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

Multiple Myeloma Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

• NCT number: NCT04150692
• Study type: Interventional
• Source: Washington University School of Medicine
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 8, 2021
• Completion date: March 31, 2026