Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab

Summary

The purpose of this study is to compare the efficacy (rate of very good partial response \[VGPR\] or better as best response as defined by the International Myeloma Working Group \[IMWG\] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab to evaluate daratumumab retreatment.

Timeline

Start

2019-05-31

Primary completion

2022-10-24

Completion

2023-01-10

Outcome

Missed primary endpoint

Stopped: “The decision was made to discontinue the 54767414MMY2065 study as the Data Review Committee recommendation was early stop of the study for futility.”

paper At the final analysis, 45.5% of D-Kd patients and 40.9% of Kd patients achieved ≥ VGPR (odds ratio, 1.2 [90% CI, 0.59-2.46]; p = 0.6757). PMID 41041907 ↗

Publications

• Bahlis NJ, Zonder J, Karlin L, Plesner T, Paris L, Wrobel T, Hungria V, Besemer B, Crusoe E, Silkjaer T, Perrot A, Moreau P, Wu KL, Delimpasi S, Dimopoulos MA, Levin MD, Mangiacavalli S, Nnane I, Kim YJ, Krevvata M, Sha L, Wroblewski S, Tuozzo A, Carson R, Facon T. Subcutaneous daratumumab plus carfilzomib and dexamethasone (D-Kd) versus carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma who received previous daratumumab treatment: LYNX study. Leuk Lymphoma. 2025 Dec;66(14):2685-2696. doi: 10.1080/10428194.2025.2561117. Epub 2025 Oct 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daratumumab	Monoclonal antibody	1800 mg	Subcutaneous
Background	Carfilzomib	Other / unclassified	20 mg/m2	Intravenous
Background	Carfilzomib	Other / unclassified	70 mg/m2	Intravenous
Background	Dexamethasone	Small molecule	20 mg	Intravenous
Background	Dexamethasone	Small molecule	40 mg	Intravenous

Indications