Badanie skuteczności i bezpieczeństwa cevostamabu w połączeniu z pomalidomidem i deksametazonem u pacjentów z wcześniej leczonym szpiczakiem mnogim (1‑3 poprzednie terapie)

Enrollment and randomization

After signing the consent form, you are assigned a study number and the computer randomly places you into one of two treatment groups.

The assignment determines whether you receive the combination of cevostamab, pomalidomide and dexamethasone or the standard of care regimen.

Baseline assessments

Before the first dose, you undergo blood tests, a bone marrow aspirate, and other examinations to document the status of your disease.

The bone marrow sample is evaluated for minimal residual disease using next‑generation sequencing.

Initiation of study medication

Treatment starts on day 1 of cycle 1.

If you are in the experimental arm, you receive:

Cevostamab as an intravenous (IV infusion) given on the schedule defined by the protocol,

Pomalidomide as an oral tablet taken once daily on days 1‑21 of each 28‑day cycle,

Dexamethasone as an oral or IV dose taken on days specified in the protocol.

If you are assigned to the standard of care arm, you receive the drugs selected by the investigator, which may include elotuzumab (IV infusion), carfilzomib (IV infusion), or daratumumab (subcutaneous injection), each given according to the usual schedule for those medicines.

Regular treatment cycles

Each cycle lasts 28 days.

You continue to take the oral medication on the prescribed days and attend the clinic for the IV infusions on the days indicated in the protocol.

Dose adjustments, interruptions, or reductions may be made if side effects occur, following the study guidelines.

Clinical monitoring visits

During each cycle you visit the clinic for safety assessments, which include blood counts, chemistry panels, and evaluation of any adverse events.

The study team also records vital signs and asks about symptoms such as shortness of breath, cough, heart palpitations, rash, dizziness and nausea.

Disease evaluation

Every 3 months (or as defined in the protocol) you undergo imaging studies and a repeat bone marrow aspirate to assess response.

The primary efficacy outcomes are the minimal residual disease-Negative complete response rate at 9 months and progression‑free survival.

Treatment discontinuation and follow‑up

Treatment may be stopped after a predefined number of cycles, if disease progression is documented, or if unacceptable toxicity occurs.

After discontinuation you continue to be followed at scheduled intervals for survival status, long‑term safety, and quality‑of‑life assessments until the end of the study period.