CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
KRN125(pegfilgrastim), PLR001(plerixafor) +1 moredrug
Likely dose
KRN125(pegfilgrastim), PLR001(plerixafor) 7.2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05007652
NCT05007652Phase 2Completed
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A Clinical Trial of KRN125 to Mobilize Hematopoietic Stem Cells Into Peripheral Blood in Patients With Multiple Myeloma and Malignant Lymphoma

Kyowa Kirin Co., Ltd.·interventional·Posted Aug 16, 2021·Updated Feb 21, 2023

In Brief

A Phase 2 clinical trial evaluating KRN125(pegfilgrastim), PLR001(plerixafor) and KRN8601(filgrastim), PLR001(plerixafor) for Multiple Myeloma and Malignant Lymphoma. Completed, enrolled 64 participants across 21 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma and Malignant Lymphoma
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedAug 16, 2021
Enrollment StartSep 1, 2021
Primary CompletionOct 25, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.9 years ago

Interventions

KRN125(pegfilgrastim), PLR001(plerixafor)drug

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.

KRN8601(filgrastim), PLR001(plerixafor)drug

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.