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The purpose of this study is to evaluate the efficacy and safety of permadomide capsules developed by Qilu Pharmaceutical Co., LTD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Permadomide + Low-Dose Dexamethasone | Experimental | Participants received 4 mg pomalidomide administered by mouth on Days 1 to 21 of each 28-day treatment cycle and 40 mg dexamethasone administered by mouth once per day on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomalidomide | Drug | 4 mg pomalidomide capsules administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Response Rate(ORR) | Statistical analysis of ORR of primary efficacy will be based on IRC remission assessment results, as well as the investigator's remission assessment.Strict Complete Response (sCR) + Complete Response (CR) + Partial Response (PR) + Very Good PR (VGPR). | From randomization through the study follow-up phase; up to the data cut-off of 1 December 2023; Maximum time on follow-up was 104 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of remission(DoR) | The time from the first observation of at least partial remission (PR) to disease progression (PD) or death from any cause is whichever comes first. | The time from the first observation of at least partial remission (PR) to disease progression (PD) or death from any cause is whichever comes first, assessed up to 104 weeks. |
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Inclusion Criteria:
1.Subjects diagnosed with multiple myeloma according to the diagnostic criteria of Chinese Multiple Myeloma Diagnosis and Treatment Guidelines (Revised in 2020); 2.Must be ≥ 18 years of age,male or female, if the subject is of childbearing age and should use effective contraceptive methods, the subject must agree to comply with all contraceptive requirements:
3. Received at least two previous treatments (in different treatment regimens or the same regimen, including at least 2 cycles of lenalidomide and 2 cycles of proteasome inhibitors [such as bortezomib or ixazomib]) Relapse of multiple myeloma or ineffective to the last treatment (definition of last treatment ineffective: disease progression during the use of the treatment plan or disease progression within 60 days after the completion of the treatment plan), the last treatment plan is not limited; 4. Multiple myeloma subjects with measurable M protein, i.e., at least one of the following 3 assays:
1) ANC≥1.0 x10^9/L (including ANC≥1.0x10^9/L supported by G-CSF); 2) PLT≥50 x10^9/L; 3) When plasma cells in bone marrow ≥50%, no specific requirements for neutrophil count, platelet ≥30 x10^9/L can be selected; 6. Liver and kidney function tests meet the following conditions:
Exclusion Criteria:
1) According to the NYHA classification standard, cardiac insufficiency grade 2 or above; 2) Myocardial infarction occurred within one year; 3) poorly controlled angina pectoris, including variant angina pectoris; 11. Subjects have serious infectious diseases at the same time; 12. Subjects planning to become pregnant or unable to take reliable contraceptive measures; 13. Women who are pregnant or breastfeeding; 14. Subjects who have received allogeneic hematopoietic stem cell transplantation within 12 months, or who have active graft-versus-host disease (GVHD) or who require immunosuppressive therapy after 12 months of allogeneic hematopoietic stem cell transplantation; 15. Those who participated in other clinical trials and received experimental drugs within one month before the first drug use.
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| Name | Affiliation | Role |
|---|---|---|
| Wenming Chen, MD, PhD | Beijing Chao Yang Hospital | Principal Investigator |
| Juan Li, MD, PhD | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Hongmei Jing, MD, PhD | Peking University Third Hospital | Principal Investigator |
| Huo Tan, MD, PhD | The First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Shunqing Wang, MD, PhD | Guangzhou First People's Hospital | Principal Investigator |
| Ying Zhao, MD, PhD | First People's Hospital of Foshan | Principal Investigator |
| Xun Lai, MD, PhD | Yunnan Cancer Hospital | Principal Investigator |
| Qing Wang, MD, PhD | Guizhou Provincial People's Hospital | Principal Investigator |
| Jinqiao Zhang, MD, PhD | Hebei Medical University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital, Capital Medical University | Beijing | Beijing Municipality | 100000 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38112795 | Derived | Zhou H, Wang Y, Chen J, He A, Jin J, Lu Q, Zhao Y, Li J, Hou M, Su L, Lai X, Wang W, Liu L, Ma Y, Gao D, Lai W, Zhou X, Jing H, Zhang J, Yang W, Ran X, Lin C, Hao J, Xiao T, Huang Z, Zhu Z, Wang Q, Fang B, Wang B, Song Y, Cai Z, Liu B, Zhu Y, Yang X, Kang X, Li J, Chen W. Efficacy and safety of generic pomalidomide plus low-dose dexamethasone in relapsed or refractory multiple myeloma: a multicenter, open-label, single-arm trial. Ann Hematol. 2024 Mar;103(3):855-868. doi: 10.1007/s00277-023-05558-y. Epub 2023 Dec 19. |
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| Dexamethasone |
| Drug |
40 mg dexamethasone tablets administered orally |
|
| Progression-free survival(PFS) | The time between the first dose of this trial and the onset of progression (evaluated according to IMWG efficacy criteria listed in the China Guidelines for the Diagnosis and Treatment of Multiple Myeloma 2020 (see attachment)) or death. | up to 104 weeks |
| Overall survival(OS) | The time between enrollment for the first dose of the study and the death of the patient from any cause (the last follow-up date for the lost subjects and the end date for the patients who were still alive at the end of the study). | up to 104 weeks |
| Lihong Liu, MD, PhD | Hebei Medical University Fourth Hospital | Principal Investigator |
| Baijun Fang, MD, PhD | Henan Tumor Hospital | Principal Investigator |
| Junjun Li, MD, PhD | The First Affiliated Hospital of Nanhua University | Principal Investigator |
| Binghua Wang, MD, PhD | Weihai Central Hospital | Principal Investigator |
| Wei Yang, MD, PhD | Shengjing Hospital | Principal Investigator |
| Wei Wang, MD, PhD | The Affiliated Hospital of Qingdao University | Principal Investigator |
| Ming Hou, MD, PhD | Shandong University Qilu Hospital | Principal Investigator |
| Aili He, MD, PhD | Second Affiliated Hospital of Xi 'an Jiaotong University | Principal Investigator |
| Yafei Wang, MD, PhD | Tianjin Cancer Hospital | Principal Investigator |
| Jie Jin, MD, PhD | The First Affiliated Hospital of Zhejiang University Medical College (Hematology) | Principal Investigator |
| Xuehong Ran, MD, PhD | Weifang People's Hospital | Principal Investigator |
| Jiao Chen, MD, PhD | Sichuan Provincial People's Hospital | Principal Investigator |
| Liping Su, MD, PhD | Shanxi Province Cancer Hospital | Principal Investigator |
| Yanping Ma, MD, PhD | Second Hospital of Shanxi Medical University | Principal Investigator |
| Yanping Song, MD, PhD | Xi 'an Central Hospital | Principal Investigator |
| Congmeng Lin, MD, PhD | Zhangzhou Hospital, Fujian Province | Principal Investigator |
| Quanyi Lu, MD, PhD | Zhongshan Hospital Xiamen University | Principal Investigator |
| Da Gao, MD, PhD | The Affiliated Hospital of Inner Mongolia Medical University | Principal Investigator |
| Wenhong Lai, MD, PhD | The First Affiliated Hospital of Gannan Medical College | Principal Investigator |
| Jianping Hao, MD, PhD | First Affiliated Hospital of Xinjiang Medical University | Principal Investigator |
| Taiwu Xiao, MD, PhD | Liaocheng People's Hospital | Principal Investigator |
| Zhen Cai, MD, PhD | The First Affiliated Hospital of Zhejiang University Medical College (Transplant Center) | Principal Investigator |
| Xin Zhou, MD, PhD | Wuxi People's Hospital | Principal Investigator |
| Peking University Third Hospital |
| Beijing |
| Beijing Municipality |
| 100000 |
| China |
| Shengjing Hospital affiliated to China Medical University | Beijing | Beijing Municipality | 100000 | China |
| Foshan First People's Hospital | Foshan | Guangdong | 528000 | China |
| Guangzhou First People's Hospital | Guangzhou | Guangdong | 510000 | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510000 | China |
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| Guizhou Provincial People's Hospital | Guiyang | Guizhou | 550000 | China |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
| The Third Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
| Henan Tumor Hospital | Zhengzhou | Henan | 450000 | China |
| The First Affiliated Hospital of Nanhua University | Hengyang | Hunan | 421200 | China |
| Shandong University Qilu Hospital | Jinan | Shandong | 250000 | China |
| Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
| Weifang People's Hospital | Weifang | Shandong | 261000 | China |
| Weihai Central Hospital | Weihai | Shandong | 264200 | China |
| Shanxi Cancer Hospital | Taiyuan | Shanxi | 030000 | China |
| The Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |
| Second Affiliated Hospital of Xi 'an Jiaotong University | Xi’an | Shanxi | 710000 | China |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610000 | China |
| Tianjin Cancer Hospital | Tianjin | Tianjin Municipality | 300000 | China |
| Yunnan Cancer Hospital | Kunming | Yunnan | 650000 | China |
| The First Affiliated Hospital of Zhejiang University Medical College (Hematology) | Hangzhou | Zhejiang | 310000 | China |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C467566 | pomalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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