Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SKCD · 1 trial · 1 indication
The proportion of participants who achieve a confirmed complete response (CR) or stringent complete response (sCR), according to the International Myeloma Working Group criteria, during the first nine cycles of SKCD treatment and before initiation of Kd maintenance therapy.
| Arm | Type | Description |
|---|---|---|
| SKCD：Sonrotoclax+Carfilzomib+Aponermin+Dexamethasone | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SKCD | DRUG | Eligible patients will receive the SKCD regimen for up to 9 cycles (28 days per cycle). Patients who do not develop disease progression or meet withdrawal criteria proceed to Kd maintenance therapy: * Cycle 1 (C1, 28-day cycle): Sonrotoclax: Oral dose ramp-up / escalated to 320 mg QD, PO, Days 1-28; Carfilzomib: 20 mg/m² IV on Days 1 and 2, then 27 mg/m² IV on Days 8, 9, 15, and 16; Aponermin (CPT): 10 mg/kg IV on Days 1-5; Dexamethasone: 20 mg PO or IV on Days 1, 2, 8, 9, 15, 16, 22, and 23. * Cycles 2 to 9 (C2-C9, 28-day cycles): Sonrotoclax: 320 mg QD, PO, Days 1-28; Carfilzomib: 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16; Aponermin (CPT): 10 mg/kg IV on Days 1-5; Dexamethasone: 20 mg PO or IV on Days 1, 2, 8, 9, 15, 16, 22, and 23. * Post-Cycle 9 Kd Maintenance Phase (28-day cycles): Carfilzomib: 27 mg/m² IV on Days 1, 2, 15, and 16; Dexamethasone: 10 mg PO or IV on Days 1, 2, 15, and 16. |
Inclusion Criteria Candidates must satisfy all of the following inclusion criteria to be enrolled in the study: * 1\. Age: Age \> 18 years, male or female. * 2\. Measurable Disease: Diagnosed with multiple myeloma according to the 2014 IMWG diagnostic criteria, with measurable disease at screening...
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