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

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.

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