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NCT04484623 (belantamab mafodotin in Relapsed/​Refractory Multiple Myeloma): BVCT ex-ante prediction vs. reported outcome

On 15 Aug 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 17 Jul 2025 readout is classified on the dashboard as True Negative (TN). Recorded clinical-benefit conclusion: statistically significant (PFS) and commercially insufficient (FDA disapproval recommendation due to overall insufficient OS benefit given insignificant OS in DREAMM 8 despite significant OS in DREAMM 7).

Clinical Trial

NCTID
NCT04484623
Acronym
DREAMM 8
Drug Name
belantamab mafodotin
Drug MoA
anti-BCMA ADC
Drug Modality
ADC
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Relapsed/​Refractory Multiple Myeloma
Human Patients
302
Sponsor
GlaxoSmithKline
Phase
Phase 3

Prediction of , index 1751

Prospective Prediction
Prediction Index
1751
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in OS non-superior to bortezomib when combined with pomalidomide + dexamethasone)
Technical Prediction
partial SUCCESS (statistically significant additive clinical benefit in PFS superior to bortezomib when combined with pomalidomide + dexamethasone) partial FAILURE (statistically insignificant additive clinical benefit in ORR non-superior to bortezomib)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
336 days in advance
Readout Data Interpretation
belantamab mafodotin + bortezomib + dexamethasone (BVd) achieved 48% reduction in the risk of progression (PFS HR = 0.52 p=0.0001)) and statistically insignificant reduction in the risk of death (OS HR = 0.77 p = 0.1896) compared with daratumumab + bortezomib + dexamethasone (DVd)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (PFS) and commercially insufficient (FDA disapproval recommendation due to overall insufficient OS benefit given insignificant OS in DREAMM 8 despite significant OS in DREAMM 7)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8)
Phase
Phase 3
Status
Active not recruiting
Enrollment
302
Lead sponsor
GlaxoSmithKline
Conditions
Multiple Myeloma
Interventions
DRUG: Belantamab mafodotin; DRUG: Pomalidomide; DRUG: Dexamethasone; DRUG: Bortezomib
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2020-10-01
Primary completion
2024-01-29
Completion
2029-06-25
Results first posted
2025-03-18
Primary outcomes
  • Progression-Free Survival (PFS) (Up to approximately 174 weeks)

NCT04484623 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials