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NCT05438043 · ClinicalTrials.gov registry record · Phase 3
A Study of Daratumumab
A Phase 3 study of Multiple Myeloma, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT05438043: Recruiting Phase 3 study of Multiple Myeloma, sponsored by Janssen Research & Development.
NCT05438043 is a Phase 3 study of Multiple Myeloma that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 500 participants, roughly in line with the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target. The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05438043, a Phase 3 study of Multiple Myeloma, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Daratumumab
- DRUG Pomalidomide
- DRUG Carfilzomib
Study Locations (20)
Other
- ZAS Cadix - Antwerp
- Liga Norte Riograndense Contra O Cancer - Natal
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS - Porto Alegre
- Ministerio da Saude Instituto Nacional do Cancer - Rio de Janeiro
- COI Clinicas Oncologicas Integradas - Rio de Janeiro
- Real e Benemerita Associacao Portuguesa de Beneficencia - São Paulo
- Clinica Medica Sao Germano S/S LTDA - São Paulo
- Peking Union Medical College Hospital - Beijing
- Beijing Chaoyang Hospital - Beijing
- Peking University First Hospital - Beijing
- Peking University People's Hospital - Beijing
- The First Bethune Hospital of Jilin University - Changchun
- West China Hospital Si Chuan University - Chengdu
New York
- Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg - New York
- Memorial Sloan Kettering Cancer Center - New York
Florida
- University of Miami Sylvester Cancer Center - Miami
Georgia
- Emory University - Atlanta
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Missouri
- Barnes-jewish Hospital - St Louis
Texas
- Baylor University Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2022-12-15 |
| Est. Completion | 2029-01-31 |
| Phase | Phase 3 |
What NCT05438043 shows while recruiting
NCT05438043 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target.
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Dexamethasone is the first listed.
NCT05438043 names 20 study sites across 7 states, led by Other, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT05438043 about?
NCT05438043 is a clinical study titled "A Study of Daratumumab". 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 fo...
What is the current status of trial NCT05438043?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2022-12-15. Estimated completion is 2029-01-31.
What conditions does trial NCT05438043 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT05438043?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Daratumumab (DRUG), Pomalidomide (DRUG), Carfilzomib (DRUG).
Who is sponsoring clinical trial NCT05438043?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05438043 being conducted?
This trial has 20 study locations across Florida, Georgia, Michigan, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05438043's enrollment target sits among peer trials
500 42nd of 438 higher than 392 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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