Clinical Trials /

A Study of KRN125 in Patients With Multiple Myeloma and Malignant Lymphoma

NCT05007652

Description:

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.

Related Conditions:
  • Lymphoma
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of KRN125 in Patients With Multiple Myeloma and Malignant Lymphoma
  • Official Title: A Clinical Trial of KRN125 to Mobilize Hematopoietic Stem Cells Into Peripheral Blood in Patients With Multiple Myeloma and Malignant Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: 125-102
  • NCT ID: NCT05007652

Conditions

  • Multiple Myeloma and Malignant Lymphoma

Interventions

DrugSynonymsArms
KRN125(pegfilgrastim), PLR001(plerixafor)malignant lymphoma cohort
KRN8601(filgrastim), PLR001(plerixafor)multiple myeloma cohort (KRN8601)

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
multiple myeloma cohort (KRN125)Experimental
  • KRN125(pegfilgrastim), PLR001(plerixafor)
multiple myeloma cohort (KRN8601)Active Comparator
  • KRN8601(filgrastim), PLR001(plerixafor)
malignant lymphoma cohortExperimental
  • KRN125(pegfilgrastim), PLR001(plerixafor)

Eligibility 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:

          -  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
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with multiple myeloma.
Time Frame:Day 5, 6, 7
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with malignant lymphoma.
Time Frame:Day 1, 4, 5, 6, 7
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Kyowa Kirin Co., Ltd.

Last Updated

August 16, 2021