A Study of Subcutaneous Delivery of JNJ-54767414 in Chinese Participants With Multiple Myeloma

NCT04121260 on ClinicalTrials.gov Phase 1 Janssen Research & Development, LLC (industry) Started 2019-12-25 Completed

Riskier than 14% of active trials

Model scores of the 29,894 trials active now.

Model score 9% 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 (1,938 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2023-10-13, after 2019-12-25 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 2023-10-13. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: therapypriorradiationpurpose ofthe purpose
Phrases that lowered it: participantparticipantsmyelomainvestigatorevaluate the
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 106 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 15.9% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Sponsor's past termination rate: 9.4% (raises risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Design: single group (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Minimum age: 18 (raises risk) · Who can join
Sponsor's past trials: 415 (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports marked serious: 81.5% (lowers risk) · Drug's FDA history
Disease area, cardiovascular: Yes (raises risk) · Disease area

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: 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: 415 (typical: 32)
Sponsor's past termination rate: 9.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 106 (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: 9381 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 3354 (typical: 412.5)
Drug's FAERS reports marked serious: 81.5% (typical: 85.6%)
Drug's FAERS reports with a death: 15.9%

Disease area and drugs

Disease areas: cancer, cardiovascular, immunology, hematology
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

Dose Escalation Study of JNJ-54767414 (Daratumumab) in Chinese Participants With Relapsed or Refractory Multiple Myeloma Who Failed at Least 2 Prior Lines of Systemic Therapy NCT02852837 · started 2016 · scored riskier than 15% 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
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 With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma NCT02519452 · started 2015 · scored riskier than 18% of active trials completed
A Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Japanese Participants With Relapsed or Refractory Multiple Myeloma NCT03242889 · started 2017 · scored riskier than 16% 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.