Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
POM+ DEX · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 4 mg Oral POM + 40 mg Oral DEX | EXPERIMENTAL | Oral POM at 4 mg on days 1-21 of a 28-day cycle, Oral DEX at 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on days 1, 8, 15 and 22 of a 28-day cycle |
| 2 mg Oral POM + 40 mg Oral DEX | EXPERIMENTAL | Oral POM at 2 mg on days 1-21 of a 28-day cycle, Oral DEX at 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on days 1, 8, 15 and 22 of a 28-day cycle |
| Name | Type | Description |
|---|---|---|
| 4 mg Oral POM + 40 mg Oral DEX | DRUG | - |
| 2 mg Oral POM + 40 mg Oral DEX | DRUG | - |
Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Must be ≥ 18 years at the time of signing the informed consent form 2. Must understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures 3. Must be abl...
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POM+ DEX is a combination treatment pairing pomalidomide with dexamethasone. It was studied in multiple myeloma, a cancer of plasma cells in the bone marrow. The regimen was evaluated in a Phase 1 trial that enrolled 25 patients with multiple myeloma and impaired renal function.
POM+ DEX was studied for treating multiple myeloma, including in patients who also had impaired renal function. The single trial, NCT01575925, evaluated the pharmacokinetics and safety of pomalidomide in that patient population. It is an investigational combination and is not described as approved for this use.
POM+ DEX is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company sponsored the Phase 1 trial NCT01575925, titled Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function.
POM+ DEX is in Phase 1 development. Its only listed trial, NCT01575925, is a completed Phase 1 study with 25 enrolled patients. The study was controlled but not randomized and not double blinded, and it enrolled adults aged 18 years and older.
POM+ DEX has been studied in one clinical trial, NCT01575925, also called the POM Renal study. It evaluated pomalidomide pharmacokinetics and safety in patients with multiple myeloma and impaired renal function. The trial is completed, enrolled 25 patients, and took place in the United States and Canada.