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NCT05083169 · ClinicalTrials.gov registry record · Phase 3
A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 3 study of Multiple Myeloma, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 587
- Enrollment target
- 20
- Study locations
NCT05083169: Active Phase 3 study of Multiple Myeloma, sponsored by Janssen Research & Development.
NCT05083169 is a Phase 3 study of Multiple Myeloma that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 587 participants, roughly in line with the 545-participant average among 438 other Multiple Myeloma trials with a reported enrollment target. The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05083169, a Phase 3 study of Multiple Myeloma, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 587 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).
Primary Outcome
PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first.
Conditions Studied
Interventions
- DRUG Teclistamab
- DRUG Dexamethasone
- DRUG Daratumumab
- DRUG Pomalidomide
- DRUG Bortezomib
Study Locations (20)
California
- City of Hope - Duarte
- Stanford University Medical Center - Stanford
Michigan
- Henry Ford Hospital - Detroit
- Henry Ford Health System - Southfield
Pennsylvania
- West Penn Hospital - Pittsburgh
- University of Pittsburgh Medical Center - Pittsburgh
Tennessee
- Baptist Cancer Center - Memphis
- Vanderbilt Ingram Cancer Center - Nashville
Other
- Hospital Aleman - Buenos Aires
- Hospital Italiano de Buenos Aires - Buenos Aires
Alabama
- University of Alabama Birmingham - Birmingham
Connecticut
- Yale University - New Haven
Georgia
- Emory University Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 587 participants |
| Start Date | 2021-10-14 |
| Est. Completion | 2028-12-08 |
| Phase | Phase 3 |
What the registry record for NCT05083169 still lists
NCT05083169 is an interventional study that assigns participants to a tested intervention. The registered 587 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 545-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 Teclistamab is the first listed.
NCT05083169 names 20 study sites across 15 states, led by California, Michigan, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05083169 about?
NCT05083169 is a clinical study titled "A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma". The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).
What is the current status of trial NCT05083169?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 587 participants. The study started on 2021-10-14. Estimated completion is 2028-12-08.
What conditions does trial NCT05083169 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT05083169?
The interventions under investigation include: Teclistamab (DRUG), Dexamethasone (DRUG), Daratumumab (DRUG), Pomalidomide (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT05083169?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05083169 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Georgia, Massachusetts. 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 NCT05083169's enrollment target sits among peer trials
587 39th of 438 higher than 400 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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