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Clinical trial

A Clinical Trial of KRN125 to Mobilize Hematopoietic Stem Cells Into Peripheral Blood in Patients With Multiple Myeloma and Malignant Lymphoma

ID
Name
125-102
Description
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.
Trial arms
Trial start
2021-09-01
Estimated PCD
2022-10-25
Trial end
2022-10-25
Status
Completed
Phase
Early phase I
Treatment
KRN125(pegfilgrastim), PLR001(plerixafor)
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.
Arms:
malignant lymphoma cohort, multiple myeloma cohort (KRN125)
KRN8601(filgrastim), PLR001(plerixafor)
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.
Arms:
multiple myeloma cohort (KRN8601)
Size
64
Primary endpoint
Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with multiple myeloma.
Day 5, 6, 7
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 64, 'type': 'ACTUAL'}}
Updated at
2023-02-21

1 organization

2 products

1 indication

Product
KRN125
Indication
Multiple Myeloma and Malignant Lymphoma
Product
KRN8601
Organization
Kyowa Kirin