Skip to main content
OpenTrials
Completed

NCT Number: NCT05007652

A Study of KRN125 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Myeloma and Malignant Lymphoma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nagoya City University Hospital, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KRN125(pegfilgrastim), PLR001(plerixafor)

Drug

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.

KRN8601(filgrastim), PLR001(plerixafor)

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. Number of participants with treatment-emergent adverse events (TEAEs)

    Time frame: Day 30 or initiation of radiotherapy or chemotherapy

  2. Serum KRN125 concentrations

    Time frame: Day 30 or initiation of radiotherapy or chemotherapy

  3. Anti-KRN125 antibody

    Time frame: Day 30 or initiation of radiotherapy or chemotherapy

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2021
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.