RecruitingNCT07555938ClinicalTrials.gov record

Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma

Multiple Myeloma

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 3
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 380 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) versus standard of care (SOC) in participants with multiple myeloma (MM) who have received one to three prior lines of therapy and have been exposed to an anti-CD38 monoclonal antibody (mAb) and lenalidomide.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening and immediately prior to start of administration of study treatment.
Individuals with ECOG Performance Status of 2 solely due to local symptoms of myeloma (e.g., pain) are eligible
MM diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria
Received one to three lines of prior therapy that included at least two consecutive cycles of either of the following: A regimen containing an anti-CD38 therapy, a regimen containing lenalidomide
Participants must have measurable disease during screening

Exclusion Criteria:

Known history of systemic light chain amyloidosis with major organ involvement (e.g., positive Congo Red stain or equivalent in tissue biopsy or documented within serum amyloid P component scan)
Known history or current plasma cell leukemia
GI disease that might significantly alter absorption of oral drugs
Participants must not have any ongoing CNS disease or non-secretory myeloma

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: No masking

Cevostamab + Pomalidomide + Dexamethasone

Cevostamab will be administered intravenously on a 21-day cycle in cycle 1 and on a 28-day cycle from cycle 2 onwards.

Pomalidomide will be administered orally (PO) on a 28-day cycle from cycle 2 onwards.

Dexamethasone will be administered as a premedication prior to cevostamab.

Drug: Cevostamab · Drug: Pomalidomide · Drug: Dexamethasone

Standard of Care (SOC)

Participants will receive investigator's choice of one SOC regimen.

Drug: Pomalidomide · Drug: Dexamethasone · Drug: Daratumumab · Drug: Elotuzumab · Drug: Carfilzomib

Cevostamab DRUG

Participants will receive cevostamab IV as per the schedule given in the protocol.

Pomalidomide DRUG

Participants will receive pomalidomide tablet orally PO as per the schedule given in the protocol.

Dexamethasone DRUG

Participants will receive dexamethasone tablet orally PO or IV as per the schedule given in the protocol.

Daratumumab DRUG

Participants will receive daratumumab SC as per the schedule given in the protocol.

Elotuzumab DRUG

Participants will receive elotuzumab IV as per the schedule given in the protocol.

Carfilzomib DRUG

Participants will receive carfilzomib IV as per the schedule given in the protocol.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.