Multiple Myeloma and Malignant LymphomaPhase 2NCT05007652
A Study of KRN125 in Patients With Multiple Myeloma and Malignant Lymphoma
A Phase 2 study testing KRN125(pegfilgrastim), PLR001(plerixafor) and KRN8601(filgrastim), PLR001(plerixafor) in people with Multiple Myeloma and Malignant Lymphoma, run by Kyowa Kirin Co., Ltd. at 21 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Multiple Myeloma and Malignant Lymphoma
- What is being tested?
- KRN125(pegfilgrastim), PLR001(plerixafor) and KRN8601(filgrastim), PLR001(plerixafor)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 21 sitesJapan
- Study dates
- 1 Sep 2021to 25 Oct 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
21 sites in 1 country.
21 sites in 1 country
Japan21 sites
Juntendo University Hospital
Bunkyo-ku, Tokyo
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyo-ku, Tokyo
Chiba Cancer Center
Chiba
Kyushu University Hospital
Fukuoka
Tokai University Hospital
Isehara, Kanagawa
Kagoshima University Hospital
Kagoshima
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken
The Jikei University Kashiwa Hospital
Kashiwa, Chiba
Hospital of the University of Occupational and Environmental Health
Kitakyushu, Fukuoka
Kobe City Medical Center General Hospital
Kobe, Hyōgo
Kochi Health Sciences Center
Kochi
National Hospital Organization Kumamoto Medical Center
Kumamoto
Nagoya City University Hospital
Nagoya, Aichi-ken
Niigata University Medical and Dental Hospital
Niigata
National Hospital Organization Okayama Medical Center
Okayama
Osaka International Cencer Institute
Osaka
Hokkaido University Hospital of the National University Corporation
Sapporo, Hokkaido
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo
Jichi Medical University Hospital
Shimotsuke, Tochigi
Wakayama Medical University Hospital
Wakayama
Kanagawa Cancer Center
Yokohama, Kanagawa
About this study
Official title: A Clinical Trial of KRN125 to Mobilize Hematopoietic Stem Cells Into Peripheral Blood 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.
- Conditions
- Multiple Myeloma and Malignant Lymphoma
- Being tested
- KRN125(pegfilgrastim), PLR001(plerixafor), KRN8601(filgrastim), PLR001(plerixafor)
- Medical subject headings
- Multiple Myeloma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| multiple myeloma cohort (KRN125) | Experimental | Not described Receives: Drug: KRN125(pegfilgrastim), PLR001(plerixafor) |
| multiple myeloma cohort (KRN8601) | Active comparator | Not described Receives: Drug: KRN8601(filgrastim), PLR001(plerixafor) |
| malignant lymphoma cohort | Experimental | Not described Receives: Drug: KRN125(pegfilgrastim), PLR001(plerixafor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with multiple myeloma.
Measured: 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.
Measured: Day 1, 4, 5, 6, 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Sep 2021
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Myeloma and Malignant LymphomaStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007652
- Sponsor's protocol ID
- 125-102
- Status last verified
- May 2022
- First submitted
- 2 Aug 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goto H, Sawa M, Fujiwara SI, Ri M, Ishida T, Takeuchi M, Ishitsuka K, Toyosaki M, Sunami K, Tsukada J, Sonoki T, Shimogomi A, Ichihashi Y, Ouchi Y, Miyamoto T, Hino M, Maeda Y, Teshima T. Impact of single dose of pegfilgrastim on peripheral blood stem cell harvest in patients with multiple myeloma or malignant lymphoma. Sci Rep. 2025 Apr 25;15(1):14523. doi: 10.1038/s41598-025-98453-7.
PubMed 40281003
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of KRN125 to Mobilize Hematopoietic Stem Cells Into Peripheral Blood in Patients With Multiple Myeloma and Malignant Lymphoma
- ClinicalTrials.gov ID
- NCT05007652
- Acronym / sponsor ID
- 125-102
- Conditions
- Multiple Myeloma and Malignant Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| multiple myeloma cohort (KRN125) | Experimental | Drug: KRN125(pegfilgrastim), PLR001(plerixafor) |
| multiple myeloma cohort (KRN8601) | Active comparator | Drug: KRN8601(filgrastim), PLR001(plerixafor) |
| malignant lymphoma cohort | Experimental | Drug: KRN125(pegfilgrastim), PLR001(plerixafor) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | malignant lymphoma cohort, multiple myeloma cohort (KRN125) |
| 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. | Drug | multiple myeloma cohort (KRN8601) |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Derived from this study: PubMed 40281003Goto H, Sawa M, Fujiwara SI, Ri M, Ishida T, Takeuchi M, Ishitsuka K, Toyosaki M, Sunami K, Tsukada J, Sonoki T, Shimogomi A, Ichihashi Y, Ouchi Y, Miyamoto T, Hino M, Maeda Y, Teshima T. Impact of single dose of pegfilgrastim on peripheral blood stem cell harvest in patients with multiple myeloma or malignant lymphoma. Sci Rep. 2025 Apr 25;15(1):14523. doi: 10.1038/s41598-025-98453-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KRN125(pegfilgrastim), PLR001(plerixafor) and KRN8601(filgrastim), PLR001(plerixafor) in people with Multiple Myeloma and Malignant Lymphoma, run by Kyowa Kirin Co., Ltd. at 21 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05007652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.