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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01583283 | Study of ACY-1215 in Combination With Lenalidomide, and Dexamethasone in Multiple Myeloma | PHASE1 | COMPLETED | 38 | — | — | Jul 12, 2012 | Mar 24, 2021 | Feb 23, 2022 | 5 | United States |
| NCT01323751 | Study of ACY-1215 Alone and in Combination With Bortezomib and Dexamethasone in Multiple Myeloma | PHASE1 | COMPLETED | 120 | — | — | Jul 1, 2011 | Dec 3, 2016 | Apr 6, 2017 | 6 | United States |
Number of participants with Dose Limiting Toxicity (DLT)
Maximum Tolerated Dose is defined as the dose level immediately below the DLT dose level.
The objective response rate is the proportion of subjects achieving an investigator conformed partial response (PR) or better, to treatment according to IMWG (International Myeloma Working Group).
| Arm | Type | Description |
|---|---|---|
| ACY-1215, Lenalidomide and Dexamethasone | EXPERIMENTAL | Open label dosing cohorts will evaluate oral ACY-1215 (doses ranging from 40 - 480 mg days 1-5, 8-12, 15-19) in combination with oral Lenalidomide (doses ranging from 15 - 25 mg days 1-21) and oral Dexamethasone (40 mg once weekly). |
| Treat Regimen | EXPERIMENTAL | ACY-1215 Bortezomib Dexamethasone |
| Name | Type | Description |
|---|---|---|
| ACY-1215 | DRUG | Dose escalation up to 480 mg administered orally on Days 1-5, 8-12 and 15-19 of a 28 day dosing schedule. |
| lenalidomide | DRUG | Dosed on Days 1-21 of a 28 day cycle. |
| Dexamethasone | DRUG | Dosed on Days 1, 8, 15 and 22 of a 28 day treatment cycle. |
Inclusion Criteria: * Relapsed or Relapsed/Refractory MM with progressive disease (PD) according to IMWG. * Received at least 1 prior line of therapy for MM (Phase 1) * Secretory MM for which the patient previously received 1-3 prior lines of therapy (Phase 2). * Able to provide written consent * N...