NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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) studiedmultiple myeloma and malignant lymphoma
Date of first enrollment07/09/2021
Target sample size64
Countries of recruitment
Study typeInterventional
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 OutcomeAchievement 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
GenderBoth
Include criteriaCriteria 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

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
E-mail 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
E-mail clinical.info.jp@kyowakirin.com
Affiliation Kyowa Kirin Co., Ltd.