Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 5% 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 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 2016-07-14, after 2008-08-21 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 2016-07-14. 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: patienthoursmultiplepatients mustdefined
Phrases that lowered it: efficacyand safetyprostatemyelomamale -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Sponsor's past termination rate: 13.6% (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: 30.2% (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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Trials the sponsor started in the prior 2 years: 26 (lowers risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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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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Maximum age: not given (raises risk) · Who can join
-
Number of arms: 3 (lowers 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: 8285 (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 83.5% (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
- 3 (typical: 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
- 4 (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
- 22 (typical: 32)
- Sponsor's past termination rate
- 13.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 26 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 5 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 41967 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 8285 (typical: 412.5)
- Drug's FAERS reports marked serious
- 83.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 30.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, cardiovascular, immunology, hematology
- Drugs matched to FDA substances
- dexamethasone, lenalidomide, melphalan, prednisone, thalidomide
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
- Cyclophosphamide, Lenalidomide and Dexamethasone (CRD) Versus Melphalan (200 mg/m2) Followed By Autologous Stem Cell Transplant (ASCT) In Newly Diagnosed Multiple Myeloma Subjects NCT01091831 · started 2009 · scored riskier than 33% of active trials completed
- Treatment Optimization in Patients With Untreated Multiple Myeloma NCT02145598 · started 2013 · scored riskier than 18% of active trials terminated
- Lenalidomide and Dexamethasone Versus Melphalan Prednisone and Lenalidomide Versus Cyclophosphamide, Prednisone and Lenalidomide in Elderly Multiple Myeloma Patients NCT01093196 · started 2009 · scored riskier than 28% of active trials completed
- Study of the Efficacy and Safety of RsqVD Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma NCT02219178 · started 2014 · scored riskier than 54% of active trials completed
- Bendamustine in Combination With Lenalidomide and Dexamethasone in Refractory or Relapsed Multiple Myeloma NCT01042704 · started 2008 · scored riskier than 78% 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.