Multiple Myeloma (MM)Phase 1NCT07280013
A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
A Phase 1 study testing Cemsidomide and Elranatamab in people with Multiple Myeloma (MM), run by C4 Therapeutics, Inc. at 19 sites in United States.
Trial summary
The main purpose of the study is to understand the safety and tolerability of cemsidomide when given along with elranatamab in subjects with relapsed or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM)
- What is being tested?
- Cemsidomide and Elranatamab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 19 sitesUnited States
- Study dates
- 6 Feb 2026to Jun 2029
- Phase
- Phase 1
- 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
- Diagnosis of multiple myeloma as defined by IMWG criteria
- Measurable disease based on IMWG criteria
- Received 2-4 prior lines of therapy (escalation part) and 1-3 prior lines of therapy (expansion part) for multiple myeloma, consisting of at least 1 immunomodulatory drug (i.e., IKZF 1/3 degrader)
- ECOG performance status 0-2
Who cannot join
- Active plasma cell leukemia, Smoldering multiple myeloma, POEMS Syndrome, systemic light chain amyloidosis, MDS
- Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease
- Participants with any active, uncontrolled bacterial, fungal, or viral infection
- Prior treatment with a BCMA-directed TCE or BCMA-directed CAR-T therapy
- Administration with an investigational product within 30 days preceding the first dose of study intervention
- Inability or difficulty swallowing tablets, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
United States19 sites, 19 recruiting
- Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
- Recruiting
University of Maryland Greenbaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
- Recruiting
Perlmutter Cancer Center at NYU Langone Hospital
Brooklyn, New York, 11203
- Not yet recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
- Not yet recruiting
Baylor University Medical Center
Dallas, Texas, 75246
- Recruiting
Duke Cancer Center
Durham, North Carolina, 27710
- Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
- Not yet recruiting
Indiana University
Indianapolis, Indiana, 46202
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
- Recruiting
Norton Cancer Institute St. Matthews
Louisville, Kentucky, 40207
- Not yet recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
- Not yet recruiting
University of Miami
Miami, Florida, 33136
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
- Not yet recruiting
University of Nebraska
Omaha, Nebraska, 68105
- Recruiting
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
- Not yet recruiting
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
- Recruiting
UCLA Health, Jonsson Comprehensive Cancer Center
Santa Monica, California, 90404
About this study
Official title: A Phase 1B, Open-label, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
The main purpose of the study is to understand the safety and tolerability of cemsidomide when given along with elranatamab in subjects with relapsed or refractory multiple myeloma.
The first part of the study will evaluate different dose levels of cemsidomide in combination with elranatamab in a limited number of subjects. Approximately 3 different dose levels of cemsidomide in combination with elranatamab may be explored. Once a dose level is determined safe, additional subjects may be enrolled through expansion of the dose level. This expansion will provide further exploration of the safety and evaluation of preliminary antimyeloma activity.
Cemsidomide will be taken orally each cycle for 14 days on/14 days off (1 cycle=28 days). Elranatamab will be administered by subcutaneous injection twice a month. Dexamethasone will be administered weekly until a confirmed response but no longer than 4 cycles.
- Conditions
- Multiple Myeloma (MM)
- Being tested
- Cemsidomide, Elranatamab
- Keywords
- multiple myeloma, cemsidomide, CFT7455, elranatamab, PF-06863135, relapsed, refractory, RRMM, BCMA, bispecific antibody, BiTE, TCE, ELREXFIO
- Medical subject headings
- Multiple Myeloma, Recurrence, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemsidomideDrug
IKZF1/3 degrader
ElranatamabBiological
Also called o PF-06863135 o ELREXFIO
- BCMA-CD3 bispecific antibody
| Study group | Role | What they receive |
|---|---|---|
| Non-randomized cemsidomide (tablet) plus elranatamab (subcutaneous injection) | Experimental | Not described Receives: Drug: Cemsidomide; Biological: Elranatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of cemsidomide in combination with elranatamab
Dose limiting toxicity rate
Measured: Cycle 1 approximately 28 days
Safety and tolerability of cemsidomide in combination with elranatamab
Frequency and severity of AEs
Measured: Baseline through 30 days after discontinuation of study treatment
Secondary outcomes (4)
Assess antimyeloma activity
Objective Response Rate (ORR) per IMWG criteria
Measured: Approximately 2 years
Evaluate the PK of cemsidomide and elranatamab
Pre and post dose concentrations of cemsidomide
Measured: Approximately 4 months
Evaluate the PK of cemsidomide and elranatamab
Pre dose concentrations of elranatamab
Measured: Approximately 2 years
Assess the immunogenicity of elranatamab
Percent of participants with positive anti-drug antibodies to elranatamab
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start6 Feb 2026
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- C4 Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280013
- Sponsor's protocol ID
- CFT7455-1102
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 1B, Open-label, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
- ClinicalTrials.gov ID
- NCT07280013
- Acronym / sponsor ID
- CFT7455-1102
- Conditions
- Multiple Myeloma (MM)
- Keywords
- multiple myeloma, cemsidomide, CFT7455, elranatamab, PF-06863135, relapsed, refractory, RRMM, BCMA, bispecific antibody, BiTE, TCE, ELREXFIO
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- C4 Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 12 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.
The main purpose of the study is to understand the safety and tolerability of cemsidomide when given along with elranatamab in subjects with relapsed or refractory multiple myeloma.
The first part of the study will evaluate different dose levels of cemsidomide in combination with elranatamab in a limited number of subjects. Approximately 3 different dose levels of cemsidomide in combination with elranatamab may be explored. Once a dose level is determined safe, additional subjects may be enrolled through expansion of the dose level. This expansion will provide further exploration of the safety and evaluation of preliminary antimyeloma activity.
Cemsidomide will be taken orally each cycle for 14 days on/14 days off (1 cycle=28 days). Elranatamab will be administered by subcutaneous injection twice a month. Dexamethasone will be administered weekly until a confirmed response but no longer than 4 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-randomized cemsidomide (tablet) plus elranatamab (subcutaneous injection) | Experimental | Drug: Cemsidomide, Biological: Elranatamab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of multiple myeloma as defined by IMWG criteria
- Measurable disease based on IMWG criteria
- Received 2-4 prior lines of therapy (escalation part) and 1-3 prior lines of therapy (expansion part) for multiple myeloma, consisting of at least 1 immunomodulatory drug (i.e., IKZF 1/3 degrader)
- ECOG performance status 0-2
Key exclusion criteria (6 listed)
- Active plasma cell leukemia, Smoldering multiple myeloma, POEMS Syndrome, systemic light chain amyloidosis, MDS
- Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease
- Participants with any active, uncontrolled bacterial, fungal, or viral infection
- Prior treatment with a BCMA-directed TCE or BCMA-directed CAR-T therapy
- Administration with an investigational product within 30 days preceding the first dose of study intervention
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 |
|---|---|---|
| CemsidomideIKZF1/3 degrader | Drug | Non-randomized cemsidomide (tablet) plus elranatamab (subcutaneous injection) |
| ElranatamabAlso: o PF-06863135 o ELREXFIO• BCMA-CD3 bispecific antibody | Biological | Non-randomized cemsidomide (tablet) plus elranatamab (subcutaneous injection) |
Primary outcome
Safety and tolerability of cemsidomide in combination with elranatamab
Time frame: Cycle 1 approximately 28 days
Dose limiting toxicity rate
Safety and tolerability of cemsidomide in combination with elranatamab
Time frame: Baseline through 30 days after discontinuation of study treatment
Frequency and severity of AEs
4 secondary outcomes
Assess antimyeloma activity
Time frame: Approximately 2 years
Evaluate the PK of cemsidomide and elranatamab
Time frame: Approximately 4 months
Evaluate the PK of cemsidomide and elranatamab
Time frame: Approximately 2 years
Assess the immunogenicity of elranatamab
Time frame: Approximately 2 years
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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cemsidomide and Elranatamab in people with Multiple Myeloma (MM), run by C4 Therapeutics, Inc. at 19 sites in United States.
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 4 inclusion and 6 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 19 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety and tolerability of cemsidomide in combination with elranatamab (time frame: Cycle 1 approximately 28 days). The study lists 2 primary outcomes in all. 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.