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NCT05438043Active, not recruitingPhase 3

A Study of Daratumumab

A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
214 (actual)
First submitted
24 Jun 2022
Start date
15 Dec 2022
Primary completion date
31 Jan 2029
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT05438043
EU CT number
2022-500138-27-01
EudraCT number
2021-006494-33

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 214
  • From 15 Dec 2022 to the primary completion date, 31 Jan 2029
  • 88 sites in 17 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (88)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ziekenhuis Aan De Stroom
Coordinator of this site? Confirm its status
AntwerpBelgiumActive, not recruiting
Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
Coordinator of this site? Confirm its status
CampinasBrazilUnknown status
Liga Norte Riograndense Contra o Cancer
Coordinator of this site? Confirm its status
NatalBrazilUnknown status
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
Ministerio da Saude Instituto Nacional do Cancer
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilUnknown status
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilUnknown status
Clinica Medica Sao Germano LTDA
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Real e Benemerita Associacao Portuguesa de Beneficencia
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São PauloBrazilUnknown status
Beijing ChaoYang Hospital
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BeijingChinaUnknown status
Peking Union Medical College Hospital
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BeijingChinaUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
Peking University People's Hospital
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BeijingChinaUnknown status
The First Bethune Hospital of Jilin University
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ChangchunChinaUnknown status
West China Hospital Si Chuan University
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ChengduChinaUnknown status
Fujian Medical University
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FuzhouChinaUnknown status
Guangdong General Hospital
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GuangzhouChinaUnknown status
Nanfang Hospital
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GuangzhouChinaUnknown status
First Affiliated Hospital Medical School of Zhejiang University
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HangzhouChinaUnknown status
First Affiliated Hospital of Zhejiang University
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HangzhouChinaUnknown status
Renji Hospital, Shanghai Jiaotong University School of Medicine
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ShanghaiChinaUnknown status
Ruijin Hospital Shanghai Jiao Tong University
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ShanghaiChinaUnknown status
Shanghai Changzheng Hospital
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ShanghaiChinaUnknown status
The First Affiliated Hospital of Soochow University
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SuzhouChinaUnknown status
Institute of Hematology and Blood Diseases Hospital
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TianjinChinaUnknown status
Tianjin Cancer Hospital
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TianjinChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaActive, not recruiting
Fakultni Nemocnice Plzen
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Plzen 23CzechiaActive, not recruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaActive, not recruiting
Klinikum Chemnitz gGmbH
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ChemnitzGermanyActive, not recruiting
Asklepios Klinik Altona
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HamburgGermanyActive, not recruiting
Region Midtjylland
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Aarhus NDenmarkCompleted
Hospital Universitario Fundación Alcorcón
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AlcorcónSpainActive, not recruiting
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital del Mar
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BarcelonaSpainActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainActive, not recruiting
Complejo Asistencial Universitario de Salamanca
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SalamancaSpainActive, not recruiting
Hospital Universitario de Canarias
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San Cristóbal de La LagunaSpainActive, not recruiting
Fundacio Assistencial De Mutua De Terrassa Fpc
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TerrassaSpainActive, not recruiting
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceActive, not recruiting
Hopital Saint Louis
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ParisFranceActive, not recruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceActive, not recruiting
Centre Hospitalier Régional Universitaire de Tours
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ToursFranceActive, not recruiting
St James University Hospital
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LeedsUnited KingdomUnknown status
Leicester Royal Infirmary - Haematology
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LeicesterUnited KingdomUnknown status
Royal Marsden Hospital
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SurreyUnited KingdomUnknown status
New Cross Hospital
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WolverhamptonUnited KingdomUnknown status
General Hospital of Athens - Alexandra
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AthensGreeceActive, not recruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyCompleted
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyCompleted
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyCompleted
Pusan National University Hospital
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BusanSouth KoreaUnknown status
National Cancer Center
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Goyang-siSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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HwasunSouth KoreaUnknown status
Seoul National University Bundang Hospital
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SeongnamSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
The Catholic University of Korea Seoul St Marys Hospital
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Wojewodzki Szpital Specjalistyczny w Legnicy
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LegnicaPolandCompleted
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandCompleted
S.P. Botkin Moscow City Clinical Hospital
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MoscowRussiaUnknown status
S.P. Botkin Moscow City Clinical Hospital 1
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MoscowRussiaUnknown status
Nizhniy Novgorod Region Clinical Hospital
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Nizhny NovgorodRussiaUnknown status
Republican Hospital named by V.A.Baranova
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PetrozavodskRussiaUnknown status
Ryazan Regional Clinical Hospital
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RyazanRussiaUnknown status
City Hospital No.15
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Saint PetersburgRussiaUnknown status
Clinical Research Institute of Hematology and Transfusiology
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Saint PetersburgRussiaUnknown status
Saratov State Medical University
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SaratovRussiaUnknown status
Oncology Dispensary of Komi Republic
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SyktyvkarRussiaUnknown status
CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC
Coordinator of this site? Confirm its status
CherkasyUkraineUnknown status
Municipal Non-Commercial Enterprise City Clinical Hospital No 4 of Dnipro City Council
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DniproUkraineUnknown status
MNE Regional Oncology Center
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KharkivUkraineUnknown status
Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
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VinnitsaUkraineUnknown status
University Of Michigan Comprehensive Cancer Center
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Ann ArborUnited StatesUnknown status
Emory University
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AtlantaUnited StatesUnknown status
Baylor University Medical Center
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DallasUnited StatesUnknown status
University of Miami - Sylvester Cancer Center
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MiamiUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
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New YorkUnited StatesUnknown status
Barnes-Jewish Hospital
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St LouisUnited StatesUnknown status
Ege Universitesi Tip Fakultesi
Coordinator of this site? Confirm its status
IzmirTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.