A Study of Daratumumab
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Number of Participants with Serious Adverse Events (SAEs) — 3 years 7 months
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. - Number of Participants with AEs of Special Interest (AESI) — 3 years 7 months
Number of participants with AESI, that is, reactivation of HBV infection, will be reported. - Number of Participants with Pregnancies or Partner Pregnancies — 3 years 7 months
Number of participants with pregnancies or partner pregnancies will be reported using the appropriate pregnancy notification form. - Number of Participants with Abnormal Pregnancies as SAE — 3 years 7 months
Number of Participants with Abnormal Pregnancies as SAE will be reported.
Trial sites (92)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Miami Sylvester Cancer Center | Miami | Florida | |
| Emory University | Atlanta | Georgia | |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | |
| Barnes-jewish Hospital | St Louis | Missouri | |
| Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg | New York | New York | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| Baylor University Medical Center | Dallas | Texas | |
| ZAS Cadix | Antwerp | Belgium | |
| Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP | Campinas | Brazil | |
| Liga Norte Riograndense Contra O Cancer | Natal | Brazil | |
| Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS | Porto Alegre | Brazil | |
| Ministerio da Saude Instituto Nacional do Cancer | Rio de Janeiro | Brazil | |
| Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI) | Rio de Janeiro | Brazil | |
| Real e Benemerita Associacao Portuguesa de Beneficencia | São Paulo | Brazil | |
| Clinica Medica Sao Germano 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 | |
| The First Affiliated Hospital of 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 | |
| Fakultni nemocnice Brno | Brno | Czechia | |
| Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni (Main) | Pilsen | Czechia | |
| Všeobecná fakultní nemocnice v | Prague | Czechia | |
| Aarhus University Hospital | Aarhus N | Denmark | |
| Centre Hospitalier Universitaire (CHU) de Caen | Caen | France | |
| CHU Nantes | Nantes | France |
+ 52 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05438043 on ClinicalTrials.gov ↗ ← All trials in South Korea