Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label clinical study to evaluate the efficacy and safety of a multicenter, open-label clinical study of a base-reduced-dose pomalidomide, cyclophosphamide combined with dexamethasone (PCd) regimen for the treatment of patients with debilitating relapsed refractory multiple myeloma.
Subjects meeting the enrollment criteria were screened for entry into the study and treated with the appropriate regimen; all patients enrolled in the study did not receive medications other than those specified in the regimen for the treatment of myeloma during the study period, except for supportive care. The primary endpoint of the study is ORR; secondary study endpoints include efficacy above VGPR, progression-free survival (PFS), overall survival (OS), TTNT, safety, and life scale assessment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced-dose pomalidomide/cyclophosphamide/dexamethasone (PCd) regimen group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomalidomide, cyclophosphamide combined with dexametha | Drug | The starting dose of pomalidomide was 2 mg in all cases,the starting dose of cyclophosphamide was 50 mg/day.If the adverse event is attributable to a specific study drug, the dose is reduced accordingly for that drug; if the adverse event is associated with multiple drugs, the dose is reduced appropriately for one of the predominantly associated drugs at the discretion of the investigator; and if multiple adverse events occur concurrently, the dose should be adjusted according to the guidelines for the most severe toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Overall Response Rate | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy above VGPR | Stringent complete response is defined as fulfilling the criteria for CR combined with a normal serum free light chain ratio and the absence of clonal plasma cells in the bone marrow as confirmed by immunohistochemistry. CR is negative serum and urine immunofixation electrophoresis, disappearance of soft tissue plasmacytomas, and <5% plasma cells in the bone marrow. Very good partial response (VPR) is a serum protein electrophoresis with no detectable M protein, but serum and urine immunofixation electrophoresis are still positive; or a reduction in M protein of ≥90% and urinary M protein <100mg/24h. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weiwei Tian, Doctor | Contact | +8613485304136 | 408933582@qq.com | |
| Jie Zhao, Master | Contact | +8618734895885 | 429809209@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaomin Zhang | Shanxi Bethune Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ShanxiBethuneH | Recruiting | Taiyuan | Shanxi | 030032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| up 3 years |
| PFS | progression-free survival (within 2 years) | within 2 years |
| OS | overall survival | up to 2 years |
| duration from start of study treatment with all 3 agents to start of any new line of treatment | up to 3 years |
| safety of drugs | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 and EORTC QLQ-C30. | up to 2 years |
| life scale assessment above VGPR(very good partial response) | EORTC QLQ-C30 (1-3 months/dose) | up to 3 years |
| ID | Term |
|---|---|
| C467566 | pomalidomide |
Not provided
Not provided
Not provided