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Active, not recruiting Phase 3

A Study of Daratumumab

NCT05438043 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2022-12-15
Last updated
2026-09-25

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Daratumumab →Carfilzomib →Dexamethasone →Lenalidomide →Pomalidomide →

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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

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)

FacilityCityRegionStatus
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.

Official registry record

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 Italy