Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ACY-1215 · 2 trials · 1 indication
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...
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ACY-1215 is an investigational small molecule being studied for the treatment of multiple myeloma. It has been evaluated in Phase 1 clinical trials, both alone and in combination with other agents, in patients with this blood cancer. The drug is not yet approved and remains in clinical development.
ACY-1215 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company has sponsored clinical trials of the drug in multiple myeloma.
ACY-1215 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total enrollment of 158 patients. The drug is investigational and has not been approved by regulatory authorities.
ACY-1215 has been studied in two completed Phase 1 trials. NCT01323751 evaluated the drug alone and with bortezomib and dexamethasone in 120 patients with multiple myeloma. NCT01583283 tested it with lenalidomide and dexamethasone in 38 patients. Both trials were conducted in the United States.
ACY-1215 is also known as ricolinostat. It is a small molecule being studied in multiple myeloma. The drug has been tested in combination with standard myeloma therapies in Phase 1 clinical trials.