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| Name | Class |
|---|---|
| Jiangsu Hengrui Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 2 | Experimental |
| |
| lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 5 | Experimental |
| |
| myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 2 | Experimental |
| |
| myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 5 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoposide | Drug | Etoposide 1.5-1.8g/m2, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of successful mobilization | The percentage of subjects with ≥2×106 cell/kg CD34+ cells were collected. | up to 28 days since the last subject were given mecapegfilgrastim |
| Measure | Description | Time Frame |
|---|---|---|
| the number of the total CD34+ cells | the number of the total CD34+ cells which were collected from each subject | up to 28 days since the last subject were given mecapegfilgrastim |
| the number of leukaphereses |
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Inclusion Criteria:
Exclusion Criteria:
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:
Patients who have received any of the following treatments:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Liu | Contact | 86-022-23909282 | liuwei@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Not yet recruiting | Hefei | Anhui | China |
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| Cyclophosphamide | Drug | Cyclophosphamide 50mg/kg or 2g/m2, for 2 days |
|
| Mecapegfilgrastim, day 2 | Drug | Mecapegfilgrastim 12mg SC, on day 2 after chemotherapy |
|
| Mecapegfilgrastim, day 5 | Drug | Mecapegfilgrastim 12mg SC, on day 5 after chemotherapy |
|
the number of leukaphereses needed to collect ≥2×10^6/kg CD34+ cells
| up to 28 days since the last subject were given mecapegfilgrastim |
| Incidence of febrile neutropenia (FN) | incidence of FN during chemotherapy plus mecapegfilgrastim mobilization | 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 | up to 1 year post-transplantation |
| Peking University Third Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
|
| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | China |
|
| Shandong Cancer Hospital | Not yet recruiting | Jinan | Shandong | China |
|
| Institute of Hematology & Blood Diseases Hospital | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
|
| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
|
| Tianjin Medical University General Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | China |
|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008223 | Lymphoma |
| 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 |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| D003520 | Cyclophosphamide |
| C423652 | pegylated 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 |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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