Multiple MyelomaPhase 2MOMENTUMNCT07284758
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
A Phase 2 study testing Cemsidomide and Dexamethasone in people with Multiple Myeloma and Relapsed/Refractory Multiple Myeloma, run by C4 Therapeutics, Inc. at 60 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
- What is being tested?
- Cemsidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 60 sitesin 6 countries
- Study dates
- 18 Feb 2026to Mar 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing and able to provide signed informed consent for the study.
- Age ≥ 18 years at the time of signed consent.
- Subjects must have a documented diagnosis of MM and measurable disease at enrollment.
- 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.
- Subjects need to have adequate organ function.
- Toxicities from prior anticancer therapies must have resolved to baseline severity or CTCAE ≤ Grade 1.
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- 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.
- 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.
- Male subjects must refrain from donating sperm during the Treatment Period and for 30 days after discontinuation.
- Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation.
Who cannot join
- Presence of myeloma in the central nervous system (CNS).
- Subjects with any of the following:
- Systemic light chain amyloidosis
- Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome
- Myelodysplastic syndrome (MDS).
- Previously treated with cemsidomide.
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- Clinically significant impaired cardiac function or cardiac disease.
- Thromboembolic event within 3 months prior to enrollment.
- Known malignancy other than study indication that has progressed or required treatment within the past 3 years.
- Uncontrolled active bacterial, fungal, or viral infection.
- Inability or difficulty swallowing tablets.
- NOTE: Other inclusion/exclusion criteria may apply, per protocol.
Trial locations and contacts
60 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
60 sites in 6 countries
United States25 sites, 25 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Matthew Piakno, MD
- Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Nisha Joseph, MD
- Not yet recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02114
Jessica Ligel, MD
- Not yet recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02114
Paul Richardson, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Andrew Yee, MD
- Recruiting
UNC Hospitals Adult Oncology Clinics
Chapel Hill, North Carolina, 27514
Sascha Tuchman, MD
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Craig Cole, MD
- Recruiting
City of Hope
Duarte, California, 91010
Michael Rosenzweig, MD
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
Andrew Sochacki, MD
- Recruiting
Clearview Cancer Institute
Huntsville, Alabama, 35805
Lakshmikanth Katragadda, MD
- Recruiting
Indiana University Health
Indianapolis, Indiana, 46202
Attaya Suvannasankha, MD
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Christopher Strouse, MD
- Recruiting
Mayo Clinic - Florida
Jacksonville, Florida, 32224
Sikander Ailawadhi, MD
- Recruiting
University of Wisconsin - Carbone Cancer Center
Madison, Wisconsin, 53792
Natalie Callander, MD
- Recruiting
MCW-Clinical Cancer Center at Froedtert Hospital Campus
Milwaukee, Wisconsin, 53226
Binod Dhakal, MD
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
Jesus Berdeja, MD
- Recruiting
The Tisch Cancer Institute/Mount Sinai
New York, New York, 10029
Shambavi Richard, MD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Hamza Hashmi, MD
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Sarah Holstein, MD
- Recruiting
Mayo Clinic - Arizona
Phoenix, Arizona, 85054
Saurabh Chhabra, MD
- Recruiting
Mayo Clinic - Minnesota
Rochester, Minnesota, 55905
Wilson Gonsalves, MD
- Recruiting
START San Antonio
San Antonio, Texas, 78229
Kyriakos Papadopoulos, MD
- Recruiting
HonorHealth
Scottsdale, Arizona, 85258
Rizwan Khawaja, MD
- Recruiting
Washington University/Siteman Cancer Center
St Louis, Missouri, 63108
Mark Schroeder, MD
- Recruiting
Berenson Cancer Center
West Hollywood, California, 90069
James Berenson, MD
Spain9 sites, 9 recruiting
- Not yet recruiting
Hospital Clínic de Barcelona
Barcelona
Laura Rosiñol Dachs, MD
- Not yet recruiting
Institut Catala d'Oncologia (ICO) Badalona - Hospital Germans Trias i Pujol
Barcelona
Gladys Ibarra Fernández, MD
- Not yet recruiting
Institut Català d'Oncologia (ICO) L'hospitalet
Barcelona
Itziar Carro Arostegui, MD
- Not yet recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar
Valentin Cabañas Perianes, MD
- Not yet recruiting
Hospital Universitario de Cabueñes
Gijón
Maria Esther Gonzalez Garcia, MD
- Not yet recruiting
Complejo Asistencial Universitario de León
León
Fernando Escalante-Barrigón, MD
- Not yet recruiting
Hospital Universitario HM Sanchinarro
Madrid
Luis Felipe Casado Montero, MD
- Not yet recruiting
Clinica Universidad de Navarra
Pamplona
Paula Rodríguez Otero, MD
- Not yet recruiting
Complejo Asistencial Universitario De Salamanca (CAUSA)
Salamanca
Maria Victoria Mateos Manteca, MD
United Kingdom9 sites, 9 recruiting
- Recruiting
NHS Lothian - Western General Hospital- Edinburgh Cancer Centre
Edinburgh
Victoria Campbell, MD
- Recruiting
The Leeds Teaching Hospitals NHS Trust - St James's University Hospital
Leeds
Christopher Parrish, MD
- Recruiting
Imperial College Healthcare NHS Foundation Trust - Hammersmith Hospital
London, United Kingdom
Aristeidis Chaidos, MD
- Recruiting
The King's College Hospital NHS Foundation Trust
London
Kirsty Cuthill, MD
- Recruiting
The Christie NHS Foundation Trust
Manchester
Emma Searle, MD
- Recruiting
Newcastle University Hospitals NHS Foundation Trust
Newcastle upon Tyne
Andrew Charlton, MD
- Not yet recruiting
GenesisCare, Beaumont House
Oxford
Karthik Ramasamy, MD
- Recruiting
The Royal Marsden NHS Foundation Trust
Sutton, Surrey
Martin Kaiser, MD
- Not yet recruiting
GenesisCare, Windsor
Windsor
Jaimal Kothari, MD
France7 sites, 7 recruiting
- Recruiting
Centre Hospitalier de la Côte Basque
Bayonne
Julie Gay, MD
- Not yet recruiting
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Lyon
Lionel Karlin, MD
- Not yet recruiting
Institut Paoli-Calmettes (IPC)
Marseille
Jean-Marc Schiano de Colella, MD
- Not yet recruiting
Centre Henri-Becquerel
Rouen
Pascal Lenain, MD
- Not yet recruiting
Centre Hospitalier Universitaire (CHU) de Toulouse-Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)
Toulouse
Aurore Perrot, MD
- Not yet recruiting
Centre Hospitalier Regional et Universitaire de Tours (CHRU Tours) Hospital Bretonneau
Tours
Thomas Chalopin, MD
- Not yet recruiting
Institut Gustave Roussy
Villejuif
Vincent Ribrag, MD
Italy6 sites, 6 recruiting
- Not yet recruiting
Servizio Sanitario Regionale Emilia-Romagna-Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl
Meldola
Claudio Cerchione, MD
- Not yet recruiting
Azienda Ospedaliera Universitaria (AOU) "Federico II"
Naples
Fabrizio Pane, MD
- Not yet recruiting
Universita degli Studi di Pavia-Fondazione IRCCS Policlinico San Matteo
Pavia
Silvia Mangiacavalli, MD
- Not yet recruiting
Servizio Sanitario Regionale Emilia-Romagna - Ematologia Ospedale Infermi di Rimini
Rimini
Francesco Rotondo, MD
- Not yet recruiting
Azienda Sanitaria Locale (ASL) Roma 1 - Ospedale Santo Spirito
Roma
Tommaso Caravita di Toritto, MD
- Recruiting
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
Angelo Michele Carella, MD
Poland4 sites, 4 recruiting
- Not yet recruiting
IN-VIVO Sp.z.o.o
Bydgoszcz
Jaroslaw Czyz, MD
- Not yet recruiting
Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk
Agata Tyczynska, MD
- Recruiting
Pratia Hematologia Sp. Z o. o
Katowice
Sebastian Grosicki, MD
- Not yet recruiting
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Wroclaw
Tomasz Wrobel, MD
About this study
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
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).
- Being tested
- Cemsidomide, Dexamethasone
- Keywords
- cemsidomide, dexamethasone, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemsidomideDrug
dosed orally (PO) once a day (QD) 14 days on/14 days off for each 28-day cycle
DexamethasoneDrug
dosed PO once a week (QW) on Days 1, 8, 15, and 22 for each 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Cemsidomide + Dexamethasone: | Experimental | Participants receive cemsidomide plus dexamethasone during a 28-day treatment cycle, and will continue to receive treatment until the participant meets one of the discontinuation criteria. Receives: Drug: Cemsidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR) per International Myeloma Working Group (IMWG) Response Criteria by an Independent Review Committee (IRC)
Measured: up to approximately 43 months
Secondary outcomes (7)
Duration of response (DoR; IRC assessed)
Measured: up to approximately 43 months
Complete response (CR) rate (IRC assessed)
Measured: up to approximately 43 months
Time to response (IRC assessed)
Measured: up to approximately 43 months
Progression free survival (PFS; IRC assessed)
Measured: up to approximately 43 months
Overall survival (OS)
Measured: up to approximately 43 months
Adverse events (AEs); serious AEs (SAEs); AEs leading to treatment interruption, reduction, or discontinuation; and deaths
Measured: within 30 to 35 days of the last dose of study treatment
Plasma concentrations of cemsidomide
Measured: up to approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start18 Feb 2026
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- C4 Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Binod Dhakal, M.D., Principal investigator, Medical College of WisconsinMartin Kaiser, M.D., Principal investigator, The Royal MarsdenAurore Perrot, M.D., Principal investigator, Universite de Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284758
- Sponsor's protocol ID
- CFT7455-2101
- Acronym
- MOMENTUM
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07284758
- Acronym / sponsor ID
- MOMENTUM / CFT7455-2101
- Keywords
- cemsidomide, dexamethasone, Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- C4 Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cemsidomide + Dexamethasone: | Experimental | Drug: Cemsidomide, Drug: DexamethasoneParticipants receive cemsidomide plus dexamethasone during a 28-day treatment cycle, and will continue to receive treatment until the participant meets one of the discontinuation criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be willing and able to provide signed informed consent for the study.
- Age ≥ 18 years at the time of signed consent.
- Subjects must have a documented diagnosis of MM and measurable disease at enrollment.
- 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.
- Subjects need to have adequate organ function.
Key exclusion criteria (12 listed)
- Presence of myeloma in the central nervous system (CNS).
- Subjects with any of the following:
- Previously treated with cemsidomide.
- Clinically significant impaired cardiac function or cardiac disease.
- Thromboembolic event within 3 months prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cemsidomidedosed orally (PO) once a day (QD) 14 days on/14 days off for each 28-day cycle | Drug | Cemsidomide + Dexamethasone: |
| Dexamethasonedosed PO once a week (QW) on Days 1, 8, 15, and 22 for each 28-day cycle | Drug | Cemsidomide + Dexamethasone: |
Primary outcome
Overall response rate (ORR) per International Myeloma Working Group (IMWG) Response Criteria by an Independent Review Committee (IRC)
Time frame: up to approximately 43 months
7 secondary outcomes
Duration of response (DoR; IRC assessed)
Time frame: up to approximately 43 months
Complete response (CR) rate (IRC assessed)
Time frame: up to approximately 43 months
Time to response (IRC assessed)
Time frame: up to approximately 43 months
Progression free survival (PFS; IRC assessed)
Time frame: up to approximately 43 months
Overall survival (OS)
Time frame: up to approximately 43 months
Adverse events (AEs); serious AEs (SAEs); AEs leading to treatment interruption, reduction, or discontinuation; and deaths
Time frame: within 30 to 35 days of the last dose of study treatment
Plasma concentrations of cemsidomide
Time frame: up to approximately 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Binod Dhakal, M.D. principal investigator
Medical College of Wisconsin
Martin Kaiser, M.D. principal investigator
The Royal Marsden
Aurore Perrot, M.D. principal investigator
Universite de Toulouse
60 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cemsidomide and Dexamethasone in people with Multiple Myeloma and Relapsed/Refractory Multiple Myeloma, run by C4 Therapeutics, Inc. at 60 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Spain, United Kingdom, France, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Medical Officer ((617) 231-0700, clinicaltrials@c4therapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) per International Myeloma Working Group (IMWG) Response Criteria by an Independent Review Committee (IRC) (time frame: up to approximately 43 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.