A Study of KRN125 in patients with multiple myeloma and malignant lymphoma
- Conditions
- multiple myeloma and malignant lymphoma
- Registration Number
- JPRN-jRCT2011210029
- Lead Sponsor
- Shimogomi Aiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 64
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Achievement of a target of >= 2*10^6 CD34+ cells/kg collected during apheresis period in patients with multiple myeloma.
- Secondary Outcome Measures
Name Time Method - Achievement of a target of >= 2*10^6 CD34+ cells/kg collected during apheresis period in patients with malignant lymphoma.<br>- Peripheral blood CD34 positive cell count