NCT04150692

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

Withdrawn Phase 2 Last updated 24 January 2022

What this trial tests

Phase 2 trial testing Dara-SC in Multiple Myeloma. Withdrawn.

Timeline

8 January 2021

Primary endpoint
31 March 2026

31 March 2026

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	8 January 2021
Primary completion	31 March 2026
Estimated completion	31 March 2026

Drugs / interventions tested

• Dara-SC
• Blood for research assessments
• Bone marrow for research assessments

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Current Adenosinergic Therapies: What Do Cancer Cells Stand to Gain and Lose?
   Kotulová J, Hajdúch M, Džubák P. · · 2021 · cited 11× · PMID 34830449 · DOI 10.3390/ijms222212569