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Also known as Vorinostat, Lenalidomide, Carfilzomib, Dexamethasone
Vorinostat, Lenalinomide and Dexamethasone · 1 trial · 1 indication
Defined as: 1. Progression on therapy OR within 60 days after the last dose of a lenalidomide containing regimen OR 2. No clinical response (\<MR) on a lenalidomide containing regimen An overall response rate of 25% or more will be acceptable, while an overall response of less than or equal to 16% will be considered unacceptable. Response will be assessed according to a modified International Working Group Uniform Response Criteria (Durie et al., 2006) * Complete Response: Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and ⩽5% plasma cells in bone marrow * Very Good Partial Response- Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90 or greater reduction in serum M-component plus urine M-component \<100 mg per 24 h * Partial Response- ⩾50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ⩾90% or to \<200 mg per 24 h.
| Arm | Type | Description |
|---|---|---|
| Vorinostat, Lenalinomide, Dexamethasone | EXPERIMENTAL | Vorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21 \* Lenalidomide dose for patients with renal impairment (CrCL\<50ml/min) has be dose adjusted according to package insert Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above |
| Name | Type | Description |
|---|---|---|
| Vorinostat, Lenalinomide and Dexamethasone | DRUG | Vorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21 \* Lenalidomide dose for patients with renal impairment (CrCL\<50ml/min) has be dose adjusted according to package insert Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above |
Inclusion Criteria: * Subjects must meet all of the following inclusion criteria to be eligible to enroll in this study: * International Staging System symptomatic multiple myeloma, as recently defined (Kyle et al., 2009) or Durie-Salmon stage I-III multiple myeloma, after at least one (1) prior...
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Vorinostat, Lenalinomide and Dexamethasone is a combination of three drugs being studied for the treatment of multiple myeloma, a type of blood cancer. It is specifically being investigated in patients whose disease is refractory to previous lenalidomide-containing regimens. The combination is in Phase 1 clinical development.
Vorinostat, Lenalinomide and Dexamethasone is being developed by Meridian Bioscience Inc, a company traded on the stock exchange under the ticker symbol VIVO. The company is conducting clinical research on this combination for multiple myeloma.
Vorinostat, Lenalinomide and Dexamethasone is in Phase 1 clinical development. A Phase 1 trial has been completed, which enrolled 25 participants with multiple myeloma. The drug combination is investigational and has not been approved by regulatory authorities.
Vorinostat, Lenalinomide and Dexamethasone has one completed clinical trial registered under NCT01502085. The trial was a Phase 1 study in the United States that enrolled 25 adults with multiple myeloma refractory to previous lenalidomide-containing regimens. The study was not randomized or blinded.
Vorinostat, Lenalinomide and Dexamethasone is also known as Vorinostat, Lenalidomide, Carfilzomib and Dexamethasone. These names refer to the same drug combination being studied for multiple myeloma. The combination includes vorinostat, lenalidomide, and dexamethasone, with carfilzomib as an additional component in the alternative name.