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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multiple myeloma cohort (KRN125) | Experimental |
| |
| multiple myeloma cohort (KRN8601) | Active Comparator |
| |
| malignant lymphoma cohort | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KRN125(pegfilgrastim), PLR001(plerixafor) | Drug | 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. |
| 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 |
| 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 |
| Measure | Description | 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 |
Inclusion Criteria:
Criteria for the multiple myeloma cohort
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya City University Hospital | Nagoya | Aichi-ken | Japan | |||
| The Jikei University Kashiwa Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40281003 | Derived | 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. |
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|
| KRN8601(filgrastim), PLR001(plerixafor) | Drug | 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. |
|
| Anti-KRN125 antibody | Day 30 or initiation of radiotherapy or chemotherapy |
| 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 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008206 | Lymphatic Diseases |
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