Back to resultsA Study of KRN125 in Patients With Multiple Myeloma and Malignant Lymphoma
Primary Purpose
Multiple Myeloma and Malignant Lymphoma
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KRN125(pegfilgrastim), PLR001(plerixafor)
KRN8601(filgrastim), PLR001(plerixafor)
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma and Malignant Lymphoma
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
Sites / Locations
- Nagoya City University Hospital
- The Jikei University Kashiwa Hospital
- Hospital of the University of Occupational and Environmental Health
- Hokkaido University Hospital of the National University Corporation
- Kobe City Medical Center General Hospital
- Ishikawa Prefectural Central Hospital
- Tokai University Hospital
- Kanagawa Cancer Center
- Jichi Medical University Hospital
- Juntendo University Hospital
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
- Japanese Red Cross Medical Center
- Chiba Cancer Center
- Kyushu University Hospital
- Kagoshima University Hospital
- Kochi Health Sciences Center
- National Hospital Organization Kumamoto Medical Center
- Niigata University Medical and Dental Hospital
- National Hospital Organization Okayama Medical Center
- Osaka International Cencer Institute
- Wakayama Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
multiple myeloma cohort (KRN125)
multiple myeloma cohort (KRN8601)
malignant lymphoma cohort
Arm Description
Outcomes
Primary Outcome Measures
Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with multiple myeloma.
Secondary Outcome Measures
Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with malignant lymphoma.
Full Information
NCT ID
NCT05007652
First Posted
August 2, 2021
Last Updated
February 19, 2023
Sponsor
Kyowa Kirin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05007652
Brief Title
A Study of KRN125 in Patients With Multiple Myeloma and Malignant Lymphoma
Official Title
A Clinical Trial of KRN125 to Mobilize Hematopoietic Stem Cells Into Peripheral Blood in Patients With Multiple Myeloma and Malignant Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
October 25, 2022 (Actual)
Study Completion Date
October 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Malignant Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
multiple myeloma cohort (KRN125)
Arm Type
Experimental
Arm Title
multiple myeloma cohort (KRN8601)
Arm Type
Active Comparator
Arm Title
malignant lymphoma cohort
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KRN125(pegfilgrastim), PLR001(plerixafor)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
KRN8601(filgrastim), PLR001(plerixafor)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame
Day 30 or initiation of radiotherapy or chemotherapy
Title
Serum KRN125 concentrations
Time Frame
Day 30 or initiation of radiotherapy or chemotherapy
Title
Anti-KRN125 antibody
Time Frame
Day 30 or initiation of radiotherapy or chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
The Jikei University Kashiwa Hospital
City
Kashiwa
State/Province
Chiba
Country
Japan
Facility Name
Hospital of the University of Occupational and Environmental Health
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
Hokkaido University Hospital of the National University Corporation
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Ishikawa Prefectural Central Hospital
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke
State/Province
Tochigi
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Japanese Red Cross Medical Center
City
Shibuya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Chiba Cancer Center
City
Chiba
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
Country
Japan
Facility Name
Kagoshima University Hospital
City
Kagoshima
Country
Japan
Facility Name
Kochi Health Sciences Center
City
Kochi
Country
Japan
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Kumamoto
Country
Japan
Facility Name
Niigata University Medical and Dental Hospital
City
Niigata
Country
Japan
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama
Country
Japan
Facility Name
Osaka International Cencer Institute
City
Osaka
Country
Japan
Facility Name
Wakayama Medical University Hospital
City
Wakayama
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of KRN125 in Patients With Multiple Myeloma and Malignant Lymphoma
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