Multiple Myeloma and Malignant Lymphoma
Conditions
Brief 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.
Interventions
DRUGKRN125(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.
DRUGKRN8601(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.
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with multiple myeloma. | Day 5, 6, 7 |
Secondary
| Measure | Time frame |
|---|---|
| Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with malignant lymphoma. | Day 1, 4, 5, 6, 7 |
Other
| Measure | Time frame |
|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) | Day 30 or initiation of radiotherapy or chemotherapy |
| Serum KRN125 concentrations | Day 30 or initiation of radiotherapy or chemotherapy |
| Anti-KRN125 antibody | Day 30 or initiation of radiotherapy or chemotherapy |
Countries
Japan
Outcome results
None listed