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RECRUITING

NCT07284758

PHASE2

A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Sponsor: C4 Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase 2, open-label, single-arm, multicenter study to assess the antimyeloma activity and further characterize the safety, tolerability, PK, and PD of cemsidomide in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (r/r MM).

Official title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-02-18

Completion Date

2030-03

Last Updated

2026-10-30

Healthy Volunteers

Conditions

Multiple Myeloma Relapsed/Refractory Multiple Myeloma

Interventions

DRUG

Cemsidomide

dosed orally (PO) once a day (QD) 14 days on/14 days off for each 28-day cycle

DRUG

Dexamethasone

dosed PO once a week (QW) on Days 1, 8, 15, and 22 for each 28-day cycle

Inclusion Criteria: 1. Be willing and able to provide signed informed consent for the study. 2. Age ≥ 18 years at the time of signed consent. 3. Subjects must have a documented diagnosis of MM and measurable disease at enrollment. 4. Received at least 3 prior anti-myeloma regimens (for a minimum of 2 or more consecutive cycles) that must have included an immunomodulatory drug (i.e., IKZF 1/3 degrader), a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager (TCE) or chimeric antigen receptor T-cell (CAR-T) therapy, unless not available per local standard of care. 5. Subjects need to have adequate organ function. 6. Toxicities from prior anticancer therapies must have resolved to baseline severity or CTCAE ≤ Grade 1. 7. Female subjects may not be pregnant or intend to become pregnant, may not breastfeed or intend to breastfeed, or donate ova during their participation in this study until 30 days after the last dose of study treatment. 8. Male subjects must agree to use a condom when having intercourse with a person of childbearing potential during the Treatment Period and for at least 30 days after the last dose of study treatment. 9. Male subjects must refrain from donating sperm during the Treatment Period and for 30 days after discontinuation. 10. Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation. Exclusion Criteria: 1. Presence of myeloma in the central nervous system (CNS). 2. Subjects with any of the following: * Systemic light chain amyloidosis * Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome * Myelodysplastic syndrome (MDS). 3. Previously treated with cemsidomide. 4. Clinically significant impaired cardiac function or cardiac disease. 5. Thromboembolic event within 3 months prior to enrollment. 6. Known malignancy other than study indication that has progressed or required treatment within the past 3 years. 7. Uncontrolled active bacterial, fungal, or viral infection. 8. Inability or difficulty swallowing tablets. NOTE: Other inclusion/exclusion criteria may apply, per protocol.

Locations (60)

Clearview Cancer Institute

Huntsville, Alabama, United States

Mayo Clinic - Arizona

Phoenix, Arizona, United States

HonorHealth

Scottsdale, Arizona, United States

City of Hope

Duarte, California, United States

Berenson Cancer Center

West Hollywood, California, United States

Mayo Clinic - Florida

Jacksonville, Florida, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Indiana University Health

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

START Midwest

Grand Rapids, Michigan, United States

Mayo Clinic - Minnesota

Rochester, Minnesota, United States

Washington University/Siteman Cancer Center

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

The Tisch Cancer Institute/Mount Sinai

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

UNC Hospitals Adult Oncology Clinics

Chapel Hill, North Carolina, United States

Tennessee Oncology

Nashville, Tennessee, United States

START San Antonio

San Antonio, Texas, United States

University of Wisconsin - Carbone Cancer Center

Madison, Wisconsin, United States

MCW-Clinical Cancer Center at Froedtert Hospital Campus

Milwaukee, Wisconsin, United States

Centre Hospitalier de la Côte Basque

Bayonne, France

Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

Lyon, France

Institut Paoli-Calmettes (IPC)

Marseille, France

Centre Henri-Becquerel

Rouen, France

Centre Hospitalier Universitaire (CHU) de Toulouse-Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)

Toulouse, France

Centre Hospitalier Regional et Universitaire de Tours (CHRU Tours) Hospital Bretonneau

Tours, France

Institut Gustave Roussy

Villejuif, France

Servizio Sanitario Regionale Emilia-Romagna-Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl

Meldola, Italy

Azienda Ospedaliera Universitaria (AOU) "Federico II"

Naples, Italy

Universita degli Studi di Pavia-Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Servizio Sanitario Regionale Emilia-Romagna - Ematologia Ospedale Infermi di Rimini

Rimini, Italy

Azienda Sanitaria Locale (ASL) Roma 1 - Ospedale Santo Spirito

Roma, Italy

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

IN-VIVO Sp.z.o.o

Bydgoszcz, Poland

Uniwersyteckie Centrum Kliniczne w Gdańsku

Gdansk, Poland

Pratia Hematologia Sp. Z o. o

Katowice, Poland

Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu

Wroclaw, Poland

Hospital Clínic de Barcelona

Barcelona, Spain

Institut Catala d'Oncologia (ICO) Badalona - Hospital Germans Trias i Pujol

Barcelona, Spain

Institut Català d'Oncologia (ICO) L'hospitalet

Barcelona, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Spain

Hospital Universitario de Cabueñes

Gijón, Spain

Complejo Asistencial Universitario de León

León, Spain

Hospital Universitario HM Sanchinarro

Madrid, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Complejo Asistencial Universitario De Salamanca (CAUSA)

Salamanca, Spain

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Imperial College Healthcare NHS Foundation Trust - Hammersmith Hospital

London, United Kingdom, United Kingdom

NHS Lothian - Western General Hospital- Edinburgh Cancer Centre

Edinburgh, United Kingdom

The Leeds Teaching Hospitals NHS Trust - St James's University Hospital

Leeds, United Kingdom

The King's College Hospital NHS Foundation Trust

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Newcastle University Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

GenesisCare, Beaumont House

Oxford, United Kingdom

GenesisCare, Windsor

Windsor, United Kingdom

Clinical Research Directory

A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (60)