In short
Cemsidomide is an investigational medicine being studied in a Phase 2 clinical trial for people with relapsed or refractory multiple myeloma, a cancer of plasma cells. The trial, NCT07284758, is authorised and plans to enrol 98 participants. It tests cemsidomide given by mouth together with dexamethasone, and its main measure is the overall response rate.
Key points
- Cemsidomide is being studied in a Phase 2 trial for relapsed or refractory multiple myeloma.
- The trial is authorised and plans to enrol 98 participants.
- Cemsidomide is given orally at a dose of 100 micrograms.
- It is studied in combination with dexamethasone.
- The primary outcome is overall response rate (ORR) assessed by an independent review committee.
- The trial identifier is NCT07284758.
What is cemsidomide?
Cemsidomide is an investigational substance being studied for the treatment of relapsed or refractory multiple myeloma. Multiple myeloma is a cancer of plasma cells, a type of white blood cell found in the bone marrow. The term relapsed or refractory means the disease has either come back after previous treatment or has not responded to earlier therapies. In the trial registry, cemsidomide is recorded as a chemically synthesised substance, and it has no marketing authorisation in these records, meaning it is still under investigation.
How does cemsidomide work?
The trial record does not describe the mechanism of action of cemsidomide. What is known from the registry is that the trial combines cemsidomide with dexamethasone, a corticosteroid medicine commonly used in multiple myeloma treatment to reduce inflammation and kill myeloma cells. The purpose stated in the trial record is to determine the antitumor activity of cemsidomide in this combination.
Which conditions is cemsidomide studied for?
- Relapsed or refractory multiple myeloma — a form of blood cancer in which plasma cells grow out of control, and which has returned after or resisted previous treatment.
How is cemsidomide given?
In the registered trial, cemsidomide is given orally, at a dose of 100 micrograms. The trial record lists this as the intervention for the cemsidomide arm.
What do the clinical trials show?
There is one registered clinical trial of cemsidomide in the data, identified as NCT07284758. It is a Phase 2, interventional study in relapsed or refractory multiple myeloma. The trial is authorised, meaning it has received regulatory approval to proceed. It plans to enrol 98 participants.
The primary outcome is the overall response rate (ORR), which measures the proportion of participants whose cancer shrinks or disappears after treatment. In this trial, the ORR is assessed according to the International Myeloma Working Group (IMWG) Response Criteria by an Independent Review Committee (IRC), meaning an external group of experts evaluates the responses to make the assessment objective.
Participants in this trial have relapsed or refractory multiple myeloma, meaning their disease has come back after or not responded to previous treatment. The trial studies cemsidomide in combination with dexamethasone. No results have been reported yet, as the trial is only authorised and not yet completed.
What side effects are known?
The registry record for this trial does not list side effects. Because cemsidomide is still investigational, its safety profile is being evaluated in the ongoing trial.