Multiple MyelomaPhase 2NCT05294055

Mecapegfilgrastim With Chemotherapy for Peripheral Blood Stem Cell Mobilization in MM and Lymphoma

A Phase 2 study testing Etoposide, Cyclophosphamide and Mecapegfilgrastim, day 2 in people with Multiple Myeloma and Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 7 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

This is a multicenter prospective study to evaluate the efficacy and safety of chemotherapy combined with a single dose of subcutaneous(SC) injection mecapegfilgrastim on day 2 or day 5 after chemotherapy for autologous peripheral blood stem cell (PBSC) mobilization in patients with multiple myeloma or lymphoma. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Multiple Myeloma, Lymphoma
What is being tested?: Etoposide, Cyclophosphamide and Mecapegfilgrastim, day 2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 7 sitesChina
Study dates: 26 Apr 2022to 30 Sep 2026
Phase: Phase 2
Are there results?: Not yet: the study is under way

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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Lymphoma patients with ≤2 lines of prior therapy, patients with multiple myeloma with one line of therapy;
Patients who had achieved at least partial response (PR);
Patients who were eligible for autologous peripheral blood stem cell transplantation
Age≥18 and≤65 years;
Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patients who have an estimated life expectancy of more than three months
Fertile patients must be willing to use reliable contraception during the clinical study period and for 90 days after the last dose and have a negative serological pregnancy test within 72 hours prior to the first dose.
Patients must be able and willing to give written informed consent prior to any study-related procedures

Who cannot join

Patients who had previously attempted hematopoietic stem cell mobilization;
Patients who had undergone previous bone marrow transplantation;
Lymphoma patients with bone marrow involvement or patients with MM who had >10% bone marrow involvement at screening ;
Patients with angina pectoris, myocardial infarction, coronary stent implantation, uncontrolled arrhythmias (atrial tachycardia, atrial fibrillation, persistent ventricular arrhythmias, etc.), cardiac insufficiency, Q-Tc interval >500ms, left ventricular ejection fraction (EF)<60%, or other heart diseases that the investigator considers unsuitable for hematopoietic stem cell mobilization or hematopoietic stem cell transplantation;
Patients with uncontrolled pulmonary infection;
Patients who had any of the following laboratory indicators:

Show all 20Show fewer

White blood cell count(WBC)<2.5×109/L；
Absolute neutrophil count(ANC)<1.5×109/L；
Platelets count(PLT)<80×109/L；
Creatinine > 2.0 X ULN of the reference range or creatinine clearance ≤60ml/min
AST/ALT/Total bilirubin > 2.5 X ULN；
Patients who have received any of the following treatments:
Patients who had been treated with more than 4 cycles of lenalidomide or received lenalidomide within 4 weeks prior to hematopoietic stem cell mobilization chemotherapy.
Patients who previously been treated with fludarabine or melphalan;
Patients who plan to receive radiation within 30 days after transplantation
Patients who had received radiation therapy in the pelvis
Patients allergic to Mecapegfilgrastim, pegylated granulocyte stimulating factor, granulocyte stimulating factor, or other formulations expressed by E. coli.
Patients who are pregnant or breastfeeding
Patients who are participating in other clinical studies or the interval of the last dose of prior study drug to the mobilization chemotherapy is less than 4 weeks (or 5 half-lives of the study drug);
Patients with other conditions unsuitable for this study according to the investigator's judgment.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wei Liu contact

86-022-23909282

liuwei@ihcams.ac.cn

City, postcode or hospital

Sites recruiting now only

7 sites in 1 country

China7 sites, 7 recruiting

Peking University Third Hospital
Beijing, Beijing Municipality
Hongmei Jing
Hongmei Jing
Not yet recruiting
Anhui Provincial Hospital
Hefei, Anhui
Zimin Sun
Zimin Sun
Not yet recruiting
Shandong Cancer Hospital
Jinan, Shandong
Zengjun Li
Zengjun Li
Not yet recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
Wei Liu, MD, 86-022-23909282, liuwei@ihcams.ac.cn
Lugui Qiu, MD
Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality
Yafei Wang
Yafei Wang
Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Rong Fu
Rong Fu
Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Baijun Fang
Baijun Fang
Not yet recruiting

Other trials in China

About this study

Official title: A Prospective and Multicenter Clinical Study of Mecapegfilgrastim in Combination With Chemotherapy for Autologous Peripheral Blood Stem Cell Mobilization in Patients With Multiple Myeloma or Lymphoma

Read the detailed description

Subjects eligible for autologous stem-cell transplantation are randomized to receive a single dose of 12mg mecapegfilgrastim SC on day 2 or day 5 after chemotherapy for PBSC mobilization. According to the protocol, high-dose cyclophosphamide (50mg/kg or 2g/m2, for 2 days) is given to patients with MM, and high-dose etoposide (1.5-1.8g/m2, single dose ) is administered to patients with lymphoma. Apheresis is performed according to the standard institutional regulations. The primary point is to evaluate the percentage of successful mobilization, defined as the cumulative collection of ≥2×10^6/kg CD34+ cells in three or fewer apheresis.

Conditions: Multiple Myeloma, Lymphoma
Being tested: Etoposide, Cyclophosphamide, Mecapegfilgrastim, day 2, Mecapegfilgrastim, day 5
Keywords: peripheral blood stem cell mobilization, Mecapegfilgrastim, chemotherapy
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.

EtoposideDrug
Etoposide 1.5-1.8g/m2, single dose
CyclophosphamideDrug
Cyclophosphamide 50mg/kg or 2g/m2, for 2 days
Mecapegfilgrastim, day 2Drug
Mecapegfilgrastim 12mg SC, on day 2 after chemotherapy
Mecapegfilgrastim, day 5Drug
Mecapegfilgrastim 12mg SC, on day 5 after chemotherapy

Study groups in NCT05294055
Study group	Role	What they receive
lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 2	Experimental	Not described Receives: Drug: Etoposide; Drug: Mecapegfilgrastim, day 2
lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 5	Experimental	Not described Receives: Drug: Etoposide; Drug: Mecapegfilgrastim, day 5
myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 2	Experimental	Not described Receives: Drug: Cyclophosphamide; Drug: Mecapegfilgrastim, day 2
myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 5	Experimental	Not described Receives: Drug: Cyclophosphamide; Drug: Mecapegfilgrastim, day 5

What is being measured

The primary outcome is the main question the study is designed to answer.

percentage of successful mobilization
The percentage of subjects with ≥2×106 cell/kg CD34+ cells were collected.
Measured: up to 28 days since the last subject were given mecapegfilgrastim

Secondary outcomes (4)

the number of the total CD34+ cells
the number of the total CD34+ cells which were collected from each subject
Measured: up to 28 days since the last subject were given mecapegfilgrastim
the number of leukaphereses
the number of leukaphereses needed to collect ≥2×10^6/kg CD34+ cells
Measured: up to 28 days since the last subject were given mecapegfilgrastim
Incidence of febrile neutropenia (FN)
incidence of FN during chemotherapy plus mecapegfilgrastim mobilization
Measured: up to 28 days since the last subject were given mecapegfilgrastim
times to neutrophil and platelet engraftment
times to neutrophil and platelet engraftment after autologous stem cell transplantation
Measured: up to 1 year post-transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Apr 202230 Sep 2026

First posted24 Mar 2022
Study start26 Apr 2022
Primary completion31 Mar 2026 (estimated)
Study completion30 Sep 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05294055
Sponsor's protocol ID: IIT2021036
Status last verified: May 2025
First submitted: 15 Mar 2022
Last updated: 13 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Wei Liu

86-022-23909282

liuwei@ihcams.ac.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective and Multicenter Clinical Study of Mecapegfilgrastim in Combination With Chemotherapy for Autologous Peripheral Blood Stem Cell Mobilization in Patients With Multiple Myeloma or Lymphoma
ClinicalTrials.gov ID: NCT05294055
Acronym / sponsor ID: IIT2021036
Conditions: Multiple Myeloma, Lymphoma
Keywords: peripheral blood stem cell mobilization, Mecapegfilgrastim, chemotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 120 participants (estimated)
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.
Study start: 26 Apr 2022 (actual)
Primary completion: 31 Mar 2026 (estimated)
Study completion: 30 Sep 2026 (estimated)
First posted: 24 Mar 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 2	Experimental	Drug: Etoposide, Drug: Mecapegfilgrastim, day 2
lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 5	Experimental	Drug: Etoposide, Drug: Mecapegfilgrastim, day 5
myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 2	Experimental	Drug: Cyclophosphamide, Drug: Mecapegfilgrastim, day 2
myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 5	Experimental	Drug: Cyclophosphamide, Drug: Mecapegfilgrastim, day 5

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Lymphoma patients with ≤2 lines of prior therapy, patients with multiple myeloma with one line of therapy;
Patients who had achieved at least partial response (PR);
Patients who were eligible for autologous peripheral blood stem cell transplantation
Age≥18 and≤65 years;
Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Key exclusion criteria (20 listed)

Patients who had previously attempted hematopoietic stem cell mobilization;
Patients who had undergone previous bone marrow transplantation;
Lymphoma patients with bone marrow involvement or patients with MM who had >10% bone marrow involvement at screening ;
Patients with angina pectoris, myocardial infarction, coronary stent implantation, uncontrolled arrhythmias (atrial tachycardia, atrial fibrillation, persistent ventricular arrhythmias, etc.), cardiac insufficiency, Q-Tc interval >500ms, left ventricular ejection fraction (EF)<60%, or other heart diseases that the investigator considers unsuitable for hematopoietic stem cell mobilization or hematopoietic stem cell transplantation;
Patients with uncontrolled pulmonary infection;

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
EtoposideEtoposide 1.5-1.8g/m2, single dose	Drug	lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 2, lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 5
CyclophosphamideCyclophosphamide 50mg/kg or 2g/m2, for 2 days	Drug	myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 2, myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 5
Mecapegfilgrastim, day 2Mecapegfilgrastim 12mg SC, on day 2 after chemotherapy	Drug	lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 2, myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 2
Mecapegfilgrastim, day 5Mecapegfilgrastim 12mg SC, on day 5 after chemotherapy	Drug	lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 5, myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 5

Primary outcome

percentage of successful mobilization
Time frame: up to 28 days since the last subject were given mecapegfilgrastim
The percentage of subjects with ≥2×106 cell/kg CD34+ cells were collected.

4 secondary outcomes

the number of the total CD34+ cells
Time frame: up to 28 days since the last subject were given mecapegfilgrastim
the number of leukaphereses
Time frame: up to 28 days since the last subject were given mecapegfilgrastim
Incidence of febrile neutropenia (FN)
Time frame: up to 28 days since the last subject were given mecapegfilgrastim
times to neutrophil and platelet engraftment
Time frame: up to 1 year post-transplantation

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
Individual participant dataSharing planned: No

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

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.

Wei Liu contact

86-022-23909282

liuwei@ihcams.ac.cn

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wei Liu (86-022-23909282, liuwei@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percentage of successful mobilization (time frame: up to 28 days since the last subject were given mecapegfilgrastim). 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 NCT05294055.

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 13 May 2025.