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.
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.
Recruiting
Phase 2
Drug | Synonyms | Arms |
---|---|---|
KRN125(pegfilgrastim), PLR001(plerixafor) | malignant lymphoma cohort | |
KRN8601(filgrastim), PLR001(plerixafor) | multiple myeloma cohort (KRN8601) |
Name | Type | Description | Interventions |
---|---|---|---|
multiple myeloma cohort (KRN125) | Experimental |
| |
multiple myeloma cohort (KRN8601) | Active Comparator |
| |
malignant lymphoma cohort | Experimental |
|
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
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with multiple myeloma. |
Time Frame: | Day 5, 6, 7 |
Safety Issue: | |
Description: |
Measure: | Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with malignant lymphoma. |
Time Frame: | Day 1, 4, 5, 6, 7 |
Safety Issue: | |
Description: |
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Kyowa Kirin Co., Ltd. |
August 16, 2021