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Business Decision
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The primary objective of this study is to document efficacy and safety data in a real-world setting of Chinese multiple myeloma patients who have received at least one prior therapy treated with REVLIMID (lenalidomide).
This registry is prospective, multi-center, observational study and will collect efficacy and safety data on multiple myeloma adult patients who have received at least one prior therapy and take REVLIMID as part of standard care associated with patients' treatment in order to characterize the use, efficacy and outcomes of REVLIMID treatment.
The registry will capture data from 600 patients being prescribed REVLIMID in specified hospitals and all patients will be followed in the registry for two years after enrollment of the last patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple Myeloma Patients Treated with Revlimid (lenalidomide) | Single Cohort of Multiple Myeloma Patients Treated with Revlimid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revlimid (lenalidomide) | Drug | Revlimid (lenalidomide) as prescribed in usual clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Assessment of PFS using IMWG Uniform Response Criteria | 2 years after enrollment of last patient |
| Response Rates | Assessment of Response Rates (CR, VGPR, PR) using IMWG Uniform Response Criteria | 2 years after enrollment of last patient |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Two years after last patient enrolled | |
| Time to Response (TTR) and Duration of Response (DOR) | Two years after last patient enrolled | |
| Duration of Treatment with Revlimid |
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Inclusion Criteria:
Exclusion Criteria:
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Adult Chinese Patients with Multiple Myeloma Treated with Revlimid (Lenalidomide) in a Postmarketing setting
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| Name | Affiliation | Role |
|---|---|---|
| Yu (Flora) Yao, MD | Celgene Pharmaceutical (Shanghai) Co. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Chao-Yang Hospital | Beijing | 100020 | China | |||
| Peking University People's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28693058 | Derived | Wang GM, Yang GZ, Huang ZX, Zhong YP, Jin FY, Liao AJ, Wang XM, Fu ZZ, Liu H, Li XL, Zhou JF, Zhang X, Hu Y, Meng FY, Huang XJ, Chen WM, Lu J. [A prospective multi-center trial of non-interventional and observational study of lenalidomide in Chinese patients with multiple myeloma]. Zhonghua Nei Ke Za Zhi. 2017 Jul 1;56(7):500-506. doi: 10.3760/cma.j.issn.0578-1426.2017.07.006. Chinese. |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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Reason for dose interruption/reduction of REVLIMID, if this occurs. Reason for discontinuation of REVLMID |
| Two years after last patient enrolled. |
| Safety Profile of Revlimid | All Adverse Events (AEs) and occurrence of second primary malignancies (SPM) | Two years after last patient enrolled |
| Beijing |
| 100044 |
| China |
| People's Liberation Army Hospital 307 | Beijing | 100071 | China |
| Beijing Hospital | Beijing | 100730 | China |
| The Fisrt Hospital Of Jilin University | Changchun | 130031 | China |
| Xiangya Hospital Central-South University | Changsha | 410008 | China |
| Xinqiao Hospital, 3rd Military Medical University | Chongqing | 410008 | China |
| NanFang Hospital of China Southern Medical University | Guangzhou | 510515 | China |
| The First Affliated Hospital of Anhui Medical University | Hefei | 230032 | China |
| Qilu Hospital of Shandong University | Jinan | 250012 | China |
| The Affiliated Hospital of Mecical College Qingdao University | Qingdao | 266003 | China |
| Shanghai Changzhen Hospital | Shanghai | 200003 | China |
| The Second Affiliated Hospital Of China Medical University | Shenyang | 110004 | China |
| The First Affiliated Hospital of Suzhou University | Suzhou | 215006 | China |
| People's Hospital of Xinjiang Uygur Autonomous Region | Ürümqi | 830001 | China |
| Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science & Technology | Wuhan | 430000 | China |
| Tongji Medical College Huazhong University of Science & Technology | Wuhan | 430030 | China |
| 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 |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |