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NCT03283917 · ClinicalTrials.gov registry record · Phase 1
Daratumumab, Ixazomib, and Dexamethasone in AL Amyloidosis
A Phase 1 study of Newly Diagnosed Primary Amyloidosis and Recurrent Primary Amyloidosis, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT03283917: Active Phase 1 study of Newly Diagnosed Primary Amyloidosis and Recurrent Primary Amyloidosis, sponsored by M.D. Anderson Cancer Center.
NCT03283917 is a Phase 1 study of Newly Diagnosed Primary Amyloidosis and Recurrent Primary Amyloidosis that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03283917, a Phase 1 study of Newly Diagnosed Primary Amyloidosis and Recurrent Primary Amyloidosis, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of daratumumab, ixazomib, and dexamethasone in treating participants with amyloid light chain amyloidosis. Monoclonal antibodies, such as daratumumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as ixazomib and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving daratumumab, ixazomib, and dexamethasone may be effective in treating participants with light chain amyloidosis.
Primary Outcome
Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.
Conditions Studied
Interventions
- DRUG Dexamethasone
- BIOLOGICAL Daratumumab
- DRUG Ixazomib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-02-07 |
| Est. Completion | 2027-05-18 |
| Phase | Phase 1 |
What the registry record for NCT03283917 still lists
NCT03283917 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 3 conditions, with Newly Diagnosed Primary Amyloidosis appearing as the primary indexed condition, and to 3 interventions - of which Dexamethasone is the first listed.
NCT03283917 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03283917 about?
NCT03283917 is a clinical study titled "Daratumumab, Ixazomib, and Dexamethasone in AL Amyloidosis". This phase I trial studies the side effects and best dose of daratumumab, ixazomib, and dexamethasone in treating participants with amyloid light chain amyloidosis. Monoclonal antibodies, such as daratumumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherap...
What is the current status of trial NCT03283917?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2018-02-07. Estimated completion is 2027-05-18.
What conditions does trial NCT03283917 study?
This clinical trial studies the following conditions: Newly Diagnosed Primary Amyloidosis, Recurrent Primary Amyloidosis, Refractory Primary Amyloidosis.
What interventions are being tested in trial NCT03283917?
The interventions under investigation include: Dexamethasone (DRUG), Daratumumab (BIOLOGICAL), Ixazomib (DRUG).
Who is sponsoring clinical trial NCT03283917?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03283917 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03283917's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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