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

Sponsor

Kyowa Kirin Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05007652

Collaborator

(none)

Enrollment

Locations

Arms

13.7

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma and Malignant Lymphoma	Drug: KRN125(pegfilgrastim), PLR001(plerixafor) Drug: KRN8601(filgrastim), PLR001(plerixafor)	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 10, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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.

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)

Outcome Measures

Primary Outcome Measures

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

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]

Other Outcome Measures

Number of participants with treatment-emergent adverse events (TEAEs) [Day 30 or initiation of radiotherapy or chemotherapy]
Serum KRN125 concentrations [Day 30 or initiation of radiotherapy or chemotherapy]
Anti-KRN125 antibody [Day 30 or initiation of radiotherapy or chemotherapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Nagoya City University Hospital	Nagoya	Aichi	Japan
2	The Jikei University Kashiwa Hospital	Kashiwa	Chiba	Japan
3	Hospital of the University of Occupational and Environmental Health	Kitakyushu	Fukuoka	Japan
4	Hokkaido University Hospital of the National University Corporation	Sapporo	Hokkaido	Japan
5	Kobe City Medical Center General Hospital	Kobe	Hyogo	Japan
6	Ishikawa Prefectural Central Hospital	Kanazawa	Ishikawa	Japan
7	Tokai University Hospital	Isehara	Kanagawa	Japan
8	Kanagawa Cancer Center	Yokohama	Kanagawa	Japan
9	Jichi Medical University Hospital	Shimotsuke	Tochigi	Japan
10	Juntendo University Hospital	Bunkyo-ku	Tokyo	Japan
11	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital	Bunkyo-ku	Tokyo	Japan
12	Japanese Red Cross Medical Center	Shibuya-ku	Tokyo	Japan
13	Chiba Cancer Center	Chiba		Japan
14	Kyushu University Hospital	Fukuoka		Japan
15	Kagoshima University Hospital	Kagoshima		Japan
16	Kochi Health Sciences Center	Kochi		Japan
17	National Hospital Organization Kumamoto Medical Center	Kumamoto		Japan
18	Niigata University Medical and Dental Hospital	Niigata		Japan
19	National Hospital Organization Okayama Medical Center	Okayama		Japan
20	Osaka International Cencer Institute	Osaka		Japan
21	Wakayama Medical University Hospital	Wakayama		Japan

Sponsors and Collaborators

Kyowa Kirin Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kyowa Kirin Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05007652

Other Study ID Numbers:

125-102

First Posted:

Aug 16, 2021

Last Update Posted:

May 23, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Plerixafor

Study Results

No Results Posted as of May 23, 2022