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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2011210029
Enrollment
64
Registered
2021-08-06
Start date
2021-09-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple myeloma and malignant lymphoma

Interventions

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

Sponsors

Shimogomi Aiko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

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

Secondary

MeasureTime frame
- 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

Contacts

Public ContactClinical trial information contact

Kyowa Kirin Co., Ltd.

clinical.info.jp@kyowakirin.com+81-3-5205-7200

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026