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| Name | Class |
|---|---|
| First Affiliated Hospital of Zhejiang University | OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoposide | Drug | Day 1~Day 2: 75mg/m^2 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| % 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 | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| % 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. | 1 month |
| CD34+ cells and the average number of collections |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Lu | Contact | +86-13486090834 | 814871416@qq.com | |
| Peipei Ye | Contact | +86-13685832706 | 39612903@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Lu | The Affiliated People's Hospital of Ningbo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongyang People's Hospital | Recruiting | Dongyang | Zhejiang | China |
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| The Central Hospital of Lishui City | OTHER |
| Jinhua People's Hospital | OTHER |
| Shaoxing People's Hospital | OTHER |
| Shaoxing Second Hospital | OTHER |
| Zhejiang Provincial Tongde Hospital | OTHER |
| Taizhou Hospital | OTHER |
| Dongyang People's Hospital | OTHER |
| Affiliated Hospital of Jiaxing University | OTHER |
| Huizhou Municipal Central Hospital | OTHER |
| Second Affiliated Hospital of Wenzhou Medical University | OTHER |
| Ningbo Medical Center Lihuili Hospital | OTHER_GOV |
| Jinhua Municipal Central Hospital | OTHER |
Prospective, randomized, two-arm, multicenter, exploratory study
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| Cytarabine | Drug | Day 1~Day 2: 200g/m^2, q12h |
|
|
| Pegfilgrastim | Drug | Day 6: 6mg |
|
|
| Cyclophosphamide | Drug | Day 1~Day 2: 1～2g/m^2 |
|
|
| G-CSF | Drug | Subcutaneous injection at dose 5ug/kg, from day 6 until the end of mobilization. |
|
|
| G-CSF | Drug | 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. |
|
|
Comparison of the total amount of CD34+ cells collected and the average number of collections between the EAP and CG regimens. |
| 1 month |
| Adverse Rvents (AEs) | Comparison of hematological and non-hematological adverse reactions between the EAP and CG regimens. | 1 month |
| % of patients who use Plerixafor | Comparison of the proportion of patients who add Plerixafor between the EAP and CG regimens. | 1 month |
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | China |
|
| Tongde Hospital of Zhejiang Province | Recruiting | Hangzhou | Zhejiang | China |
|
| Huzhou central hospital | Recruiting | Huzhou | Zhejiang | China |
|
| The First Hospital of Jiaxing | Recruiting | Jiaxing | Zhejiang | China |
|
| Jinhua Municipal Central Hospital | Recruiting | Jinhua | Zhejiang | China |
|
| Jinhua People's Hospital | Recruiting | Jinhua | Zhejiang | China |
|
| Lishui Central Hospital | Recruiting | Lishui | Zhejiang | China |
|
| Ningbo Medical Center Lihuili Hospital | Recruiting | Ningbo | Zhejiang | China |
|
| The Affiliated People's Hospital of Ningbo University | Recruiting | Ningbo | Zhejiang | China |
|
| Shaoxing People's Hospital | Recruiting | Shaoxing | Zhejiang | China |
|
| Shaoxing Second Hospital | Recruiting | Shaoxing | Zhejiang | China |
|
| Taizhou Central Hospital | Recruiting | Taizhou | Zhejiang | China |
|
| Taizhou Hospital of Zhejiang Province | Recruiting | Taizhou | Zhejiang | China |
|
| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | China |
|
| The Second Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | China |
|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| D003561 | Cytarabine |
| C455861 | pegfilgrastim |
| C423652 | pegylated granulocyte colony-stimulating factor |
| D003520 | Cyclophosphamide |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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