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
Not provided
Not provided
This is an open-label, single-arm, prospective study conducted in real-world clinical practice. It aims to evaluate the efficacy and safety in Chinese patients with newly diagnosed multiple myeloma who switch to carfilzomib-based regimens after bortezomib-based triple-drug regimen intolerance happens.
This is an open-label, single-arm, prospective study conducted in real-world clinical practice. Chinese patients with newly diagnosed multiple myeloma will be enrolled if they switch to carfilzomib-based regimens after bortezomib-based triple-drug regimen intolerance happens.
Induction and consolidation therapy will be 6-8cycles. 6 cycles for transplant recipients and 8 cycles for non-transplant recipients. Maintenance therapy will continue until progression.
It aims to evaluate the efficacy and safety of carfilzomib based therapy in Chinese NDMM patients with intolerance to bortezomib. The primary endpoint is the rate of 2-year pFS and secondary endpoints are the rate of ORR,sCR/CR,VGPR,PR, the rate and duration of MRD, the rate of 2-year OS and safety.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K-based therapy | if bortezomib related intolerance happens during front line therapy of bortezomib-based triple regimen, then carfilzomib-based therapy will be used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carfilzomib | Drug | carfilzomib C1: 20mg/m2,D1-2; 27mg/m2,D8-9; 36mg/m2,D15-16 C2 and subsequent cycles: 36mg/m2。 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Outcome of peripheral neuropathy | recurrence of peripheral neuropathy | from enrollment to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | the rate of sCR,CR, PR and VGPR according to IMWG(International Myeloma Working Group) criteria | from enrollment to 2 years |
| sCR/CR rate | the rate of sCR/CR according to IMWG criteria |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Newly diagnosed multiple myeloma patients who develop toxicities associated with bortezomib therapy evaluated by the investigator, including the presence of Grade 1 with pain or Grade 2 peripheral neuropathy (PN), Grade 3 hepatic impairment, Grade 3 diarrhea, and any other Grade 3 non-hematologic adverse events
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lingzhi Yan | Recruiting | Suzhou | Jiangsu | 215006 | China |
Not provided
| ID | Term |
|---|---|
| C524865 | carfilzomib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| from enrollment to 2 years |
| PR rate | the rate of PR according to IMWG criteria | from enrollment to 2 years |
| VGPR rate | the rate of VGPR according to IMWG criteria | from enrollment to 2 years |
| MRD negativity rate | the rate of minimal residual disease | from enrollment to 2 years |
| AE rate | the rate of adverse events | from enrollment to 2 years |
| 2-year OS rate | the rate of Overall survival at 2 years | from enrollment to 2 years |
| Duration of MRD negativity | Duration of minimal residual disease negativity | from enrollment to 2 years |
| 2-year PFS rate | the rate of progression free survival at 2 years | from enrollment to 2 years |