NIPH Clinical Trials Search

CEVOSTAMAB IN COMBINATION WITH POMALIDOMIDE AND DEXAMETHASONE VERSUS STANDARD OF CARE IN PATIENTS WITH PREVIOUSLY TREATED MULTIPLE MYELOMA

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	2-4 Line Relapse / Refractory Multiple Myeloma
Date of first enrollment	15/07/2026
Target sample size	380
Countries of recruitment	south Korea,Japan,China,Japan,Israel,Japan,United States,Japan,Canada,Japan,Brazil,Japan,Czech Republic,Japan,Denmark,Japan,Germany,Japan,Greece,Japan,Poland,Japan,Spain,Japan,United Kingdom,Japan,France,Japan,Italy,Japan,Australia,Japan
Study type	Interventional
Intervention(s)	RO7187797:Cevostamab will be administered intravenously on a 21-day cycle in cycle 1 and on a 28-day cycle from cycle 2 onwards. pomalidomide:Participants will receive pomalidomide capsule orally PO as per the schedule given in the protocol. Dexamethasone:Participants will receive dexamethasone orally PO or IV as per the schedule given in the protocol. Daratumumab (Genetical Recombination), Vorhyaluronidase Alfa (Genetical Recombination):Participants will receive daratumumab SC as per the schedule given in the protocol. Elotuzumab (Genetical Recombination):Participants will receive elotuzumab IV as per the schedule given in the protocol. Carfilzomib:Participants will receive carfilzomib IV as per the schedule given in the protocol.

Outcome(s)

Primary Outcome

- Efficacy -- MRD negative CR rate -- PFS

Secondary Outcome

- Efficacy -- VGPR or better rate, ORR, CR rate, TTR, TTBR, DOR, Overall MRD-negative CR rate, Overall MRD-negative rate and Sustained MRD-negative CR rate -- OS - Safety -- Incidence and severity of adverse events: NCI CTCAE v5.0, ASTCT Consensus Grading and NCI PRO-CTCAE, FACTG GP5 -- Tolerability: The incidence of dose interruptions, dose reductions, dose intensity, and treatment discontinuation - Other -- QOL: EORTC QLQ-MY20 and EORTC QLQ-C30 -- Immunogenicity: ADA against cevostamab

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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
Exclude criteria	- 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