臨床研究等提出・公開システム

A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CEVOSTAMAB IN COMBINATION WITH POMALIDOMIDE

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

Tina Nielsen

F. Hoffmann-La Roche Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU,Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU,Tokyo

+81-120189706

clinical-trials@chugai-pharm.co.jp

Recruiting

July. 15, 2026

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- 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

- 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

Both

2-4 Line Relapse / Refractory Multiple Myeloma

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.

- Efficacy
-- MRD negative CR rate
-- PFS

- 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

+81-532-33-6111

Mar. 19, 2026

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

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