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RECRUITING
NCT05583617
PHASE1/PHASE2

A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations, as monotherapy or in combination, in participants with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available. Information regarding the opened substudies are found below.

Official title: A Platform Study Evaluating the Safety and Efficacy of Multiple Treatments in Patients With Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2023-11-14

Completion Date

2028-07-31

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DRUG

Cevostamab

Substudy 2: Cevostamab will be administered intravenously (IV) on a 28-day cycle, up to a total of 13 cycles. Substudy 4: Cevostamab will be administered by IV on a 21-day cycle, up to a total of 17 cycles.

DRUG

Lenalidomide

Lenalidomide will be administered PO on days 1-21 of a 28-day cycle.

DRUG

Tocilizumab

Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.

DRUG

Iberdomide

Iberdomide will be administered PO on days 1-14 of a 21-day cycle.

DRUG

Dexamethasone

Dexamethasone will be administered on Days 2 and 8 of Cycles 1-3.

Locations (16)

Prince of Wales Hospital

Randwick, New South Wales, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

CHU Lyon Sud - Service Hématologie

Pierre-Bénite, France

IUCT Oncopole

Toulouse, France

Hopital Bretonneau

Tours, France

IGR

Villejuif, France

Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

Hamburg, Germany

Universitätsklinikum Leipzig - Klinik und Poliklinik für Hämatologie

Leipzig, Germany

Uniwersyteckie Centrum Kliniczne

Gda?sk, Poland

Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

Olsztyn, Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Późna, Poland

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Fundacion Jimenez Diaz

Madrid, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain