessac, 33604, France
Klinikum Chemnitz gGmbH
Chemnitz, 09113, Germany
Asklepios Klinik Altona
Hamburg, 22763, Germany
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
Tübingen, 72076, Germany
Alexandra General Hospital of Athens
Athens Attica, 115 28, Greece
Universita Degli Studi di Roma Tor Vergata
Roma, 00133, Italy
Sapienza University of Rome
Roma, 00161, Italy
Wojewodzki Szpital Specjalistyczny w Legnicy
Legnica, 59-220, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-569, Poland
S.P. Botkin Moscow City Clinical Hospital 1
Moscow, 125284, Russia
S.P. Botkin Moscow City Clinical Hospital
Moscow, 125284, Russia
Nizhniy Novgorod Region Clinical Hospital
Nizhny Novgorod, 603126, Russia
Republican Hospital named by V.A.Baranova
Petrozavodsk, 185019, Russia
Ryazan Regional Clinical Hospital
Ryazan, 390003, Russia
Clinical Research Institute of Hematology and Transfusiology
Saint Petersburg, 191024, Russia
City Hospital No.15
Saint Petersburg, 198205, Russia
Saratov State Medical University
Saratov, 410012, Russia
Oncology Dispensary of Komi Republic
Syktyvkar, 167904, Russia
Pusan National University Hospital
Busan, 49241, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Chonnam National University Hwasun Hospital
Hwasun, 519-800, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Hosp. Univ. Fundacion Alcorcon
Alcorcón, 28922, Spain
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916, Spain
Hosp. Del Mar
Barcelona, 08003, Spain
Hosp Clinic de Barcelona
Barcelona, 08036, Spain
Inst. Cat. Doncologia-H Duran I Reynals
L'Hospitalet de Llobregat, 08908, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007, Spain
Clinica Univ. de Navarra 1
Madrid, 28027, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, 28034, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Centro Integral Oncológico Clara Campal
Madrid, 28050, Spain
Hosp. Gral. Univ. J.M. Morales Meseguer
Murcia, 30008, Spain
Clinica Univ. de Navarra
Pamplona, 31008, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, 28223, Spain
Hosp Clinico Univ de Salamanca
Salamanca, 37007, Spain
Hosp. Univ. de Canarias
San Cristóbal de La Laguna, 38320, Spain
Hosp. Mutua Terrassa
Terrassa, 08221, Spain
Hosp. Univ. Dr. Peset
Valencia, 46017, Spain
Ege Universitesi Tip Fakultesi
Izmir, 35100, Turkey (Türkiye)
CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC
Cherkasy, 18009, Ukraine
Municipal Non-Commercial Enterprise City Clinical Hospital No 4 of Dnipro City Council
Dnipro, 49102, Ukraine
MNE Regional Oncology Center
Kharkiv, 61070, Ukraine
Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
Vinnitsa, 21018, Ukraine
St James University Hospital
Leeds, LS9 7TF, United Kingdom
Leicester Royal Infirmary Haematology
Leicester, LE1 5WW, United Kingdom
Royal Marsden Hospital
Surrey, SM2 5PT, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2022
First Posted
June 29, 2022
Study Start
December 15, 2022
Primary Completion (Estimated)
January 31, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
July 31, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
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