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NCT05560399 · ClinicalTrials.gov registry record · Early Phase 1
A Study of Iberdomide (CC-220) in Combination With Elotuzumab and Dexamethasone for Relapsed/Refractory Multiple Myeloma
A Early Phase 1 study of Multiple Myeloma, sponsored by Icahn School of Medicine at Mount Sinai.
- Active
- Registry status
- Early Phase 1
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT05560399: Active Early Phase 1 study of Multiple Myeloma, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05560399 is a Early Phase 1 study of Multiple Myeloma that is active but no longer recruiting, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 7 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05560399, a Early Phase 1 study of Multiple Myeloma, is active but no longer recruiting, sponsored by Icahn School of Medicine at Mount Sinai.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-arm, open-label study evaluating the safety, tolerability and efficacy of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone in patients with RRMM. The researchers hypothesize that the combination of Iberdomide and Elotuzumab will synergize to promote myeloma cell death, resulting in an overall response rate of at least 53%, with an acceptable safety profile. Patients will be enrolled in a 3+3 dose escalation cohort to evaluate the safety of this combination and to establish the MTD (maximum tolerated dose). The MTD will be the dose for the patients enrolled in dose expansion cohort. A total maximum of 37 patients will be recruited: maximum 18 patients will be recruited in the dose escalation phase, followed by an additional 19 patients in the dose expansion cohort for a total of 25 patients treated at the MTD.
Primary Outcome
The dose limiting toxicity (DLT) rate at the Maximum Tolerated Dose, defined as the proportion of patients in the safety population of the study that experience at least 1 DLT within the first cycle of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone treated at the maximum tolerated dose (MTD).
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Iberdomide
- DRUG Elotuzumab
Study Locations (1)
New York
- Icahn School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2023-02-06 |
| Est. Completion | 2026-12 |
| Phase | Early Phase 1 |
What the registry record for NCT05560399 still lists
NCT05560399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 3 interventions - of which Dexamethasone is the first listed.
NCT05560399 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05560399 about?
NCT05560399 is a clinical study titled "A Study of Iberdomide (CC-220) in Combination With Elotuzumab and Dexamethasone for Relapsed/Refractory Multiple Myeloma". This is a single-arm, open-label study evaluating the safety, tolerability and efficacy of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone in patients with RRMM. The researchers hypothesize that the combination of Iberdomide and Elotuzumab will synergize to promote myeloma cell ...
What is the current status of trial NCT05560399?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 7 participants. The study started on 2023-02-06. Estimated completion is 2026-12.
What conditions does trial NCT05560399 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT05560399?
The interventions under investigation include: Dexamethasone (DRUG), Iberdomide (DRUG), Elotuzumab (DRUG).
Who is sponsoring clinical trial NCT05560399?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05560399 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05560399's enrollment target sits among peer trials
7 430th of 438 higher than 6 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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