Recruiting

Phase 3

Inobrodib & Pomalidomide & DexamethasoneInobrodib, Pomalidomide and Dexamethasone Versus Standard Available Therapy in Relapsed or Refractory Multiple Myeloma

Sponsor:

CellCentric Ltd.

Code:

NCT07772024

Conditions

Multiple Myeloma Refractory

Multiple Myeloma in Relapse

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

InoPd

Investigator's choice of SAT

Study Details

Brief summary:

The main purpose of this study is to find out whether inobrodib, when given with pomalidomide and dexamethasone, works better than standard treatment for people whose multiple myeloma has come back or has not improved after previous treatment. The study will look at how long people taking part in the study ("Participants") live without their myeloma getting worse, and how many people's myeloma improves (responds) following treatment.

The study will also look at how long participants live overall, how quickly treatment works, how long the response lasts, whether very small amounts of myeloma can still be found after a good response, quality of life, side effects, and the amount of inobrodib in the blood.

Participants receive treatment in 28-day cycles. One group receives inobrodib by mouth twice a day for 4 days, followed by 3 days without inobrodib each week; pomalidomide by mouth once a day on Days 1 to 21 of each cycle; and dexamethasone once each week.

The other group receives 1 standard treatment chosen by the study doctor from the following treatment options: daratumumab, pomalidomide, and dexamethasone; elotuzumab, pomalidomide, and dexamethasone; or carfilzomib and dexamethasone. Some standard treatments are given by injection or infusion at the study site. Other medicines, such as tablets or capsules, may be taken by mouth as instructed by the study team.

Study checks include questions about symptoms and side effects, review of other medicines, physical checks, blood pressure and other vital sign checks, heart tracing tests, blood and urine tests, scans where needed, bone marrow samples, and questionnaires about symptoms and daily life. Participants in the inobrodib group will have extra blood samples to measure the amount of inobrodib in the blood. Some participants may also have extra research blood samples at selected visits.

Conditions

Multiple Myeloma Refractory

Multiple Myeloma in Relapse

Study ID

NCT07772024

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Nov, 2031

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Adults aged 18 years or older (or the minimum age of consent under local rules, if that is 18 or over)
A diagnosis of multiple myeloma that has either come back (relapsed) or did not respond (refractory) after the most recent treatment
Myeloma that can be measured using standard study tests (blood and/or urine tests)
Between 1 and 4 previous courses (lines) of myeloma treatment, which must have included both a treatment that targets CD38 (such as daratumumab or isatuximab) and lenalidomide
Well enough to carry out daily activities with little or no help (Eastern Cooperative Oncology Group \[ECOG\] performance status of 0 to 2)
Suitable blood test results and adequate kidney and liver function
Willingness to use highly effective contraceptive measures (if sexually active) with all sexual partners

Exclusion Criteria:

Recent anticancer treatment before starting study treatment: any experimental medicine, chemotherapy, immunotherapy or other anticancer treatment within 14 days or 5 half-lives (whichever is shorter), or certain antibody-based treatments within longer set periods
Previous treatment with a medicine that works in the same way as inobrodib (a p300/CBP bromodomain inhibitor)
Myeloma that has already stopped responding to pomalidomide (pomalidomide-refractory), unless only short-term pomalidomide was used and the study doctor confirms the person still meets the study rules
Unable to receive at least one of the standard treatment options offered in the study, or unable/unwilling to follow the requirements for at least one of those options
Taking medicines, herbal supplements or foods (for example, strong CYP3A4 inducers or inhibitors) that would interfere with the study treatment
Major surgery within 4 weeks before the first dose of study treatment
A live vaccine within 4 weeks before study treatment
A recent stem cell transplant, or ongoing transplant-related problems such as graft-versus-host disease
Myeloma affecting the brain, spinal fluid or spinal cord, or ongoing pressure on the spinal cord
Another active cancer (progressing or needing a change in treatment) in the last 24 months, other than multiple myeloma, apart from certain low-risk or fully treated cancers
Serious or uncontrolled medical problems, such as uncontrolled heart, lung, liver, bleeding or diabetes conditions, uncontrolled high blood pressure, or a heart-rhythm problem (including QT prolongation)
An active or uncontrolled infection, including certain cases of HIV, hepatitis B or hepatitis C
Digestive problems that could stop the study medicines being swallowed or properly absorbed
Pregnant or breastfeeding, or planning to become pregnant, father a child or donate sperm during treatment or the required post-treatment period
Any illness or medical history that could affect safety, the ability to follow study requirements, or the interpretation of study results

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: InoPd

Inobrodib in combination with pomalidomide and dexamethasone

active comparator: Investigator's choice of Standard Available Therapy

Interventions

InoPd

Inobrodib in combination with pomalidomide and dexamethasone. Inobrodib 20 mg orally (PO) twice daily (b.i.d.), 4 days on/3 days off. Pomalidomide 4 mg PO once daily (o.d.) on Days 1 to 21 of each 28-day cycle. Dexamethasone 40 mg PO every week (q1w) (20 mg if >75 years old) on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment will continue until progressive disease, death, unacceptable side effects, withdrawal of consent or end of study, whichever occurs first.

Investigator's choice of SAT

Investigator's choice of elotuzumab in combination with pomalidomide and dexamethasone (EPd), daratumumab in combination with pomalidomide and dexamethasone (DPd), or carfilzomib in combination with dexamethasone (Kd). Treatment will continue until progressive disease, death, unacceptable side effects, withdrawal of consent or end of study, whichever occurs first.

Primary outcome measure

Progression-free Survival (PFS) assessed by Blinded Independent Central Review (BICR) [ Time Frame: From randomization until progressive disease or death, assessed every 28 days and followed until the final PFS analysis after approximately 330 PFS events; estimated up to approximately 38 months after the start of enrollment ]
Objective Response Rate (ORR) assessed by BICR [ Time Frame: From randomization until confirmed progressive disease, initiation of subsequent anticancer therapy, death, withdrawal, or the ORR data cutoff, whichever occurs first; disease response assessed every 28 days (up to 48 months) ]

Central Contacts and Locations

Central contacts

CCS1477-05 Clinical Operations

+44 1799 531130 DOMMINO-2@cellcentric.com

Locations

Regis Clinical Research

Recruiting

Miami, Florida, United States, 33126

More Information

Sponsor

CellCentric Ltd.

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

Inobrodib
Pomalidomide
Pomalyst
Imnovid
Dexamethasone
p300-CBP Transcription Factors
CCS1477

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CellCentric Ltd. on 2026-08-19.