A Study of JNJ-54767414 (Daratumumab) in Combination With Lenalidomide and Dexamethasone in Japanese Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy and Autologous Stem Cell Transplantation
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 3% 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 (1,938 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-03-31, after 2016-09-30 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 2020-03-31. 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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Minimum age: 20 (lowers risk) · Who can join
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 4.2% (lowers risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cellchemotherapysubjectstherapymeasurable
Phrases that lowered it: participantsparticipantjapanesesafety ofevaluate the -
Drug's FAERS reports with a death: 22.4% (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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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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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 13 (lowers risk) · Sponsor's track record
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Number of arms: 1 (raises risk) · Design
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Sponsor's past trials: 71 (lowers 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 (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
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 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
- 71 (typical: 32)
- Sponsor's past termination rate
- 4.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 13 (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
- 184209 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 47023 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, cardiovascular, immunology, hematology
- Drugs matched to FDA substances
- daratumumab, dexamethasone, lenalidomide
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 of JNJ-54767414 (Daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese Participants With Relapsed or Refractory Multiple Myeloma NCT02497378 · started 2015 · scored riskier than 16% of active trials completed
- A Study of Daratumumab in Japanese Participants With Relapsed or Refractory Multiple Myeloma NCT02116569 · started 2014 · scored riskier than 10% of active trials completed
- Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma NCT02252172 · started 2015 · scored riskier than 27% of active trials completed
- A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma NCT02541383 · started 2015 · scored riskier than 51% of active trials completed
- Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan NCT02272803 · started 2015 · scored riskier than 41% 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.