Multiple MyelomaNCT05517213
High-dose Chemotherapy+G-CSF in Peripheral Blood Stem Cell Mobilization in Patients With Multiple Myeloma
A study testing Etoposide and Cyclophosphamide in people with Multiple Myeloma, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
This study was a multi-center, randomized, prospective study. The purpose is to clarify that high-dose VP-16+G-CSF has better mobilization efficiency and less toxic and side effects compared with high-dose CTX+G-CSF, and minimize mobilization failure, so as to provide convenient and high-quality mobilization programs… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Etoposide and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 30 Dec 2024
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed MM patients: patients who were initially diagnosed and treated, who were suitable for autologous transplantation and planned to be treated with ASCT;
- Age limitation: 18-70 years old patients; ④ Physical status: ECOG physical status score was 0 or 1; ⑤ The adverse reactions caused by chemotherapy had recovered: peripheral blood leukocytes ≥3.0×109/L, hemoglobin ≥80g/L, platelet ≥80×109/L; Liver function glutamic-pyruvic transaminase and glutamic-oxalacetic transaminase ≤ 2 times the upper limit of normal value, total bilirubin ≤ 1.5 times the upper limit of normal value, serum creatinine ≤ 1.5 times the upper limit of normal value, chest CT normal, ecg normal; (5) Patients participate voluntarily and informed consent is signed by patients themselves (or their legal representatives); Take effective contraceptive measures during the childbearing age.
Who cannot join
- ① According to the clinical judgment of the researcher: According to NCI CTCAE (4th edition May 28, 2009), patients with ≥3 grade cardiopulmonary insufficiency and severe kidney disease, currently diagnosed as coronary heart disease, myocardial infarction, arrhythmia, glutamic-oxalacetic transaminase, glutamic-pyruvic transaminase ≥ 2 times the upper limit of normal value, Total bilirubin ≥ 1.5 times the upper limit of normal;
- With active infection, including fever of unknown cause (axillary temperature > 37.5℃); ③ Patients with severe history of mental system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-dose Etoposide +G-CSF Versus High-dose Cyclophosphamide +G-CSF in Peripheral Blood Stem Cell Mobilization in Patients With Multiple Myeloma：a Multicenter,Randomized,Prospective Study
This study was a multi-center, randomized, prospective study. The purpose is to clarify that high-dose VP-16+G-CSF has better mobilization efficiency and less toxic and side effects compared with high-dose CTX+G-CSF, and minimize mobilization failure, so as to provide convenient and high-quality mobilization programs for clinical practice and enable more patients to enter the transplantation stage smoothly.
Read the detailed description
Autologous peripheral blood hematopoietic stem cell mobilization: the two regiments were VP-16 1.2g/m2+rhG-CSF 10ug·kg-1·d-1 and CTX 3.0g/m2+rhG-CSF 10ug·kg-1·d-1; After high-dose chemotherapy, RHG-CSF 5ug/kg Bid was injected subcutaneously until the end of stem cell collection when the white blood cell count decreased to the minimum and began to rise steadily, and the platelet count was ≥50×109/L. Vp-16 was used as pure liquid continuously pumped for 24h. Dexamethasone 10mg was given before use, and blood pressure was monitored during use. During the use of CTX, it should be hydrated and alkalized, and mesic sodium (total amount 1.0-1.2 times CTX, divided into three static drops) should be used. Apheresis was performed once a day from the 5th day of RHG-CSF application, and the circulating blood volume was 2-3 times of the blood volume each time, and apheresis was performed at most 3 times. The percentage of CD34+ cells in the collection was determined by FCM, and the volume of the collection, the total number of nucleated cells per kg body weight and the number of CD34+ cells were recorded. For some patients whose apheresis is not up to the standard, they can be mobilized again after 1 month of rest, and chemotherapy +rhG-CSF mobilization or rhG-CSF+ ploxafo steady-state mobilization can be used.
- Conditions
- Multiple Myeloma
- Being tested
- Etoposide, Cyclophosphamide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoposideDrug
Also called VP-16
Chemotherapy combined with rhG-CSF is widely used in autologous hematopoietic stem cell mobilization programs. For patients who do not meet the criteria of stem cell collection, they can be mobilized again after 1 month of rest. Chemotherapy +rhG-CSF mobilization or rhG-CSF+ ploxafo steady-state mobilization can be used.
CyclophosphamideDrug
Also called CTX
Chemotherapy combined with rhG-CSF is widely used in autologous hematopoietic stem cell mobilization programs. For patients who do not meet the criteria of stem cell collection, they can be mobilized again after 1 month of rest. Chemotherapy +rhG-CSF mobilization or rhG-CSF+ ploxafo steady-state mobilization can be used.
| Study group | Role | What they receive |
|---|---|---|
| Etoposide | Experimental | Etoposide1.2g/m2(Pump continuously for 24h)+G-CSF10ug/kg. Receives: Drug: Etoposide |
| Cyclophosphamide | Experimental | Cyclophosphamide 3.0g/m2+Grh-CSF10ug/kg. Receives: Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main purpose
Compared with the literature data, The primary efficacy endpoint was the difference in the proportion of patients who reached the target CD34+ cells ≥5×106/kg and CD34+ cells ≥5×106/kg within 3 days of monotherapy between the study group and the control group.
Measured: Enrollment is expected to last for one year, followed up for two years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Sep 2022
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
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 MyelomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All patients were randomly assigned 1:1 to CTX 3.0g/m2+ G-CSF 10ug/kg or VP-16 1.2g/m2+G-CSF10ug/kg
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517213
- Sponsor's protocol ID
- 307-947168-89
- Status last verified
- Sep 2025
- First submitted
- 24 Aug 2022
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun Y, Li J, Dong Y, Li M, Wang Y, Chen X, Yuan S, Lu Y, Ma Y, Chen J, Gao W, Huang W, Liu Y, Xiao X. A randomized comparison of etoposide and cyclophosphamide for stem cell mobilization in newly diagnosed multiple myeloma. Sci Rep. 2026 Apr 2;16(1):15790. doi: 10.1038/s41598-026-46787-1.
PubMed 41927700
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Etoposide +G-CSF Versus High-dose Cyclophosphamide +G-CSF in Peripheral Blood Stem Cell Mobilization in Patients With Multiple Myeloma：a Multicenter,Randomized,Prospective Study
- ClinicalTrials.gov ID
- NCT05517213
- Acronym / sponsor ID
- 307-947168-89
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 26 Aug 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.
This study was a multi-center, randomized, prospective study. The purpose is to clarify that high-dose VP-16+G-CSF has better mobilization efficiency and less toxic and side effects compared with high-dose CTX+G-CSF, and minimize mobilization failure, so as to provide convenient and high-quality mobilization programs for clinical practice and enable more patients to enter the transplantation stage smoothly.
Detailed description
Autologous peripheral blood hematopoietic stem cell mobilization: the two regiments were VP-16 1.2g/m2+rhG-CSF 10ug·kg-1·d-1 and CTX 3.0g/m2+rhG-CSF 10ug·kg-1·d-1; After high-dose chemotherapy, RHG-CSF 5ug/kg Bid was injected subcutaneously until the end of stem cell collection when the white blood cell count decreased to the minimum and began to rise steadily, and the platelet count was ≥50×109/L. Vp-16 was used as pure liquid continuously pumped for 24h. Dexamethasone 10mg was given before use, and blood pressure was monitored during use. During the use of CTX, it should be hydrated and alkalized, and mesic sodium (total amount 1.0-1.2 times CTX, divided into three static drops) should be used. Apheresis was performed once a day from the 5th day of RHG-CSF application, and the circulating blood volume was 2-3 times of the blood volume each time, and apheresis was performed at most 3 times. The percentage of CD34+ cells in the collection was determined by FCM, and the volume of the collection, the total number of nucleated cells per kg body weight and the number of CD34+ cells were recorded. For some patients whose apheresis is not up to the standard, they can be mobilized again after 1 month of rest, and chemotherapy +rhG-CSF mobilization or rhG-CSF+ ploxafo steady-state mobilization can be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients were randomly assigned 1:1 to CTX 3.0g/m2+ G-CSF 10ug/kg or VP-16 1.2g/m2+G-CSF10ug/kg
| Arm | Type | Receives |
|---|---|---|
| Etoposide | Experimental | Drug: EtoposideEtoposide1.2g/m2(Pump continuously for 24h)+G-CSF10ug/kg. |
| Cyclophosphamide | Experimental | Drug: CyclophosphamideCyclophosphamide 3.0g/m2+Grh-CSF10ug/kg. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed MM patients: patients who were initially diagnosed and treated, who were suitable for autologous transplantation and planned to be treated with ASCT;
Key exclusion criteria (2 listed)
- ① According to the clinical judgment of the researcher: According to NCI CTCAE (4th edition May 28, 2009), patients with ≥3 grade cardiopulmonary insufficiency and severe kidney disease, currently diagnosed as coronary heart disease, myocardial infarction, arrhythmia, glutamic-oxalacetic transaminase, glutamic-pyruvic transaminase ≥ 2 times the upper limit of normal value, Total bilirubin ≥ 1.5 times the upper limit of normal;
- With active infection, including fever of unknown cause (axillary temperature > 37.5℃); ③ Patients with severe history of mental system.
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 |
|---|---|---|
| EtoposideAlso: VP-16Chemotherapy combined with rhG-CSF is widely used in autologous hematopoietic stem cell mobilization programs. For patients who do not meet the criteria of stem cell collection, they can be mobilized again after 1 month of rest. Chemotherapy +rhG-CSF mobilization or rhG-CSF+ ploxafo steady-state mobilization can be used. | Drug | Etoposide |
| CyclophosphamideAlso: CTXChemotherapy combined with rhG-CSF is widely used in autologous hematopoietic stem cell mobilization programs. For patients who do not meet the criteria of stem cell collection, they can be mobilized again after 1 month of rest. Chemotherapy +rhG-CSF mobilization or rhG-CSF+ ploxafo steady-state mobilization can be used. | Drug | Cyclophosphamide |
Primary outcome
Main purpose
Time frame: Enrollment is expected to last for one year, followed up for two years.
Compared with the literature data, The primary efficacy endpoint was the difference in the proportion of patients who reached the target CD34+ cells ≥5×106/kg and CD34+ cells ≥5×106/kg within 3 days of monotherapy between the study group and the control group.
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 2 Oct 2025.
- Derived from this study: PubMed 41927700Sun Y, Li J, Dong Y, Li M, Wang Y, Chen X, Yuan S, Lu Y, Ma Y, Chen J, Gao W, Huang W, Liu Y, Xiao X. A randomized comparison of etoposide and cyclophosphamide for stem cell mobilization in newly diagnosed multiple myeloma. Sci Rep. 2026 Apr 2;16(1):15790. doi: 10.1038/s41598-026-46787-1.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etoposide and Cyclophosphamide in people with Multiple Myeloma, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
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 2 inclusion and 2 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 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Main purpose (time frame: Enrollment is expected to last for one year, followed up for two years.). 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 NCT05517213, 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 2 Oct 2025.