Menu. Menu.

Clinical Trial Finder

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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 20 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05007652
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Kyowa Kirin Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Multiple Myeloma and Malignant Lymphoma
Arms & Interventions

Arms

Experimental: multiple myeloma cohort (KRN125)

Active Comparator: multiple myeloma cohort (KRN8601)

Experimental: malignant lymphoma cohort

Interventions

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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Nagoya City University Hospital, Nagoya, Aichi, Japan

Status

Recruiting

Address

Nagoya City University Hospital

Nagoya, Aichi,

The Jikei University Kashiwa Hospital, Kashiwa, Chiba, Japan

Status

Recruiting

Address

The Jikei University Kashiwa Hospital

Kashiwa, Chiba,

Kitakyushu, Fukuoka, Japan

Status

Recruiting

Address

Hospital of the University of Occupational and Environmental Health

Kitakyushu, Fukuoka,

Sapporo, Hokkaido, Japan

Status

Recruiting

Address

Hokkaido University Hospital of the National University Corporation

Sapporo, Hokkaido,

Kobe, Hyogo, Japan

Status

Recruiting

Address

Kobe City Medical Center General Hospital

Kobe, Hyogo,

Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan

Status

Recruiting

Address

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa,

Tokai University Hospital, Isehara, Kanagawa, Japan

Status

Recruiting

Address

Tokai University Hospital

Isehara, Kanagawa,

Kanagawa Cancer Center, Yokohama, Kanagawa, Japan

Status

Recruiting

Address

Kanagawa Cancer Center

Yokohama, Kanagawa,

Jichi Medical University Hospital, Shimotsuke, Tochigi, Japan

Status

Recruiting

Address

Jichi Medical University Hospital

Shimotsuke, Tochigi,

Juntendo University Hospital, Bunkyo-ku, Tokyo, Japan

Status

Recruiting

Address

Juntendo University Hospital

Bunkyo-ku, Tokyo,

Bunkyo-ku, Tokyo, Japan

Status

Recruiting

Address

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyo-ku, Tokyo,

Japanese Red Cross Medical Center, Shibuya-ku, Tokyo, Japan

Status

Recruiting

Address

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo,

Chiba Cancer Center, Chiba, Japan

Status

Recruiting

Address

Chiba Cancer Center

Chiba, ,

Kyushu University Hospital, Fukuoka, Japan

Status

Recruiting

Address

Kyushu University Hospital

Fukuoka, ,

Kagoshima University Hospital, Kagoshima, Japan

Status

Recruiting

Address

Kagoshima University Hospital

Kagoshima, ,

Kochi Health Sciences Center, Kochi, Japan

Status

Recruiting

Address

Kochi Health Sciences Center

Kochi, ,

Kumamoto, Japan

Status

Recruiting

Address

National Hospital Organization Kumamoto Medical Center

Kumamoto, ,

Niigata, Japan

Status

Recruiting

Address

Niigata University Medical and Dental Hospital

Niigata, ,

Okayama, Japan

Status

Recruiting

Address

National Hospital Organization Okayama Medical Center

Okayama, ,

Osaka International Cencer Institute, Osaka, Japan

Status

Recruiting

Address

Osaka International Cencer Institute

Osaka, ,

Wakayama Medical University Hospital, Wakayama, Japan

Status

Recruiting

Address

Wakayama Medical University Hospital

Wakayama, ,

Powered By