Cemsidomide + Dexamethasone for Multiple Myeloma

(MOMENTUM Trial)

Overseen By Study Medical Officer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: C4 Therapeutics, Inc.

Disqualifiers: CNS myeloma, Amyloidosis, POEMS, MDS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 28-day cycles

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of two drugs, cemsidomide and dexamethasone, in treating multiple myeloma, a type of blood cancer. Researchers aim to determine if this combination benefits individuals whose cancer has returned or stopped responding to other treatments. Participants must have tried at least three different treatments for multiple myeloma, including specific therapies. The study will also assess the safety and tolerability of the treatment for participants. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that cemsidomide and dexamethasone are likely to be safe for humans?

Research shows that the combination of cemsidomide and dexamethasone is generally well-tolerated. In earlier studies, this treatment showed promising results for people with multiple myeloma, a type of blood cancer. At higher doses, 40% to 53% of patients responded positively, experiencing benefits.

These studies examined both the treatment's effectiveness and its safety. Although specific side effects aren't detailed, the progression to further trials indicates it is considered safe enough for continued testing. Participants in these studies have not reported major safety concerns that would halt further research, suggesting that the treatment is tolerated by patients with multiple myeloma. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple myeloma?

Cemsidomide is unique because it offers a novel approach to treating multiple myeloma by targeting a different mechanism than most existing therapies. While standard treatments like bortezomib, lenalidomide, and thalidomide primarily work by disrupting cancer cell growth, Cemsidomide is believed to engage a specific pathway that enhances the body's immune response against cancer cells. Researchers are excited about Cemsidomide because it could potentially lead to better outcomes for patients who have not responded well to other treatments, providing a new line of attack against this challenging disease.

What evidence suggests that cemsidomide and dexamethasone might be an effective treatment for multiple myeloma?

Research has shown that combining cemsidomide with dexamethasone may help treat relapsed or hard-to-treat multiple myeloma. In earlier studies, this combination reduced cancer signs in more than half of the participants when administered at higher doses. Cemsidomide has also performed well in lab tests, suggesting its potential effectiveness before use in humans. In this trial, participants will receive the combination of cemsidomide and dexamethasone, as researchers are actively studying its potential benefits for those with this challenging condition. ^{1 2 3 4 5}

Who Is on the Research Team?

Aurore Perrot, M.D.

Principal Investigator

Universite de Toulouse

Binod Dhakal, M.D.

Principal Investigator

Medical College of Wisconsin

Martin Kaiser, M.D.

Principal Investigator

The Royal Marsden

Are You a Good Fit for This Trial?

This trial is for adults over 18 with relapsed/refractory multiple myeloma who have tried at least three prior treatments, including specific drugs. Participants must not be pregnant or planning pregnancy, willing to use contraception, and have good organ function. Excluded are those with myeloma in the CNS, certain other conditions like amyloidosis or MDS, previous cemsidomide treatment, significant heart issues, uncontrolled infections, swallowing difficulties or recent thromboembolic events.

Inclusion Criteria

I will not donate blood during the study.

Be willing and able to provide signed informed consent for the study

My organs are functioning well.

Exclusion Criteria

My myeloma has spread to my brain or spinal cord.

I have been diagnosed with systemic light chain amyloidosis, POEMS Syndrome, or Myelodysplastic syndrome (MDS).

I have been treated with cemsidomide before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cemsidomide plus dexamethasone during a 28-day treatment cycle, continuing until discontinuation criteria are met

28-day cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cemsidomide
• Dexamethasone

Trial Overview

The study tests Cemsidomide combined with Dexamethasone's effectiveness and safety in treating multiple myeloma that hasn't responded to other treatments. It's a Phase 2 trial where all participants receive the same combination therapy to evaluate its impact on their cancer and overall health.

How Is the Trial Designed?

Group I: Cemsidomide + Dexamethasone: Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

C4 Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

480+

Citations

1.

c4therapeutics.gcs-web.com

c4therapeutics.gcs-web.com/news-releases/news-release-details/c4-therapeutics-presents-cemsidomide-phase-1-multiple-myeloma

C4 Therapeutics Presents Cemsidomide Phase 1 Multiple ...

Cemsidomide in Combination With Dexamethasone Achieved a 50% Overall Response Rate (ORR) at the Highest Dose Level (100 µg) and a 40% ORR at ...

2.

ir.c4therapeutics.com

ir.c4therapeutics.com/news-releases/news-release-details/c4-therapeutics-reports-third-quarter-2025-financial-results-and

C4 Therapeutics Reports Third Quarter 2025 Financial ...

In the Phase 1 trial, cemsidomide in combination with dexamethasone achieved a 40% and 53% overall response rate at the two highest dose levels, 75 µg and 100 ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07284758?term=NA

A Study to Evaluate the Efficacy of Cemsidomide + ...

A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/​Refractory Multiple Myeloma (MOMENTUM).

4.

ashpublications.org

ashpublications.org/blood/article/144/Supplement%201/3366/532707/Initial-Results-of-a-Phase-1-First-in-Human-Study

Initial Results of a Phase 1 First-in-Human Study of ...

Cemsidomide has demonstrated best-in-class activity in multiple myeloma (MM) preclinical models and has also been shown to stimulate immune ...

5.

ir.c4therapeutics.com

ir.c4therapeutics.com/static-files/39670c4f-0806-41b6-8813-ef7adcf04207

Updated Results of a Phase 1 First-in-Human Study of

Best Response: Multiple Myeloma – Cemsidomide 14/14 + Dex*. • ORR (≥ PR) of ... • Cemsidomide is well suited for further development across multiple lines of ...