Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pomalidomide · 2 trials · 2 indications
Completed response (CR) rates will be determined for CPd maintenance.
Overall response was defined as the best overall confirmed response of: Complete response (CR): Negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in bone marrow (BM). Stringent CR (sCR): CR and normal serum free light chain ratio and no clonal cells in BM. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-h). PR: ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to \< 200 mg/24-h. Assessment was by IRC per International Myeloma Working Group Uniform Response Criteria (IMWG-URC). The 90% confidence intervals were estimated using the Clopper-Pearson method (1994).
| Arm | Type | Description |
|---|---|---|
| Carfilzomib, pomalidomide, dexamethasone | EXPERIMENTAL | Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15, pomalidomide PO daily on days 1-21, and dexamethasone PO daily on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Carfilzomib combined with pomalidomide and dexamethasone | EXPERIMENTAL | Carfilzomib, pomalidomide, and dexamethasone (KPd) |
| Name | Type | Description |
|---|---|---|
| Carfilzomib | DRUG | Given IV |
| Dexamethasone | DRUG | Given PO |
| Pomalidomide | DRUG | Given PO |
Inclusion Criteria: * Patients must meet the following criteria on screening examination to be eligible to participate in the study; all laboratory assessments should be performed within 28 days of initiation of protocol therapy unless otherwise specified; subject is, in the investigator's opinion,...
Pomalidomide is a small molecule being studied for the treatment of Relapsed or Refractory Multiple Myeloma and Plasma Cell Myeloma. It is currently in Phase 2 clinical development and is considered investigational, meaning it has not been approved for these indications. The drug is being evaluated in combination with other agents in clinical trials.
Pomalidomide targets cereblon, a protein that is part of the -domide class of drugs. By binding to cereblon, it modulates the ubiquitin-proteasome pathway, which can lead to the degradation of specific proteins involved in cancer cell growth. This mechanism is being studied in the context of multiple myeloma.
Pomalidomide is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen is conducting clinical trials to evaluate the drug's safety and efficacy in patients with multiple myeloma.
Pomalidomide is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing and completed trials are designed to assess its effectiveness and safety in patients with multiple myeloma.
Pomalidomide is being studied in two Phase 2 trials. NCT03756896 is an active, not recruiting study of Carfilzomib, Pomalidomide, and Dexamethasone in high-risk multiple myeloma with 29 participants in the United States. NCT04191616 is a completed study of early relapsed, lenalidomide-refractory subjects eligible for Carfilzomib triplet, with 54 participants across multiple countries.
Pomalidomide belongs to the -domide class of drugs, which includes other cereblon modulators. However, it is a distinct compound with its own chemical structure and properties. It is being studied specifically for its potential in treating multiple myeloma, and its development is separate from other drugs in the same class.