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

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Kirin Co., Ltd.
• Treatments: Plerixafor; Plerixafor octahydrochloride

Criteria

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