Phase II Multicenter, Open-label, Single Arm Clinical Study of Pomalidomide and dexamethasonE and Cyclophosphamide
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 11% 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 (3,728 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2017-08-17, after 2014-04-30 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2017-08-17. 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: heartpatientanginacellpectoris
Phrases that lowered it: subjects wholenalidomidemultiplemyelomadays -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Has a data monitoring committee: Yes (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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Drug's FAERS reports with a death: 27.9% (raises risk) · Drug's FDA history
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Sponsor's past termination rate: 8.7% (raises risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports marked serious: 96.3% (raises risk) · Drug's FDA history
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Responsible party: sponsor (lowers risk) · Design
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Sponsor's past trials: 46 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports before start: 72392 (lowers risk) · Drug's FDA history
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Collaborators: 0 (raises risk) · Design
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
- 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
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 99 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 46 (typical: 32)
- Sponsor's past termination rate
- 8.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 14 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 72392 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 13808 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 27.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, cardiovascular, immunology, hematology
- Drugs matched to FDA substances
- cyclophosphamide, dexamethasone, pomalidomide
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
- Combination Study of Pomalidomide, Marizomib, and Low-Dose Dexamethasone in Relapsed and Refractory Multiple Myeloma NCT02103335 · started 2014 · scored riskier than 32% of active trials completed
- Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal) NCT01575925 · started 2012 · scored riskier than 49% of active trials completed
- Study to Evaluate the Safety and Efficacy of Pomalidomide Monotherapy in Subjects With Refractory or Relapsed Refractory Multiple Myeloma NCT01324947 · started 2011 · scored riskier than 46% of active trials completed
- Study of Pomalidomide, Cyclophosphamide, Dexamethasone in Relapsed/Refractory Multiple Myeloma NCT02176213 · started 2014 · scored riskier than 82% of active trials completed
- Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide NCT01432600 · started 2011 · scored riskier than 99% 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.