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| Name | Class |
|---|---|
| Peking University People's Hospital | OTHER |
| Shanghai Changzheng Hospital | OTHER |
| Shanghai 6th People's Hospital | OTHER |
| Peking University Shenzhen Hospital |
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This is a multicenter, randomized controlled, open-label study, and the purpose of this study is to compare the efficiency and safety of PVD regimen (Pomalidomide & Bortezomib & Dexamethasone) versus VD regimen (Bortezomib & Dexamethasone) in NDMM patients with RI. The main efficacy indicator is VGPR after 4 cycles of induction therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pomalidomide, Bortezomib and Dexamethasone (PVD) | Experimental | Each cycle is 21 days, after 2 cycles, patients who reached MR continued treatment for 2 cycles, 4 cycles in total. Subsequent treatment regimens after 4 cycles of induction therapy were determined by the investigator. |
|
| Bortezomib and Dexamethasone (VD) | Active Comparator | Each cycle is 21 days, after 2 cycles, patients who reached MR continued treatment for 2 cycles, 4 cycles in total. Subsequent treatment regimens after 4 cycles of induction therapy were determined by the investigator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pomalidomide | Drug | Pomalidomide was administered orally at a dose of 4 mg on days 1-14 of each cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ≥very good partial response | The sum of a complete response and a very good partial response | At end of cycle 4 (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| MRD negative rate | When patients reached CR, NGF was used to detect the proportion of patients with bone marrow clonoplasma cells without phenotypic abnormalities. The minimum detection sensitivity was 1 clonoplasma cell in 10000 nucleated cells | From randomization to the date of first documented evidence of PD until study completion, an average of 1.5 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Hou, PhD | Contact | 02168383144 | houjian@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jian Hou, PhD | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
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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 |
|---|---|
| C467566 | pomalidomide |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| OTHER |
| The Third People's Hospital of Chengdu | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Ningbo No. 1 Hospital | OTHER |
| The First Affiliated Hospital of Nanchang University | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
2(PVD):1(VD) random inclusion
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| Bortezomib | Drug | Bortezomib was administered intravenously or subcutaneously at a dose of 1.3mg/m2 on days 1, 4, 8, 11 of each cycle. |
|
| Dexamethasone | Drug | Dexamethasone was administered orally at a dose of 20mg on days the same and next day of bortezomib administration. |
|
| immunologic function | Twelve cytokine assays, lymphocyte subsets and absolute count, Treg cell assays, lymphocyte activation marker assays, TH1/TH2/TH17 subsets of cytokines assays | At day 1±3 of cycle 2-5 (each cycle is 21 days) |
| renal tubular function | Renal remission rate was evaluated according to the 2016 IMWG expert consensus on MM renal injury | At day 1±3 of cycle 2-5 (each cycle is 21 days) |
| safety(Number of adverse events ) | Number of adverse events according to symptoms, physical examination and scheduled laboratory tests | Each cycle (each cycle is 21 days), up to 24 months of follow-up |
| 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 |
| 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 |