A Study of KRN125 in Patients With Multiple Myeloma and Malignant Lymphoma

Phase 2 Completed 64 enrolled Kyowa Kirin, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

To determine if KRN125 is non-inferior to filgrastim for the mobilization of hematopoietic stem cells into the peripheral blood in patients with multiple myeloma.

Timeline

Start: 2021-09-01
Primary completion: 2022-10-25
Completion: 2022-10-25

Outcome

Met primary endpoint

paper difference: 3.3%; 80% confidence interval: -0.9-7.5%), demonstrating the non-inferiority of pegfilgrastim to filgrastim. PMID 40281003 ↗

Publications

Goto H, Sawa M, Fujiwara SI, Ri M, Ishida T, Takeuchi M, Ishitsuka K, Toyosaki M, Sunami K, Tsukada J, Sonoki T, Shimogomi A, Ichihashi Y, Ouchi Y, Miyamoto T, Hino M, Maeda Y, Teshima T. Impact of single dose of pegfilgrastim on peripheral blood stem cell harvest in patients with multiple myeloma or malignant lymphoma. Sci Rep. 2025 Apr 25;15(1):14523. doi: 10.1038/s41598-025-98453-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	KRN125	Unknown	7.2 mg	Subcutaneous
Comparator	filgrastim	Protein / enzyme biologic	400 ug/m2	Subcutaneous
Background	PLR001	Unknown	0.24 mg/kg	Subcutaneous