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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Myeloma and Malignant Lymphoma

Intervention / Treatment
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* Drug: KRN125(pegfilgrastim), PLR001(plerixafor)
* Drug: KRN8601(filgrastim), PLR001(plerixafor)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multiple myeloma cohort (KRN125)<br> | Drug: KRN125(pegfilgrastim), PLR001(plerixafor)<br>* 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.<br>|
| Active Comparator: multiple myeloma cohort (KRN8601)<br> | Drug: KRN8601(filgrastim), PLR001(plerixafor)<br>* 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.<br>|
| Experimental: malignant lymphoma cohort<br> | Drug: KRN125(pegfilgrastim), PLR001(plerixafor)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |