A Study of KRN125 in Patients With Multiple Myeloma and Malignant Lymphoma
- Conditions
- Multiple Myeloma and Malignant Lymphoma
- Interventions
- Drug: KRN125(pegfilgrastim), PLR001(plerixafor)Drug: KRN8601(filgrastim), PLR001(plerixafor)
- Registration Number
- NCT05007652
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description multiple myeloma cohort (KRN125) KRN125(pegfilgrastim), PLR001(plerixafor) - multiple myeloma cohort (KRN8601) KRN8601(filgrastim), PLR001(plerixafor) - malignant lymphoma cohort KRN125(pegfilgrastim), PLR001(plerixafor) -
- Primary Outcome Measures
Name Time Method Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with multiple myeloma. Day 5, 6, 7
- Secondary Outcome Measures
Name Time Method Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with malignant lymphoma. Day 1, 4, 5, 6, 7
Trial Locations
- Locations (21)
Kochi Health Sciences Center
🇯🇵Kochi, Japan
National Hospital Organization Kumamoto Medical Center
🇯🇵Kumamoto, Japan
Niigata University Medical and Dental Hospital
🇯🇵Niigata, Japan
Osaka International Cencer Institute
🇯🇵Osaka, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Kagoshima University Hospital
🇯🇵Kagoshima, Japan
National Hospital Organization Okayama Medical Center
🇯🇵Okayama, Japan
Chiba Cancer Center
🇯🇵Chiba, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Japanese Red Cross Medical Center
🇯🇵Shibuya-ku, Tokyo, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe, Hyogo, Japan
Kanagawa Cancer Center
🇯🇵Yokohama, Kanagawa, Japan
Nagoya City University Hospital
🇯🇵Nagoya, Aichi, Japan
Ishikawa Prefectural Central Hospital
🇯🇵Kanazawa, Ishikawa, Japan
The Jikei University Kashiwa Hospital
🇯🇵Kashiwa, Chiba, Japan
Hokkaido University Hospital of the National University Corporation
🇯🇵Sapporo, Hokkaido, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke, Tochigi, Japan
Tokai University Hospital
🇯🇵Isehara, Kanagawa, Japan
Hospital of the University of Occupational and Environmental Health
🇯🇵Kitakyushu, Fukuoka, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Wakayama Medical University Hospital
🇯🇵Wakayama, Japan