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

ConditionMultiple Myeloma

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorHoffmann-La Roche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy or documented within serum amyloid P component scan)

Plasma cell leukemia or circulating plasma cell count exceeding 500 cells/liter (L) or 5% of the peripheral blood white cells

GI disease that might significantly alter absorption of oral drugs

Participants must not have any ongoing CNS disease or non-secretory myeloma

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

380 Participants

are divided into 2 treatment groups

Group A: Cevostamab + Pomalidomide + DexamethasoneExperimental treatment 3 interventions

Group B: Standard of Care (SOC)Active comparator 5 interventions

Trial outcomes

Primary outcomes

Minimal Residual Disease (MRD)-Negative Complete Response (CR) Rate

Time frame

Up to 1 year after the last participant is randomized

Progression-Free Survival (PFS)

Time frame