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NCT05363111 · ClinicalTrials.gov registry record · Phase 1
Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma
A Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05363111: Recruiting Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, sponsored by City of Hope Medical Center.
NCT05363111 is a Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 15 participants, below the 46-participant average among 25 other Refractory Plasma Cell Myeloma trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05363111, a Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety, side effects, and best dose of actinium Ac 225-DOTA-daratumumab (225Ac-DOTA-daratumumab) in combination with daratumumab and indium In 111-DOTA-daratumumab (111In-DOTA-daratumumab) in treating patients with multiple myeloma that does not respond to treatment (refractory) or that has come back (recurrent). Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. 111In-DOTA-daratumumab and 225Ac-DOTA-daratumumab are forms of radioimmunotherapy in which a monoclonal antibody, daratumumab, has been linked to a radiotracer to allow for targeted delivery of the treatment to cancer cells. Giving all three together may kill more cancer cells.
Primary Outcome
Toxicity will be graded according to the National Cancer Institute (NCI)- Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Conditions Studied
Interventions
- BIOLOGICAL Daratumumab
- BIOLOGICAL Actinium Ac 225-DOTA-Daratumumab
- BIOLOGICAL Indium In 111-DOTA-Daratumumab
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-11-22 |
| Est. Completion | 2027-03-23 |
| Phase | Phase 1 |
What NCT05363111 shows while recruiting
NCT05363111 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 46-participant average among 25 other Refractory Plasma Cell Myeloma trials with a reported enrollment target (67% lower).
The record links to 2 conditions, with Refractory Plasma Cell Myeloma appearing as the primary indexed condition, and to 3 interventions - of which Daratumumab is the first listed.
NCT05363111 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05363111 about?
NCT05363111 is a clinical study titled "Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma". This phase I trial tests the safety, side effects, and best dose of actinium Ac 225-DOTA-daratumumab (225Ac-DOTA-daratumumab) in combination with daratumumab and indium In 111-DOTA-daratumumab (111In-DOTA-daratumumab) in treating patients with multiple myeloma that does not respond to treatment (ref...
What is the current status of trial NCT05363111?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2022-11-22. Estimated completion is 2027-03-23.
What conditions does trial NCT05363111 study?
This clinical trial studies the following conditions: Refractory Plasma Cell Myeloma, Recurrent Plasma Cell Myeloma.
What interventions are being tested in trial NCT05363111?
The interventions under investigation include: Daratumumab (BIOLOGICAL), Actinium Ac 225-DOTA-Daratumumab (BIOLOGICAL), Indium In 111-DOTA-Daratumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05363111?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05363111 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Refractory Plasma Cell 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 NCT05363111's enrollment target sits among peer trials
15 19th of 25 higher than 6 of 25 other Refractory Plasma Cell Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Plasma Cell 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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