Conversion to Carfilzomib Therapy in Bortezomib Intolerant Newly Diagnosed Multiple Myelom
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.
| Condition(s) | Newly Diagnosed Multiple Myeloma |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. ≥ 18 years of age 2. Diagnosed with multiple myeloma according to IMWG criteria. 3. Patients who have received only first-line bortezomib-based triple therapy, including bortezomib/lenalidomide/dexamethasone (VRD), bortezomib/thalidomide/dexamethasone (VTD）,bortezomib/ cyclophosphamide/dexamethasone (VCD), and bortezomib/adriamycin//dexamethasone (PAD). 4. Eastern cooperative oncology group(ECOG) score 0-2 5. 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 and resulting in bortezomib dose reduction or discontinuation. 6. Patients who agree |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | The First Affiliated Hospital of Soochow University |
| Locations | Suzhou, Jiangsu, China |
| Start date | 2024-09-10 |
| NCT ID | NCT06682156 |
| Official listing | https://clinicaltrials.gov/study/NCT06682156 |