Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mezigdomide · 4 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| MeziKd (Mezigdomide + Carfilzomib + Dexamethasone) | EXPERIMENTAL | - |
| Kd (Carfilzomib + Dexamethasone) | ACTIVE_COMPARATOR | - |
| MeziVd (mezigdomide, bortezomib and dexamethasone) | EXPERIMENTAL | - |
| PVd (pomalidomide, bortezomib and dexamethasone) | EXPERIMENTAL | - |
| Group A: Participants with severe renal impairment | EXPERIMENTAL | - |
| Group B: Participants with End Stage Renal Disease | EXPERIMENTAL | - |
| Group C: Participants with normal renal function | EXPERIMENTAL | - |
| Mild hepatic impairment | EXPERIMENTAL | - |
| Moderate hepatic impairment | EXPERIMENTAL | - |
| Severe hepatic impairment | EXPERIMENTAL | - |
| Healthy participants | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Mezigdomide | DRUG | Specified dose on specified days |
| Carfilzomib | DRUG | Specified dose on specified days |
| Dexamethasone | DRUG | Specified dose on specified days |
| Pomalidomide | DRUG | Specified dose on specified days |
| Bortezomib | DRUG | Specified dose on specified days |
Inclusion Criteria \- Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following:. i) Myeloma-protein (M-protein) ≥ 0.5 grams/deciliter (g/dL) by serum protein electrophoresis (sPEP), or. ii) M-protein ≥ 200 milligrams (mg)/24-hour urine colle...
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Mezigdomide is an investigational small molecule being studied for relapsed or refractory multiple myeloma, hepatic impairment, and renal impairment. It is being evaluated in combination regimens for multiple myeloma and in pharmacokinetic studies for organ impairment. Mezigdomide is not approved and remains in clinical development.
Mezigdomide is a cereblon-modulating agent, belonging to the -domide class of drugs. It works by binding to cereblon, a component of the E3 ubiquitin ligase complex, which leads to the degradation of target proteins. This mechanism is being studied for its anti-myeloma activity.
Mezigdomide is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug in multiple myeloma and in patients with hepatic or renal impairment.
Mezigdomide is in Phase 1 clinical development for hepatic and renal impairment studies, while two Phase 3 trials are evaluating it in relapsed or refractory multiple myeloma. The Phase 3 trials are recruiting or active but not recruiting. Mezigdomide is investigational and not FDA approved.
Mezigdomide is being studied in four clinical trials. NCT05519085 and NCT05552976 are Phase 3 trials in relapsed or refractory multiple myeloma, testing mezigdomide with bortezomib and dexamethasone or with carfilzomib and dexamethasone. NCT05707390 and NCT06318676 are completed Phase 1 studies in hepatic and renal impairment.
Mezigdomide is also known by the investigational code CC-92480. It is a cereblon-modulating agent developed by Bristol-Myers Squibb. The drug is being evaluated under the name mezigdomide in clinical trials for multiple myeloma and organ impairment studies.