NCT04150692

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Dara-SC	-Subcutaneous daratumumab and hyaluronidase-fihj
PROCEDURE	Blood for research assessments	-Cycle 1 Day 1, Cycle 3 Day 1, and at progression or end of study (whichever is first)
PROCEDURE	Bone marrow for research assessments	-Cycle 1 Day 1, Cycle 3 Day 1, and at progression or end of study (whichever is first)

Timeline

• Start date: 2021-01-08
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2019-11-05
• Last updated: 2022-01-24

Regulatory

• FDA-regulated drug study