Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK-3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (MK-3475-183/KEYNOTE-183)
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (927 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2020-07-16, after 2015-10-19 start.
Reason given by the sponsor: “business”
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 2020-07-16. 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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Sponsor's past termination rate: 17.2% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: breastcancerprioreligibledisease
Phrases that lowered it: participantsmyelomadexamethasoneparticipantthe efficacy -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 115 (lowers risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Sponsor's past trials: 1112 (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 24.3% (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Drug's FAERS reports in the prior 12 months: 26115 (lowers risk) · Drug's FDA history
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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 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
- industry (typical: academic or other)
- Sponsor's past trials
- 1112 (typical: 32)
- Sponsor's past termination rate
- 17.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 115 (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
- 71999 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 26115 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 24.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, cardiovascular, immunology, hematology
- Drugs matched to FDA substances
- dexamethasone, pembrolizumab, 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
- Study of Lenalidomide and Dexamethasone With or Without Pembrolizumab (MK-3475) in Participants With Newly Diagnosed Treatment Naive Multiple Myeloma (MK-3475-185/KEYNOTE-185) NCT02579863 · started 2015 · scored riskier than 35% of active trials terminated
- A Study to Determine Dose and Regimen of Durvalumab as Monotherapy or in Combination With Pomalidomide With or Without Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma NCT02616640 · started 2016 · scored riskier than 70% of active trials completed
- Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma NCT01712789 · started 2012 · scored riskier than 38% of active trials completed
- A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study NCT01311687 · started 2011 · scored riskier than 47% of active trials completed
- The Safety and Efficacy of Pomalidomide in Combination With Cyclophosphamide and Dexamethasone (PCD) in the Transplant-ineligible Patients With Relapsed and/or Refractory Multiple Myeloma (MM) NCT03242460 · started 2015 · scored riskier than 64% 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.