A Study of KRN125 in Patients With Multiple Myeloma and Malignant Lymphoma
NCT ID: NCT05007652
Last Updated: 2023-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2021-09-01
2022-10-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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multiple myeloma cohort (KRN125)
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.
multiple myeloma cohort (KRN8601)
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.
malignant lymphoma cohort
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
75 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
The Jikei University Kashiwa Hospital
Kashiwa, Chiba, Japan
Hospital of the University of Occupational and Environmental Health
Kitakyushu, Fukuoka, Japan
Hokkaido University Hospital of the National University Corporation
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, Japan
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, Japan
Chiba Cancer Center
Chiba, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Kagoshima University Hospital
Kagoshima, , Japan
Kochi Health Sciences Center
Kochi, , Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, , Japan
Niigata University Medical and Dental Hospital
Niigata, , Japan
National Hospital Organization Okayama Medical Center
Okayama, , Japan
Osaka International Cencer Institute
Osaka, , Japan
Wakayama Medical University Hospital
Wakayama, , Japan
Countries
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References
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Goto H, Sawa M, Fujiwara SI, Ri M, Ishida T, Takeuchi M, Ishitsuka K, Toyosaki M, Sunami K, Tsukada J, Sonoki T, Shimogomi A, Ichihashi Y, Ouchi Y, Miyamoto T, Hino M, Maeda Y, Teshima T. Impact of single dose of pegfilgrastim on peripheral blood stem cell harvest in patients with multiple myeloma or malignant lymphoma. Sci Rep. 2025 Apr 25;15(1):14523. doi: 10.1038/s41598-025-98453-7.
Other Identifiers
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125-102
Identifier Type: -
Identifier Source: org_study_id
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