Multiple MyelomaPhase 3NCT06520176
Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients
A Phase 3 study testing Etoposide, Cytarabine and Pegfilgrastim in people with Multiple Myeloma and Hematopoietic Stem Cell Mobilization, run by The Affiliated People's Hospital of Ningbo University at 16 sites in China.
Trial summary
This is a prospective, randomized, two-arm, multicenter, exploratory study aimed at evaluating the efficacy and safety of the combination of etoposide, cytarabine and Pegfilgrastim (EAP regimen) for mobilizing hematopoietic stem cells in patients with newly diagnosed multiple myeloma (NDMM). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma, Hematopoietic Stem Cell Mobilization
- What is being tested?
- Etoposide, Cytarabine and Pegfilgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 16 sitesChina
- Study dates
- Aug 2024to Dec 2026
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients newly diagnosed as multiple myeloma.
- 2. Indication for ASCT.
- 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0~1.
- 4. Life expectancy ≥ 3 months.
- 5. Subjects must be able to understand the protocol and sign the informed consent.
Who cannot join
- 1. Cardiac function class II or higher or cardiac ejection fraction <40%.
- 2. Serum direct bilirubin (DBIL)>2× upper limit of normal (ULN).
- 3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3× ULN.
- 4. Serum creatinine clearance rate≤30%.
- 5. Patients with active infection.
- 6. Previously received hematopoietic stem cell mobilization.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
China16 sites, 16 recruiting
- Recruiting
Dongyang People's Hospital
Dongyang, Zhejiang
Gongqiang Wu, 13757950788, Wugongqiang59@126.com
- Recruiting
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang
Jie Jin, 13507016779, jiej0503@163.com
- Recruiting
Tongde Hospital of Zhejiang Province
Hangzhou, Zhejiang
Huifang Jiang, 13957182087, Jianghuifang501@163.com
- Recruiting
Huzhou central hospital
Huzhou, Zhejiang
Lihong Shou, 13587206019, SLH077@126.COM
- Recruiting
The First Hospital of Jiaxing
Jiaxing, Zhejiang
Hui Zeng, 13957330440, zhwuhan@163.com
- Recruiting
Jinhua Municipal Central Hospital
Jinhua, Zhejiang
Jingcheng Zhang, 13958480529, zjc1983@126.com
- Recruiting
Jinhua People's Hospital
Jinhua, Zhejiang
Li Huang, 13566782316, huanglixiaoyu@126.com
- Recruiting
Lishui Central Hospital
Lishui, Zhejiang
Linjie Li, 13567615761, Lilinjie0394@163.com
- Recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang
Jing Le, 13566511755, nblejing@aliyun.com
- Recruiting
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang
Ying Lu, +86-13486090834, 814871416@qq.com
Peipei Ye, +86-13685832706, 39612903@qq.com
- Recruiting
Shaoxing People's Hospital
Shaoxing, Zhejiang
Weiying Feng, 13588570250, fengweiying1997@126.com
- Recruiting
Shaoxing Second Hospital
Shaoxing, Zhejiang
Weiguo Zhu, 18767509030, yin990216@sina.com
- Recruiting
Taizhou Central Hospital
Taizhou, Zhejiang
Sai Chen, 13575809591, chens7111@tzzxyy.com
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
Qunyi Guo, 13515861286, guoqunyi@163.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Shujuan Zhou, 13738368586, Zhousj320@163.com
- Recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Ying Lin, 13705883857, wzly1974@hotmail.com
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Study of Etoposide, Cytarabine Combined With Pegfilgrastim vs. Cyclophosphamide Combined With G-CSF for Hematopoietic Stem Cell Mobilization in Newly Diagnosed Multiple Myeloma Patients
This is a prospective, randomized, two-arm, multicenter, exploratory study aimed at evaluating the efficacy and safety of the combination of etoposide, cytarabine and Pegfilgrastim (EAP regimen) for mobilizing hematopoietic stem cells in patients with newly diagnosed multiple myeloma (NDMM). A total of 99 NDMM patients will be enrolled and randomly assigned to receive either the EAP regimen or the GC regimen (cyclophosphamide+ G-CSF) to mobilize hematopoietic stem cells. Subsequently, the mobilization effects and adverse reactions of all patients will be observed and compared.
Read the detailed description
According to strict inclusion and exclusion criteria, 99 newly diagnosed MM patients will be selected. They will be randomly assigned in a 2:1 ratio to the EAP group or the CG group. During the hematopoietic stem cell mobilization period, comparison study will be conducted regarding the proportion of patients who achieve the ideal collection value (CD34 cells >5×10^6/kg) after a single collection; the proportion of patients who cumulatively achieve the target collection value (CD34 cells >2×10^6/kg) and the ideal collection value; the cumulative collection of CD34 cells and the average number of collections; and the hematological and non-hematological adverse reactions of the EAP and CG regimens. Special attention will be given to the proportion of patients who add Plerixafor in both regimens.
- Being tested
- Etoposide, Cytarabine, Pegfilgrastim, Cyclophosphamide, G-CSF
- Keywords
- Multiple Myeloma, Etoposide, Cytarabine, PEG-rhG-CSF, Hematopoietic Stem Cell Mobilization
- 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
Day 1~Day 2: 75mg/m^2
CytarabineDrug
Also called Ara-C
Day 1~Day 2: 200g/m^2, q12h
PegfilgrastimDrug
Also called PEG-rhG-CSF
Day 6: 6mg
CyclophosphamideDrug
Also called Cy
Day 1~Day 2: 1～2g/m^2
G-CSFDrug
Also called Granulocyte Colony Stimulating Factor
Subcutaneous injection at dose 5ug/kg, from day 6 until the end of mobilization.
G-CSFDrug
Also called Granulocyte Colony Stimulating Factor
Starting from the 9th day, if the white blood cell count is less than 20,000/μL, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed.
| Study group | Role | What they receive |
|---|---|---|
| EAP regimen group | Experimental | 66 subjects will be enrolled into the EAP regimen group. EAP regimen is the combination of etoposide, cytarabine and PEG-rhG-CSF. Receives: Drug: Etoposide; Drug: Cytarabine; Drug: Pegfilgrastim; Drug: G-CSF |
| CG regimen group | Active comparator | 33 subjects will be enrolled into the CG regimen group. CG regimen is the combination of cyclophosphamide and G-CSF. Receives: Drug: Cyclophosphamide; Drug: G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients achieving the collection of ≥5×10^6 CD34+ cells/kg
Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10^6/kg) after a single collection
Measured: 1 month
Secondary outcomes (4)
% of patients achieving the collection of ≥2×10^6 CD34+ cells/kg
Comparison of the cumulative proportion of patients who achieve the target collection value (CD34+ cells ≥2×10^6/kg) between the EAP and CG regimens; the proportion of patients who achieve the ideal collection value.
Measured: 1 month
CD34+ cells and the average number of collections
Comparison of the total amount of CD34+ cells collected and the average number of collections between the EAP and CG regimens.
Measured: 1 month
Adverse Rvents (AEs)
Comparison of hematological and non-hematological adverse reactions between the EAP and CG regimens.
Measured: 1 month
% of patients who use Plerixafor
Comparison of the proportion of patients who add Plerixafor between the EAP and CG regimens.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, two-arm, multicenter, exploratory study
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated People's Hospital of Ningbo University
- Sponsor type
- Other government
- Collaborators
- First Affiliated Hospital of Zhejiang University, First Affiliated Hospital of Wenzhou Medical University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Central Hospital of Lishui City, Jinhua People's Hospital, Shaoxing People's Hospital, Shaoxing Second Hospital, Zhejiang Provincial Tongde Hospital, Taizhou Hospital, Dongyang People's Hospital, Affiliated Hospital of Jiaxing University, Huizhou Municipal Central Hospital, Second Affiliated Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital, Jinhua Municipal Central Hospital
- Responsible party
- Sponsor
- Investigators
- Ying Lu, Principal investigator, The Affiliated People's Hospital of Ningbo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520176
- Sponsor's protocol ID
- 2024-060
- Status last verified
- Jul 2024
- First submitted
- 20 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Study of Etoposide, Cytarabine Combined With Pegfilgrastim vs. Cyclophosphamide Combined With G-CSF for Hematopoietic Stem Cell Mobilization in Newly Diagnosed Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT06520176
- Acronym / sponsor ID
- 2024-060
- Keywords
- Multiple Myeloma, Etoposide, Cytarabine, PEG-rhG-CSF, Hematopoietic Stem Cell Mobilization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- The Affiliated People's Hospital of Ningbo UniversityOther government
- Collaborators
- First Affiliated Hospital of Zhejiang University, First Affiliated Hospital of Wenzhou Medical University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Central Hospital of Lishui City, Jinhua People's Hospital, Shaoxing People's Hospital, Shaoxing Second Hospital, Zhejiang Provincial Tongde Hospital, Taizhou Hospital, Dongyang People's Hospital, Affiliated Hospital of Jiaxing University, Huizhou Municipal Central Hospital, Second Affiliated Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital, Jinhua Municipal Central Hospital
- Study start
- Aug 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Jul 2024 (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 is a prospective, randomized, two-arm, multicenter, exploratory study aimed at evaluating the efficacy and safety of the combination of etoposide, cytarabine and Pegfilgrastim (EAP regimen) for mobilizing hematopoietic stem cells in patients with newly diagnosed multiple myeloma (NDMM). A total of 99 NDMM patients will be enrolled and randomly assigned to receive either the EAP regimen or the GC regimen (cyclophosphamide+ G-CSF) to mobilize hematopoietic stem cells. Subsequently, the mobilization effects and adverse reactions of all patients will be observed and compared.
Detailed description
According to strict inclusion and exclusion criteria, 99 newly diagnosed MM patients will be selected. They will be randomly assigned in a 2:1 ratio to the EAP group or the CG group. During the hematopoietic stem cell mobilization period, comparison study will be conducted regarding the proportion of patients who achieve the ideal collection value (CD34 cells >5×10^6/kg) after a single collection; the proportion of patients who cumulatively achieve the target collection value (CD34 cells >2×10^6/kg) and the ideal collection value; the cumulative collection of CD34 cells and the average number of collections; and the hematological and non-hematological adverse reactions of the EAP and CG regimens. Special attention will be given to the proportion of patients who add Plerixafor in both regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, two-arm, multicenter, exploratory study
| Arm | Type | Receives |
|---|---|---|
| EAP regimen group | Experimental | Drug: Etoposide, Drug: Cytarabine, Drug: Pegfilgrastim, Drug: G-CSF66 subjects will be enrolled into the EAP regimen group. EAP regimen is the combination of etoposide, cytarabine and PEG-rhG-CSF. |
| CG regimen group | Active comparator | Drug: Cyclophosphamide, Drug: G-CSF33 subjects will be enrolled into the CG regimen group. CG regimen is the combination of cyclophosphamide and G-CSF. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Patients newly diagnosed as multiple myeloma.
- 2. Indication for ASCT.
- 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0~1.
- 4. Life expectancy ≥ 3 months.
- 5. Subjects must be able to understand the protocol and sign the informed consent.
Key exclusion criteria (6 listed)
- 1. Cardiac function class II or higher or cardiac ejection fraction <40%.
- 2. Serum direct bilirubin (DBIL)>2× upper limit of normal (ULN).
- 3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3× ULN.
- 4. Serum creatinine clearance rate≤30%.
- 5. Patients with active 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 |
|---|---|---|
| EtoposideAlso: VP-16Day 1~Day 2: 75mg/m^2 | Drug | EAP regimen group |
| CytarabineAlso: Ara-CDay 1~Day 2: 200g/m^2, q12h | Drug | EAP regimen group |
| PegfilgrastimAlso: PEG-rhG-CSFDay 6: 6mg | Drug | EAP regimen group |
| CyclophosphamideAlso: CyDay 1~Day 2: 1～2g/m^2 | Drug | CG regimen group |
| G-CSFAlso: Granulocyte Colony Stimulating FactorSubcutaneous injection at dose 5ug/kg, from day 6 until the end of mobilization. | Drug | CG regimen group |
| G-CSFAlso: Granulocyte Colony Stimulating FactorStarting from the 9th day, if the white blood cell count is less than 20,000/μL, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed. | Drug | EAP regimen group |
Primary outcome
% of patients achieving the collection of ≥5×10^6 CD34+ cells/kg
Time frame: 1 month
Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10^6/kg) after a single collection
4 secondary outcomes
% of patients achieving the collection of ≥2×10^6 CD34+ cells/kg
Time frame: 1 month
CD34+ cells and the average number of collections
Time frame: 1 month
Adverse Rvents (AEs)
Time frame: 1 month
% of patients who use Plerixafor
Time frame: 1 month
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 25 Jul 2024.
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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.
Ying Lu principal investigator
The Affiliated People's Hospital of Ningbo University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etoposide, Cytarabine and Pegfilgrastim in people with Multiple Myeloma and Hematopoietic Stem Cell Mobilization, run by The Affiliated People's Hospital of Ningbo University at 16 sites 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 5 inclusion and 6 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 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ying Lu (+86-13486090834, 814871416@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of patients achieving the collection of ≥5×10^6 CD34+ cells/kg (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2024.