A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (1,598 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-01-03, after 2016-07-07 start.
Reason given by the sponsor: “other”
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 2022-01-03. 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: subject hascellcarcinomacancerprior
Phrases that lowered it: myelomamultipleasthmaefficacyclinical -
Sponsor's past termination rate: 18.3% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 57 (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Sponsor type: industry (lowers 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 with a death: 22.8% (raises risk) · Drug's FDA history
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports before start: 90954 (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 26473 (lowers risk) · Drug's FDA history
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Blinding: none (raises risk) · Design
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Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
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Number of arms: 2 (raises risk) · Design
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Responsible party: sponsor (lowers 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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 8 (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
- 109 (typical: 32)
- Sponsor's past termination rate
- 18.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 57 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 90954 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 26473 (typical: 412.5)
- Drug's FAERS reports marked serious
- 88.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, cardiovascular, immunology, hematology
- Drugs matched to FDA substances
- daratumumab, dexamethasone, durvalumab, 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
- 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
- A Study of Pembrolizumab (MK-3475) in Combination With Standard of Care Treatments in Participants With Multiple Myeloma (MK-3475-023/KEYNOTE-023) NCT02036502 · started 2014 · scored riskier than 28% of active trials terminated
- A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple Myeloma NCT02514668 · started 2015 · scored riskier than 28% of active trials completed
- An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD NCT01985126 · started 2013 · scored riskier than 24% of active trials completed
- A Study of JNJ-63723283, an Anti-programmed Death-1 Monoclonal Antibody, Administered in Combination With Daratumumab, Compared With Daratumumab Alone in Participants With Relapsed or Refractory Multiple Myeloma NCT03357952 · started 2017 · scored riskier than 36% 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.