JRCT ID: jRCT2011210029
Registered date:06/08/2021
A Study of KRN125 in patients with multiple myeloma and malignant lymphoma
Basic Information
Recruitment status | Complete |
---|---|
Health condition(s) or Problem(s) studied | multiple myeloma and malignant lymphoma |
Date of first enrollment | 07/09/2021 |
Target sample size | 64 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | To investigate the apheresis collection volume of hematopoietic stem cells mobilized into the peripheral blood after a single subcutaneous dose of KRN125 or daily subcutaneous dose of KRN8601. If the criteria are met, the concomitant drug PLR001(plerixafor) is administered subcutaneously12-9 hours before apheresis on the following day. |
Outcome(s)
Primary Outcome | Achievement of a target of >= 2*10^6 CD34+ cells/kg collected during apheresis period in patients with multiple myeloma. |
---|---|
Secondary Outcome | - Achievement of a target of >= 2*10^6 CD34+ cells/kg collected during apheresis period in patients with malignant lymphoma. - Peripheral blood CD34 positive cell count |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
---|---|
Age maximum | <= 75age old |
Gender | Both |
Include 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 |
Exclude 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 |
Related Information
Primary Sponsor | Shimogomi Aiko |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Clinical trial information contact |
Address | 1-9-2, Otemachi , Chiyoda-ku, Tokyo Tokyo Japan 100-0004 |
Telephone | +81-3-5205-7200 |
clinical.info.jp@kyowakirin.com | |
Affiliation | Kyowa Kirin Co., Ltd. |
Scientific contact | |
Name | Aiko Shimogomi |
Address | 1-9-2, Otemachi , Chiyoda-ku, Tokyo Tokyo Japan 100-0004 |
Telephone | +81-3-5205-7200 |
clinical.info.jp@kyowakirin.com | |
Affiliation | Kyowa Kirin Co., Ltd. |