Multiple Myeloma RefractoryPhase 2DOMMINO-1NCT07096778
Inobrodib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing Inobrodib, Pomalidomide and Dexamethasone in people with Multiple Myeloma Refractory and Multiple Myeloma in Relapse, run by CellCentric Ltd. at 31 sites in 2 countries.
Trial summary
The purpose of this study is to learn more about the anti-cancer activity of inobrodib, when given in combination with pomalidomide and dexamethasone, in patients with multiple myeloma that has come back following treatment and which no longer responds to available therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma Refractory, Multiple Myeloma in Relapse
- What is being tested?
- Inobrodib, Pomalidomide 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
- 31 sitesin 2 countries
- Study dates
- 22 Jan 2026to 1 Dec 2029
- 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
- Male or female ≥18 years of age
- Prior diagnosis of MM as defined according to IMWG criteria and relapsed or refractory to the last line of therapy
- Eastern Co-operative Oncology Group (ECOG) performance status of 0 to 2
- Adequate hematological, renal and hepatic function
- Willingness to use highly effective contraceptive measures (if sexually active) with all sexual partners
Who cannot join
- Use of any investigational agent, chemotherapy, immunotherapy or anticancer agent from a previous clinical study within 14 days or 5 half-lives of first dose of study treatment, whichever is shortest
- Prior treatment with p300/CBP bromodomain inhibitors
- Known or suspected severe allergies to any active or inactive ingredients in the study medications (inobrodib, pomalidomide, dexamethasone) or any prior immunomodulatory drug (lenalidomide, thalidomide)
- Treatment with medicines or herbal supplements or foods (e.g. strong CYP3A4 inducers or inhibitors) that would interfere with treatment
- Major surgery within 4 weeks of the first dose of study treatment
- Live vaccine within 4 weeks of study treatment
Show all 10Show fewer
- Active or unresolved adverse events
- Active malignancies (progressing or requiring change in treatment) in the last 24 months other than multiple myeloma
- Female patients who are pregnant or breast-feeding at any time during the study
- Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data
Trial locations and contacts
31 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
31 sites in 2 countries
United States21 sites, 21 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
- Recruiting
Winship Cancer Institute
Atlanta, Georgia, 30322
- Recruiting
American Oncology Partners, PA
Bethesda, Maryland, 20817
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
- Recruiting
University of Iowa Health Care
Iowa City, Iowa, 52242
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
- Recruiting
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
- Recruiting
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
- Recruiting
Mayo Clinic Arizona
Phoenix, Arizona, 85054
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
- Recruiting
H Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United Kingdom10 sites, 10 recruiting
- Recruiting
The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, Wirral, CH63 4JY
- Recruiting
University Hospital of Wales
Cardiff, Wales, CF14 4XW
- Recruiting
Western General Hospital
Edinburgh, EH4 2XU
- Recruiting
Barts Health NHS Trust
London, EC1A 7BE
- Recruiting
King's College Hospital NHS Foundation Trust
London, SE5 9RS
- Recruiting
Imperial College Healthcare NHS Trust, Hammersmith Hospital
London, W12 0HS
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE
- Recruiting
University Hospital Southampton NHS Trust, Southampton General Hospital
Southampton, SO16 6YD
- Recruiting
Royal Marsden NHS Foundation Trust
Sutton, London, SM2 5PT
- Recruiting
The Christie NHS Foundation Trust
Withington, Greater Manchester, M20 4BX
About this study
Official title: A Phase II, Open-Label, Multicenter Study of Inobrodib in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to learn more about the anti-cancer activity of inobrodib, when given in combination with pomalidomide and dexamethasone, in patients with multiple myeloma that has come back following treatment and which no longer responds to available therapies. The study treatment will not be compared to any other treatment and patients will know what treatment they are receiving. This study will also further explore the side effects of inobrodib in combination with these other medicines.
Read the detailed description
This is a Phase II, open-label, multicenter study to evaluate the efficacy and safety of inobrodib in combination with pomalidomide and dexamethasone (InoPd) in patients with relapsed and refractory multiple myeloma (RRMM).
Patients must be 18 years or older and be refractory to least one proteosome inhibitor (PI), one anti-CD38 monoclonal antibody (mAb) and pomalidomide. Patients must also be previously treated with an approved bispecific T-cell engager [TCE].
Approximately 100 patients will be treated with 20 mg of inobrodib administered orally twice daily (b.i.d.) 4 days on / 3 days off for each 28-day cycle. Pomalidomide and dexamethasone will be administered as per standard of care (SoC), i.e., with a starting dose of 4 mg orally once daily on Day 1 to 21 of each 28-day cycle for pomalidomide, and 40 mg orally once daily on Days 1, 8, 15 and 22 for each 28-day cycle for dexamethasone. Study treatment should be continued until disease progression, initiation of new anticancer therapy, unacceptable toxicity or the patient meets any criteria for withdrawal from the study.
The primary objective is to assess the efficacy of InoPd in terms of objective response rate (ORR) based on International Myeloma Working Group (IMWG) criteria and assessed by Independent Review Committee (IRC).
- Being tested
- Inobrodib, Pomalidomide, Dexamethasone
- Keywords
- Inobrodib, Pomalidomide, Pomalyst, Imnovid, Dexamethasone, p300-CBP Transcription Factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InobrodibDrug
Also called CCS1477
20 mg orally twice daily (b.i.d.) 4 days on / 3 days off for each 28-day cycle.
PomalidomideDrug
Also called Pomalyst, Imnovid
4 mg orally once daily on Day 1 to 21 of each 28-day cycle
DexamethasoneDrug
40 mg orally once daily on Days 1, 8, 15 and 22 for each 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Inobrodib in combination with pomalidomide and dexamethasone | Experimental | Not described Receives: Drug: Inobrodib; Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate, defined as the percentage of patients with a confirmed partial response (PR) or better, based on IMWG criteria and assessed by Independent Review Committee (IRC)
Measured: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)
Secondary outcomes (8)
ORR, defined as the percentage of patients with a confirmed PR or better, based on IMWG criteria assessed by Investigator
Measured: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)
Duration of Response (DoR), defined as the duration of overall response by investigator and IRC
Measured: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)
Time to Response (TTR), defined as time to confirmed PR or better, by investigator and IRC
Measured: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)
Very Good Partial Response (VGPR) or better rate, defined as the percentage of patients with a confirmed VGPR or better, based on IMWG criteria and assessed by investigator and IRC
Measured: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)
Complete Response (CR) or better rate, defined as the percentage of patients with a confirmed CR or better, based on IMWG criteria and assessed by investigator and IRC
Measured: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)
Progression Free Survival (PFS), defined as the time from enrolment until the earliest date of Progressive Disease (PD), or death due to any cause, and assessed by investigator and IRC
Measured: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)
Overall Survival (OS), defined as the time from enrolment to the date of death due to any cause
Measured: Assessed from enrollment to date of death from any cause, until the end of study (up to 48 months)
Incidence of treatment-emergent adverse events (TEAEs), vital signs and laboratory abnormalities
Measured: Assessed from start of treatment until 28 days after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start22 Jan 2026
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 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 RefractoryStudies 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
- CellCentric Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naseer Qayum, Study director, CellCentric Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096778
- Sponsor's protocol ID
- CCS1477-04
- Other IDs
- 1012518
- Acronym
- DOMMINO-1
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The final clinical study report will be provided to the Investigators. The Sponsor will publicly disclose study results through posting on ClinicalTrials.gov and any other applicable public registries in accordance with local regulations.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Multicenter Study of Inobrodib in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07096778
- Acronym / sponsor ID
- DOMMINO-1 / CCS1477-04
- Keywords
- Inobrodib, Pomalidomide, Pomalyst, Imnovid, Dexamethasone, p300-CBP Transcription Factors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CellCentric Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 31 Jul 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 purpose of this study is to learn more about the anti-cancer activity of inobrodib, when given in combination with pomalidomide and dexamethasone, in patients with multiple myeloma that has come back following treatment and which no longer responds to available therapies. The study treatment will not be compared to any other treatment and patients will know what treatment they are receiving. This study will also further explore the side effects of inobrodib in combination with these other medicines.
Detailed description
This is a Phase II, open-label, multicenter study to evaluate the efficacy and safety of inobrodib in combination with pomalidomide and dexamethasone (InoPd) in patients with relapsed and refractory multiple myeloma (RRMM).
Patients must be 18 years or older and be refractory to least one proteosome inhibitor (PI), one anti-CD38 monoclonal antibody (mAb) and pomalidomide. Patients must also be previously treated with an approved bispecific T-cell engager [TCE].
Approximately 100 patients will be treated with 20 mg of inobrodib administered orally twice daily (b.i.d.) 4 days on / 3 days off for each 28-day cycle. Pomalidomide and dexamethasone will be administered as per standard of care (SoC), i.e., with a starting dose of 4 mg orally once daily on Day 1 to 21 of each 28-day cycle for pomalidomide, and 40 mg orally once daily on Days 1, 8, 15 and 22 for each 28-day cycle for dexamethasone. Study treatment should be continued until disease progression, initiation of new anticancer therapy, unacceptable toxicity or the patient meets any criteria for withdrawal from the study.
The primary objective is to assess the efficacy of InoPd in terms of objective response rate (ORR) based on International Myeloma Working Group (IMWG) criteria and assessed by Independent Review Committee (IRC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inobrodib in combination with pomalidomide and dexamethasone | Experimental | Drug: Inobrodib, Drug: Pomalidomide, Drug: Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥18 years of age
- Prior diagnosis of MM as defined according to IMWG criteria and relapsed or refractory to the last line of therapy
- Eastern Co-operative Oncology Group (ECOG) performance status of 0 to 2
- Adequate hematological, renal and hepatic function
- Willingness to use highly effective contraceptive measures (if sexually active) with all sexual partners
Key exclusion criteria (10 listed)
- Use of any investigational agent, chemotherapy, immunotherapy or anticancer agent from a previous clinical study within 14 days or 5 half-lives of first dose of study treatment, whichever is shortest
- Prior treatment with p300/CBP bromodomain inhibitors
- Known or suspected severe allergies to any active or inactive ingredients in the study medications (inobrodib, pomalidomide, dexamethasone) or any prior immunomodulatory drug (lenalidomide, thalidomide)
- Treatment with medicines or herbal supplements or foods (e.g. strong CYP3A4 inducers or inhibitors) that would interfere with treatment
- Major surgery within 4 weeks of the first dose of study treatment
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 |
|---|---|---|
| InobrodibAlso: CCS147720 mg orally twice daily (b.i.d.) 4 days on / 3 days off for each 28-day cycle. | Drug | Inobrodib in combination with pomalidomide and dexamethasone |
| PomalidomideAlso: Pomalyst, Imnovid4 mg orally once daily on Day 1 to 21 of each 28-day cycle | Drug | Inobrodib in combination with pomalidomide and dexamethasone |
| Dexamethasone40 mg orally once daily on Days 1, 8, 15 and 22 for each 28-day cycle | Drug | Inobrodib in combination with pomalidomide and dexamethasone |
Primary outcome
Objective Response Rate, defined as the percentage of patients with a confirmed partial response (PR) or better, based on IMWG criteria and assessed by Independent Review Committee (IRC)
Time frame: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)
8 secondary outcomes
ORR, defined as the percentage of patients with a confirmed PR or better, based on IMWG criteria assessed by Investigator
Time frame: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)
Duration of Response (DoR), defined as the duration of overall response by investigator and IRC
Time frame: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)
Time to Response (TTR), defined as time to confirmed PR or better, by investigator and IRC
Time frame: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)
Very Good Partial Response (VGPR) or better rate, defined as the percentage of patients with a confirmed VGPR or better, based on IMWG criteria and assessed by investigator and IRC
Time frame: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)
Complete Response (CR) or better rate, defined as the percentage of patients with a confirmed CR or better, based on IMWG criteria and assessed by investigator and IRC
Time frame: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)
Progression Free Survival (PFS), defined as the time from enrolment until the earliest date of Progressive Disease (PD), or death due to any cause, and assessed by investigator and IRC
Time frame: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)
Overall Survival (OS), defined as the time from enrolment to the date of death due to any cause
Time frame: Assessed from enrollment to date of death from any cause, until the end of study (up to 48 months)
Incidence of treatment-emergent adverse events (TEAEs), vital signs and laboratory abnormalities
Time frame: Assessed from start of treatment until 28 days after end of treatment
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 21 Sep 2026.
- Individual participant dataSharing planned: No. The final clinical study report will be provided to the Investigators. The Sponsor will publicly disclose study results through posting on ClinicalTrials.gov and any other applicable public registries in accordance with local regulations.
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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.
Naseer Qayum study director
CellCentric Ltd.
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inobrodib, Pomalidomide and Dexamethasone in people with Multiple Myeloma Refractory and Multiple Myeloma in Relapse, run by CellCentric Ltd. at 31 sites in 2 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 5 inclusion and 10 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 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, United Kingdom. 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 CCS1477-04 Clinical Operations (+44 1799 531130, DOMMINO-1@cellcentric.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate, defined as the percentage of patients with a confirmed partial response (PR) or better, based on IMWG criteria and assessed by Independent Review Committee (IRC) (time frame: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 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 21 Sep 2026.