臨床研究等提出・公開システム

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

A Study of KRN125 in patients with multiple myeloma and malignant lymphoma

Shimogomi Aiko

Kyowa Kirin Co., Ltd.

1-9-2, Otemachi , Chiyoda-ku, Tokyo

clinical.info.jp@kyowakirin.com

Clinical trial information contact

Kyowa Kirin Co., Ltd.

1-9-2, Otemachi , Chiyoda-ku, Tokyo

+81-3-5205-7200

clinical.info.jp@kyowakirin.com

Complete

Aug. 10, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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

- 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

Both

multiple myeloma and malignant lymphoma

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.

Achievement of a target of >= 2*10^6 CD34+ cells/kg collected during apheresis period in patients with multiple myeloma.

- 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

+81-11-716-1161

No

none