Inobrodib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
DoMMino-1
A Phase II, Open-Label, Multicenter Study of Inobrodib in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
2 other identifiers
interventional
100
2 countries
20
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2026
Typical duration for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2025
CompletedFirst Posted
Study publicly available on registry
July 31, 2025
CompletedStudy Start
First participant enrolled
January 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
June 2, 2026
May 1, 2026
3.9 years
July 24, 2025
May 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
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
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 ICR
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 ICR
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 ICR
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 ICR
Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)
- +3 more secondary outcomes
Study Arms (1)
Inobrodib in combination with pomalidomide and dexamethasone
EXPERIMENTALInterventions
20 mg orally twice daily (b.i.d.) 4 days on / 3 days off for each 28-day cycle.
4 mg orally once daily on Day 1 to 21 of each 28-day cycle
40 mg orally once daily on Days 1, 8, 15 and 22 for each 28-day cycle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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; any antibody based therapy within 30 days
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CellCentric Ltd.lead
Study Sites (20)
University of California, San Francisco
San Francisco, California, 94143, United States
H Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
American Oncology Partners, PA
Bethesda, Maryland, 20817, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
The Christie NHS Foundation Trust
Withington, Greater Manchester, M20 4BX, United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, London, SM2 5PT, United Kingdom
University Hospital of Wales
Cardiff, Wales, CF14 4XW, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, Wirral, CH63 4JY, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Barts Health NHS Trust
London, EC1A 7BE, United Kingdom
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
Imperial College Healthcare NHS Trust, Hammersmith Hospital
London, W12 0HS, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Naseer Qayum
CellCentric Ltd.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2025
First Posted
July 31, 2025
Study Start
January 22, 2026
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
June 2, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
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.