drugset / Trial / NCT04150692

Escalation of Daratumumab Frequency Following Biochemical Progression in Relapsed/Refractory Multiple Myeloma

NCT04150692

RandomizedParallel-groupOpen-labelTreatment

Summary

In a small case series, the investigators identified five patients who had an initial response to standard daratumumab (weekly for 2 cycles, every other week for 4 cycles, then monthly thereafter) either as mono- or combination therapy, who then had daratumumab frequency escalated when early biochemical progression was noted, an investigational endeavor. In this series, patients received a median of 5 additional cycles of daratumumab at an escalated frequency (range: 2-8). Additionally, the median change in involved paraprotein after one cycle of weekly-escalated dara was -40% (range: -67% to +5%), with most achieving prior partial response or stable disease. In patients who initially have at least a partial response (PR) to daratumumab, who then have biochemical progression following de-escalation, it is conceivable that CD38 saturation is not optimized at the every 4 weeks dosing interval. The investigators believe that escalating the frequency of daratumumab in patients with biochemical progression, in this investigational setting, may recapture the initial response, delay clinical progression, and/or delay treatment changes.

Timeline

Start
2021-01-08
Primary completion
2026-03-31
Completion
2026-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab Monoclonal antibody 1800 mg Subcutaneous
Background rHuPH20 Protein / enzyme biologic 30000 iu Subcutaneous

Indications