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

Kyowa Kirin

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma and Malignant Lymphoma

Treatments

Drug: KRN8601(filgrastim), PLR001(plerixafor)

Drug: KRN125(pegfilgrastim), PLR001(plerixafor)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05007652

125-102

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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