Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01549431 | Study of the Combination of Panobinostat & Carfilzomib in Patients With Relapsed &/or Refractory Multiple Myeloma | PHASE1 | COMPLETED | 32 | — | — | Jan 1, 2012 | Apr 1, 2017 | Jan 16, 2019 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| Combo of Panobinostat and Carfilzomib | EXPERIMENTAL | A cycle of therapy is 4 weeks (28 days in duration). Carfilzomib (with dexamethasone during cycle 1) will be administered intravenously infusion on days 1, 2 and 8, 9 and 15, 16 of every 28 day cycle. Panobinostat is administered orally three times per week. |
| Name | Type | Description |
|---|---|---|
| Panobinostat | DRUG | Panobinostat will be supplied as 5-mg or 20-mg pink/opaque-colored, hard gelatin capsules. Panobinostat is administered orally three times per week. * Standard 3+3 design * 3 out of 4 weeks |
| Carfilzomib | DRUG | Carfilzomib in Cycle 1 will be initiated intravenously at 20 mg/m² on Days 1 and 2 and escalated to 27 mg/m² for Days 8, 9, 15, and 16 of Cycle 1 and for the duration of treatment. * Standard 3+3 design * Days 1/2, 8/9 and 15/16 every 4 weeks |
| Dexamethasone | DRUG | Dexamethasone (4 mg) must be given prior to each carfilzomib infusion during Cycle 1. Dexamethasone pre-dose should continue through Cycle 2 if fever is observed post-dose, Cycle 2 Day 1, or thereafter associated with the infusion of carfilzomib. |
Inclusion Criteria: 1. Male or female patients aged ≥ 18 years old 2. Diagnosis of multiple myeloma (MM) following at least one prior therapy; there is no maximum number or prior therapies 3. Patients must have relapsed/ refractory disease and be in need of therapy with evidence of measurable disea...