A study of cemsidomide and dexamethasone in subjects with relapsed or refractory multiple myeloma (r/r MM)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

C4 Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15]

Decision date (initial)

2026-05-26

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

External identifiers

EU CT number

2025-524181-26-00

ClinicalTrials.gov

NCT07284758

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Efficacy, Pharmacokinetic, Safety

To determine antitumor activity of cemsidomide in combination with dexamethasone in subjects with r/r MM.

Secondary objectives 3

1. To evaluate additional antitumor activity of cemsidomide in combination with dexamethasone in subjects with r/r MM
2. To characterize the safety and tolerability of cemsidomide in subjects with r/r MM
3. To evaluate the PK of cemsidomide in subjects with r/r MM

Conditions and MedDRA coding

relapsed/refractory multiple myeloma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 1. Be willing and able to provide signed informed consent for the study.
2. 2. 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.
3. 3. Subjects must have a documented diagnosis of MM and measurable disease at enrollment.
4. 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. 5. Subjects need to have adequate organ function.
6. 6. Toxicities from prior anticancer therapies must have resolved to ≤ Grade 1.
7. 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. 8. Male subjects must refrain from donating sperm during the Treatment Period and for 30 days after discontinuation.
9. 9. Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation.

Exclusion criteria 8

1. 1. Presence of myeloma in the central nervous system (CNS).
2. 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. 3. Previously treated with cemsidomide.
4. 4. Clinically significant impaired cardiac function or cardiac disease.
5. 5. Thromboembolic event within 3 months prior to enrollment.
6. 6. Known malignancy other than study indication that has progressed or required treatment within the past 3 years.
7. 7. Any active uncontrolled bacterial, fungal or viral infection.
8. 8. Inability or difficulty swallowing tablets.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall response rate (ORR) per International Myeloma Working Group (IMWG) Response Criteria by an Independent Review Committee (IRC)

Secondary endpoints 7

1. Duration of response
2. Complete response (CR) rate
3. Time to response
4. Progression free survival
5. Overall survival
6. Frequency and severity of adverse events (AEs); serious AEs (SAEs); AEs leading to treatment interruption, reduction, or discontinuation; and deaths
7. Plasma concentrations of cemsidomide

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

C4 Therapeutics Inc.

Sponsor organisation

C4 Therapeutics Inc.

Address

490 Arsenal Way Suite 120

City

Watertown

Postcode

02472-2988

Country

United States

Scientific contact point

Organisation

C4 Therapeutics Inc.

Contact name

Study Medical Officer

Public contact point

Organisation

C4 Therapeutics Inc.

Contact name

Study Medical Officer

Third parties 6

Locations

4 EU/EEA countries · 27 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 35 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications