Daratumumab for the Treatment of Patients With AL Amyloidosis
Model scores of the 29,894 trials active now.
Model score 30% for any early termination, 22% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (851 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-07-17, after 2017-03-20 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2020-07-17. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cancerpatientstagecelltransplant
Phrases that lowered it: participantsiiibasthmaefficacyplasma -
Sponsor's past termination rate: 14.6% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1/2 (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Design: single group (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports marked serious: 76.3% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 14.3% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 30 (lowers risk) · Sponsor's track record
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Number of arms: 1 (raises risk) · Design
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Blinding: none (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Collaborators: 1 (raises risk) · Design
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Drug's FAERS reports before start: 1794 (raises risk) · Drug's FDA history
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Sponsor's past trials: 96 (raises risk) · Sponsor's track record
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1/2 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 96 (typical: 32)
- Sponsor's past termination rate
- 14.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 30 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 1794 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1479 (typical: 412.5)
- Drug's FAERS reports marked serious
- 76.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, metabolic, immunology
- Drugs matched to FDA substances
- daratumumab
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Daratumumab Therapy for Patients With Refractory or Relapsed AL Amyloidosis NCT02816476 · started 2016 · scored riskier than 82% of active trials completed
- Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis NCT04895917 · started 2021 · scored riskier than 77% of active trials terminated
- A Study of Daratumumab Monotherapy in Previously Untreated Patients With Stage 3B Light Chain (AL) Amyloidosis NCT04131309 · started 2019 · scored riskier than 87% of active trials completed
- Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis NCT01222260 · started 2013 · scored riskier than 99% of active trials completed
- A Safety Study of Carfilzomib in Patients With Previously-Treated Systemic Light Chain Amyloidosis NCT01789242 · started 2013 · scored riskier than 53% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.