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

Kyowa Kirin Co., Ltd.64 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma and Malignant Lymphoma

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: Criteria for the multiple myeloma cohort * Patients with histologically or pathologically diagnosed multiple myeloma * Patients who achieved CR, sCR, VGPR, and PR with induction therapy Criteria for the malignant lymphoma cohort * Patients with histologically or pathologically diagnosed malignant lymphoma * First or second CR or PR Multiple myeloma cohort, malignant lymphoma cohort common criteria * Patients aged 20 to 75 years or younger at the time of informed consent Exclusion Criteria: * Those who received allogeneic hematopoietic stem cell transplantation (Allo-SCT), autologous hematopoietic stem cell transplantation (ASCT), or CAR-T therapy * Patients who have developed adverse events leading to discontinuation of hematopoietic stem-cell collection due to administration of granulocyte colony-stimulating factor (G-CSF) or apheresis * Patients who have not been able to collect adequate amounts of hematopoietic stem cells with G-CSF or plerixafor administration * Patients with hypersensitivity to G-CSF or plerixafor * Patients with ECOG Performance status (PSs) of 2 or greater. * Patients whose cardiac or pulmonary conditions were judged to be inappropriate for apheresis or ASCT. * Pregnant or breastfeeding female patients

Locations (21)

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

The Jikei University Kashiwa Hospital

Kashiwa, Chiba, Japan

Outcomes

Primary Outcomes

Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with multiple myeloma.

Time frame: Day 5, 6, 7

Secondary Outcomes

Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with malignant lymphoma.

Time frame: Day 1, 4, 5, 6, 7

Data from ClinicalTrials.gov

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