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The purpose of this study is to compare the efficacy of cyclophosphamide plus dexamethasone combined with rituximab or bortezomib regimens in newly diagnosed Waldenström macroglobulinemia patients.
Newly diagnosed WM patients will be randomly assigned to BCD or RCD group for introduction chemotherapy. Chemotherapeutic response will be evaluated after 3 cycles. If a PR or better response achieves, addition 3 cycles will be given. If not, patients will be crossed to control group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patients will quit this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bortezomib | Experimental | Patients in this group will receive bortezomib+ cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. Chemotherapeutic response will be evaluated after 3 cycles. If a MR or better response achieves, addition 3 cycles will be given. If not, patients will cross to RCD group for another 3 cycles. If a MR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study. |
|
| rituximab | Experimental | Patients in this group will receive rituximab+cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. Chemotherapeutic response will be evaluated after 3 cycles. If a MR or better response achieves, addition 3 cycles will be given. If not, patients will cross to BCD group for another 3 cycles. If a MR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia |
|
| Measure | Description | Time Frame |
|---|---|---|
| progress-free survival | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shuhua Yi, Doc | Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shuhua Yi | Tianjin | 300020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38205507 | Derived | Xiong W, Lyu R, Yu Y, Wang T, Yan Y, Wang Y, Liu W, An G, Deng S, Xu Y, Sui W, Huang W, Zou D, Wang J, Qiu L, Yi S. Rituximab plus cyclophosphamide and dexamethasone versus bortezomib plus cyclophosphamide and dexamethasone in newly diagnosed symptomatic Waldenstrom macroglobulinemia: a randomized controlled trial. Haematologica. 2024 May 1;109(5):1614-1618. doi: 10.3324/haematol.2023.284588. No abstract available. |
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we will make the data publicly available according to the local law
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| ID | Term |
|---|---|
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| Rituximab | Drug | compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia |
|
|
| 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 |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |