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This is an open-label, single-arm study to evaluate the safety and efficacy of bortezomib plus dexamethasone for acquired pure red cell aplasia failure or relapse after first-line treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bortezomib/dexamethasone | Experimental | Enrolled patients will receive the combination therapy of bortezomib and dexamethasone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bortezomib/dexamethasone | Drug | Enrolled patients would receive the combination therapy of bortezomib and dexamethasone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | within 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of adverse events and severe adverse events | within 12 weeks | |
| Relapse free survival | within 24 and 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Shi, PhD | Institute of Hematology & Blood Diseases Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhoukou Central Hospital | Zhoukou | Henan | China | |||
| The Second Affilated Hospital of Shandong First Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33957358 | Background | Zhang L, Chen N, Xu Z, Liang Q, Pan H, Zhao J, Fang L, Shi J. Good treatment-free survival of monoclonal gammopathy of undetermined significance associated pure red cell aplasia after bortezomib plus dexamethasone. Blood Cells Mol Dis. 2021 Jul;89:102573. doi: 10.1016/j.bcmd.2021.102573. Epub 2021 Apr 27. |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| Tai’an |
| Shandong |
| China |
| Regenerative Medicine Center | Tianjin | China |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |