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NCT04824794 (HexaBody-CD38 in relapsed or refractory multiple myeloma): BVCT ex-ante prediction vs. reported outcome

On 9 Jul 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 10 Mar 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (ORR) and commercially probably sufficient (CR).

Clinical Trial

NCTID
NCT04824794
Drug Name
HexaBody-CD38 (GEN3014)
Drug MoA
anti-CD38 mAb with Fc-domain-specific E430G mutation
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
relapsed or refractory multiple myeloma (RRMM)
Human Patients
130
Sponsor
Genmab / Johnson & Johnson
Phase
Phase 1 Phase 2

Prediction of , index 1673

Prospective Prediction
Prediction Index
1673
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in CR/OS superior to daratumumab for RRMM)
Technical Prediction
SUCCESS (statistically significant clinical benefit in PFS/ORR superior to daratumumab for RRMM)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
244 days in advance
Readout Data Interpretation
GEN3014 achieved 55% ORR and 7% CR; superior to 52% ORR and 2% CR achieved by the daratumumab arm
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (ORR) and commercially probably sufficient (CR)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies
Phase
Phase 1, Phase 2
Status
Terminated
Enrollment
130
Lead sponsor
Genmab
Conditions
Relapsed or Refractory Multiple Myeloma (RRMM); Diffuse Large B Cell Lymphoma (DLBCL); Acute Myeloid Leukemia (AML)
Interventions
BIOLOGICAL: GEN3014; DRUG: Daratumumab
Design
Randomized · Sequential · None
Primary purpose
Treatment
Start
2021-03-09
Primary completion
2025-06-30
Completion
2025-07-31
Results first posted
2026-05-19
Primary outcomes
  • Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs) (28 days during the first cycle (cycle =28 days))
  • Dose Escalation: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Up to approximately 4 years 3 months)
  • Expansion Part A: Objective Response Rate (ORR) (Up to approximately 4 years 3 months)
  • Expansion Part B: ORR (Up to approximately 4 years 3 months)

NCT04824794 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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