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
- Diseases
- Multiple myeloma, Childhood cancers
- 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
Sites (88)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ziekenhuis Aan De Stroom Coordinator of this site? Confirm its status | Antwerp | Belgium | Active, not recruiting |
| Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| Liga Norte Riograndense Contra o Cancer Coordinator of this site? Confirm its status | Natal | Brazil | Unknown status |
| Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Ministerio da Saude Instituto Nacional do Cancer Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI) Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Clinica Medica Sao Germano LTDA Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Real e Benemerita Associacao Portuguesa de Beneficencia Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Beijing ChaoYang Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Bethune Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| West China Hospital Si Chuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Guangdong General Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Nanfang Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| First Affiliated Hospital Medical School of Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| First Affiliated Hospital of Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Renji Hospital, Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Ruijin Hospital Shanghai Jiao Tong University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Changzheng Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Institute of Hematology and Blood Diseases Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tianjin Cancer Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Active, not recruiting |
| Fakultni Nemocnice Plzen Coordinator of this site? Confirm its status | Plzen 23 | Czechia | Active, not recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Klinikum Chemnitz gGmbH Coordinator of this site? Confirm its status | Chemnitz | Germany | Active, not recruiting |
| Asklepios Klinik Altona Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Completed |
| Hospital Universitario Fundación Alcorcón Coordinator of this site? Confirm its status | Alcorcón | Spain | Active, not recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Active, not recruiting |
| Complejo Asistencial Universitario de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Active, not recruiting |
| Hospital Universitario de Canarias Coordinator of this site? Confirm its status | San Cristóbal de La Laguna | Spain | Active, not recruiting |
| Fundacio Assistencial De Mutua De Terrassa Fpc Coordinator of this site? Confirm its status | Terrassa | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Active, not recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Active, not recruiting |
| Centre Hospitalier Régional Universitaire de Tours Coordinator of this site? Confirm its status | Tours | France | Active, not recruiting |
| St James University Hospital Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Leicester Royal Infirmary - Haematology Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Royal Marsden Hospital Coordinator of this site? Confirm its status | Surrey | United Kingdom | Unknown status |
| New Cross Hospital Coordinator of this site? Confirm its status | Wolverhampton | United Kingdom | Unknown status |
| General Hospital of Athens - Alexandra Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Completed |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea Seoul St Marys Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Wojewodzki Szpital Specjalistyczny w Legnicy Coordinator of this site? Confirm its status | Legnica | Poland | Completed |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| S.P. Botkin Moscow City Clinical Hospital Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| S.P. Botkin Moscow City Clinical Hospital 1 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Nizhniy Novgorod Region Clinical Hospital Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Unknown status |
| Republican Hospital named by V.A.Baranova Coordinator of this site? Confirm its status | Petrozavodsk | Russia | Unknown status |
| Ryazan Regional Clinical Hospital Coordinator of this site? Confirm its status | Ryazan | Russia | Unknown status |
| City Hospital No.15 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Clinical Research Institute of Hematology and Transfusiology Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Saratov State Medical University Coordinator of this site? Confirm its status | Saratov | Russia | Unknown status |
| Oncology Dispensary of Komi Republic Coordinator of this site? Confirm its status | Syktyvkar | Russia | Unknown status |
| CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC Coordinator of this site? Confirm its status | Cherkasy | Ukraine | Unknown status |
| Municipal Non-Commercial Enterprise City Clinical Hospital No 4 of Dnipro City Council Coordinator of this site? Confirm its status | Dnipro | Ukraine | Unknown status |
| MNE Regional Oncology Center Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Unknown status |
| Vinnytsya Regional Clinical Hospital named after M.I.Pirogov Coordinator of this site? Confirm its status | Vinnitsa | Ukraine | Unknown status |
| University Of Michigan Comprehensive Cancer Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Baylor University Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| University of Miami - Sylvester Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Barnes-Jewish Hospital Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Ege Universitesi Tip Fakultesi Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.