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

February 19, 2023 updated by: Kyowa Kirin Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan
        • Chiba Cancer Center
      • Fukuoka, Japan
        • Kyushu University Hospital
      • Kagoshima, Japan
        • Kagoshima University Hospital
      • Kochi, Japan
        • Kochi Health Sciences Center
      • Kumamoto, Japan
        • National Hospital Organization Kumamoto Medical Center
      • Niigata, Japan
        • Niigata University Medical and Dental Hospital
      • Okayama, Japan
        • National Hospital Organization Okayama Medical Center
      • Osaka, Japan
        • Osaka International Cencer Institute
      • Wakayama, Japan
        • Wakayama Medical University Hospital
    • Aichi
      • Nagoya, Aichi, Japan
        • Nagoya City University Hospital
    • Chiba
      • Kashiwa, Chiba, Japan
        • The Jikei University Kashiwa Hospital
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan
        • Hospital of the University of Occupational and Environmental Health
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Hokkaido University Hospital of the National University Corporation
    • Hyogo
      • Kobe, Hyogo, Japan
        • Kobe City Medical Center General Hospital
    • Ishikawa
      • Kanazawa, Ishikawa, Japan
        • Ishikawa Prefectural Central Hospital
    • Kanagawa
      • Isehara, Kanagawa, Japan
        • Tokai University Hospital
      • Yokohama, Kanagawa, Japan
        • Kanagawa cancer center
    • Tochigi
      • Shimotsuke, Tochigi, Japan
        • Jichi Medical University Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • Juntendo University Hospital
      • Bunkyo-ku, Tokyo, Japan
        • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
      • Shibuya-ku, Tokyo, Japan
        • Japanese Red Cross Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: multiple myeloma cohort (KRN125)
Drug: KRN125(pegfilgrastim), PLR001(plerixafor)
7.2 mg of KRN125 in Day 1 Single subcutaneous administration The concomitant drug PLR001 is administered subcutaneously once daily at a dose of 0.24 mg/kg when meets the criteria. The dosing period is 12-9 hours before apheresis on the following day.
Active Comparator: multiple myeloma cohort (KRN8601)
Drug: KRN8601(filgrastim), PLR001(plerixafor)
400 ug/m2 of KRN8601 from Day 1 to the end date of the Apheresis Once daily subcutaneous administration The concomitant drug PLR001 is administered subcutaneously once daily at a dose of 0.24 mg/kg when meets the criteria. The dosing period is 12-9 hours before apheresis on the following day.
Experimental: malignant lymphoma cohort
Drug: KRN125(pegfilgrastim), PLR001(plerixafor)
7.2 mg of KRN125 in Day 1 Single subcutaneous administration The concomitant drug PLR001 is administered subcutaneously once daily at a dose of 0.24 mg/kg when meets the criteria. The dosing period is 12-9 hours before apheresis on the following day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 5, 6, 7

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day 1, 4, 5, 6, 7

Other Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame: Day 30 or initiation of radiotherapy or chemotherapy
Day 30 or initiation of radiotherapy or chemotherapy
Serum KRN125 concentrations
Time Frame: Day 30 or initiation of radiotherapy or chemotherapy
Day 30 or initiation of radiotherapy or chemotherapy
Anti-KRN125 antibody
Time Frame: Day 30 or initiation of radiotherapy or chemotherapy
Day 30 or initiation of radiotherapy or chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

October 25, 2022

Study Completion (Actual)

October 25, 2022

Study Registration Dates

First Submitted

August 2, 2021

First Submitted That Met QC Criteria

August 10, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 19, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 125-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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