NCT05007652

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

A Clinical Trial of KRN125 to Mobilize Hematopoietic Stem Cells Into Peripheral Blood in Patients With Multiple Myeloma and Malignant Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma and Malignant Lymphoma

Interventions

Type	Name	Description
DRUG	KRN125(pegfilgrastim), PLR001(plerixafor)	7.2 mg of KRN125 in Day 1 Single subcutaneous administration The concomitant drug PLR001 is administered subcutaneously once daily at a dose of 0.24 mg/kg when meets the criteria. The dosing period is 12-9 hours before apheresis on the following day.
DRUG	KRN8601(filgrastim), PLR001(plerixafor)	400 ug/m2 of KRN8601 from Day 1 to the end date of the Apheresis Once daily subcutaneous administration The concomitant drug PLR001 is administered subcutaneously once daily at a dose of 0.24 mg/kg when meets the criteria. The dosing period is 12-9 hours before apheresis on the following day.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-10-25
• Completion: 2022-10-25
• First posted: 2021-08-16
• Last updated: 2023-02-21

Locations

21 sites across 1 country: Japan