Clinical trial NCT05007652: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma and Malignant Lymphoma
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-16
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with multiple myeloma.
timeFrame: Day 5, 6, 7
Secondary outcomes:
measure: Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with malignant lymphoma.
timeFrame: Day 1, 4, 5, 6, 7
Other outcomes:
measure: Number of participants with treatment-emergent adverse events (TEAEs)
timeFrame: Day 30 or initiation of radiotherapy or chemotherapy
measure: Serum KRN125 concentrations
timeFrame: Day 30 or initiation of radiotherapy or chemotherapy
measure: Anti-KRN125 antibody
timeFrame: Day 30 or initiation of radiotherapy or chemotherapy
Locations:
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: The Jikei University Kashiwa Hospital
state: Chiba
city: Kitakyushu
country: Japan
facility: Hospital of the University of Occupational and Environmental Health
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido University Hospital of the National University Corporation
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Kanazawa
country: Japan
facility: Ishikawa Prefectural Central Hospital
state: Ishikawa
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Japanese Red Cross Medical Center
state: Tokyo
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kochi
country: Japan
facility: Kochi Health Sciences Center
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
city: Okayama
country: Japan
facility: National Hospital Organization Okayama Medical Center
city: Osaka
country: Japan
facility: Osaka International Cencer Institute
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
Study officials:
References: