Clinical trial · Interventional
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
NCT05007652CI-TRIAL-00064108completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine if KRN125 is non-inferior to filgrastim for the mobilization of hematopoietic stem cells into the peripheral blood in patients with multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma and Malignant Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KRN125(pegfilgrastim), PLR001(plerixafor) | Drug | — | UNRESOLVED |
| KRN8601(filgrastim), PLR001(plerixafor) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- multiple myeloma cohort (KRN125)
- interventionNames
- Drug: KRN125(pegfilgrastim), PLR001(plerixafor)
- type
- ACTIVE_COMPARATOR
- label
- multiple myeloma cohort (KRN8601)
- interventionNames
- Drug: KRN8601(filgrastim), PLR001(plerixafor)
- type
- EXPERIMENTAL
- label
- malignant lymphoma cohort
- interventionNames
- Drug: KRN125(pegfilgrastim), PLR001(plerixafor)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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: * 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
References
Publications (1)
- DERIVEDGoto H, Sawa M, Fujiwara SI, Ri M, Ishida T, Takeuchi M, Ishitsuka K, Toyosaki M, Sunami K, Tsukada J, Sonoki T, Shimogomi A, Ichihashi Y, Ouchi Y, Miyamoto T, Hino M, Maeda Y, Teshima T. Impact of single dose of pegfilgrastim on peripheral blood stem cell harvest in patients with multiple myeloma or malignant lymphoma. Sci Rep. 2025 Apr 25;15(1):14523. doi: 10.1038/s41598-025-98453-7. PMID 40281003