RecruitingPhase 1Phase 2NCT05583617

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

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

Sponsor

Hoffmann-La Roche

Enrollment

200 participants

Start Date

Nov 14, 2023

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a large platform study testing multiple different treatments in people with multiple myeloma — a cancer of plasma cells in the bone marrow. The study has several sub-studies (substudies), and your eligibility depends on which one you may join, based on your treatment history and disease status. **You may be eligible if...** - You have been diagnosed with multiple myeloma - You are in good enough health to participate (ECOG score 0–2) - Any side effects from previous cancer treatment have resolved - For one sub-study: you recently completed initial treatment, achieved a good response, and had a stem cell transplant within the last 100 days **You may NOT be eligible if...** - Your cancer is actively progressing - You have ongoing serious side effects from prior treatment - You do not meet the specific criteria for any open sub-study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCevostamab

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.

DRUGLenalidomide

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

DRUGTocilizumab

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

DRUGIberdomide

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

DRUGDexamethasone

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

View Full Details on ClinicalTrials.gov

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NCT05583617

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