Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Daratumumab in Transplant-Eligible Multiple Myeloma
NCT03477539Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2018
- Primary completion
- May 2022
- Countries
- 1
- Sponsor
- Mayo Clinic
- Modality
- Recombinant Proteins and Enzymes, Monoclonal Antibodies
- Drugs
- daratumumab
- Conditions
- multiple myeloma (MM)
01
Overview
Phase 2, open-label, single-arm trial of daratumumab in multiple myeloma (MM), sponsored by Mayo Clinic. Primary endpoint: Rate of Minimal Residual Disease (MRD) Negative Response After Autologous Stem Cell Transplantation (ASCT) at 100 days. Started Apr 2018; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment (daratumumab, ASCT, lenalidomide)
Daratumumab consolidation, ASCT, and daratumumab + lenalidomide maintenance
03
Who it enrols
Transplant-eligible multiple myeloma patients who have received prior induction therapy, have measurable MRD, adequate organ function, and no prior ASCT or daratumumab therapy.
04
Endpoints
Primary
Rate of Minimal Residual Disease (MRD) Negative Response After Autologous Stem Cell Transplantation (ASCT)
Secondary
The Rate of MRD Negative Response After Pre-stem Cell Transplant (SCT) Consolidation With Daratumumab
Rate of MRD Negative Response After 1 Year (12 Courses) of Daratumumab and Lenalidomide Maintenance
Progression-free Survival
Overall Survival
Overall Response Rate
Incidence of Adverse Events
Beyond the preview
Go deeper on NCT03477539.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT03477539.