Multiple Myeloma RefractoryPhase 3DOMMINO-2NCT07772024
Inobrodib, Pomalidomide and Dexamethasone Versus Standard Available Therapy in Relapsed or Refractory Multiple Myeloma
A Phase 3 study testing InoPd and Investigator's choice of SAT in people with Multiple Myeloma Refractory and Multiple Myeloma in Relapse, run by CellCentric Ltd. at 1 site in United States.
Trial 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. 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?
- InoPd and Investigator's choice of SAT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Nov 2031
- Phase
- Phase 3
- 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
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Regis Clinical Research
Miami, Florida, 33126
About this study
Official title: A Phase 3, Multicenter, Open-Label, Randomized Study to Evaluate Inobrodib in Combination With Pomalidomide and Dexamethasone Versus Standard Available Therapy in Patients With Relapsed or Refractory Multiple Myeloma
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.
Read more
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.
Read the detailed description
This is a Phase 3, multicenter, open-label, randomized study to evaluate inobrodib in combination with pomalidomide and dexamethasone (InoPd) versus standard available therapy (SAT), defined as Investigator's choice of daratumumab or elotuzumab in combination with pomalidomide and dexamethasone (DPd and EPd, respectively) or carfilzomib in combination with dexamethasone (Kd), in participants with relapsed or refractory multiple myeloma (RRMM).
Participants must be 18 years or older and have received 1 to 4 prior lines of therapy only.
Approximately 450 participants will be randomized 1:1 to be treated with either InoPd (Arm A) or Investigator's choice of SAT (Arm B), which includes DPd, EPd and Kd.
Study treatment should be continued until disease progression, initiation of new anticancer therapy, unacceptable toxicity or the participant meets any criteria for withdrawal from the study.
The dual primary objectives are to compare the efficacy of InoPd with Investigator's choice of SAT in terms of progression-free survival (PFS) and objective response rate (ORR) by Blinded Independent Central Review (BICR) in participants receiving InoPd versus participants receiving SAT.
The study will use a Steering Committee, consisting of selected participating Principal Investigators, Contract Research Organization (CRO) and Sponsor representatives, and an Independent Data Monitoring Committee (IDMC), for the purposes of conduct and oversight of the study.
- Being tested
- InoPd, Investigator's choice of SAT
- Keywords
- Inobrodib, Pomalidomide, Pomalyst, Imnovid, Dexamethasone, p300-CBP Transcription Factors, CCS1477
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InoPdDrug
Also called Inobrodib, CCS1477, Pomalidomide, Pomalyst
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 SATDrug
Also called Elotuzumab, Empliciti, Daratumumab, Darzalex
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.
| Study group | Role | What they receive |
|---|---|---|
| InoPd | Experimental | Inobrodib in combination with pomalidomide and dexamethasone Receives: Drug: InoPd |
| Investigator's choice of Standard Available Therapy | Active comparator | 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). Receives: Drug: Investigator's choice of SAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
Defined as the time from randomization until the earliest date of PD based on International Myeloma Working Group (IMWG) criteria assessed by BICR, or death due to any cause
Measured: 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
Defined as the percentage of participants with a confirmed PR or better, based on IMWG criteria assessed by BICR
Measured: 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)
Secondary outcomes (22)
Overall Survival (OS)
Defined as the time from randomization to the date of death due to any cause
Measured: From randomization until death from any cause or the final OS analysis after approximately 329 deaths; survival status assessed every 12 weeks after disease progression or treatment discontinuation (up to 48 months)
PFS Assessed by the Investigator
Defined as the time from randomization to the earliest occurrence of progressive disease, as determined by the Investigator according to IMWG response criteria, or death from any cause.
Measured: From randomization until progressive disease or death; disease assessments performed every 28 days until confirmed progression, death, withdrawal, loss to follow-up, or end of study (up to 48 months)
ORR Assessed by the Investigator
Percentage of participants with a confirmed PR or better as determined by the Investigator according to IMWG response criteria
Measured: From randomization until confirmed progressive disease, initiation of subsequent anticancer therapy, death, withdrawal, or end of study; assessed every 28 days (up to 48 months)
Minimal Residual Disease (MRD) Negativity Rate
Percentage of participants achieving minimal residual disease (MRD) negativity at CR or better, measured by next-generation sequencing
Measured: At confirmed CR or better; if MRD negativity is not demonstrated at CR, reassessed within 3 to 6 months after confirmation of CR or better (up to 48 months)
Duration of Response (DoR) Assessed by BICR
Defined, among participants with a confirmed PR or better, as the time from the first documented response to progressive disease determined by BICR or death from any cause, whichever occurs first
Measured: From the first documented confirmed response until progressive disease or death; assessed every 28 days until progression or end of study (up to 48 months)
DoR Assessed by the Investigator
Defined, among participants with a confirmed PR or better, as the time from the first documented response to progressive disease determined by the Investigator or death from any cause, whichever occurs first
Measured: From the first documented confirmed response until progressive disease or death; assessed every 28 days until progression or end of study (up to 48 months)
Time to Response (TTR) Assessed by BICR
Defined, among participants achieving a confirmed response, as the time from randomization to the first documented PR or better determined by BICR according to IMWG response criteria
Measured: From randomization to the first documented confirmed response; assessed every 28 days (up to 48 months)
TTR Assessed by the Investigator
Defined, among participants achieving a confirmed response, as the time from randomization to the first documented PR or better determined by the Investigator according to IMWG response criteria
Measured: From randomization to the first documented confirmed response; assessed every 28 days (up to 48 months)
Very Good Partial Response (VGPR) or Better Rate Assessed by BICR
Percentage of participants with a confirmed VGPR or better-VGPR, CR, or sCR-as determined by BICR according to IMWG response criteria
Measured: From randomization until progressive disease, initiation of subsequent anticancer therapy, death, withdrawal, or end of study; assessed every 28 days (up to 48 months)
VGPR or Better Rate Assessed by the Investigator
Percentage of participants with a confirmed VGPR or better as determined by the Investigator according to IMWG response criteria
Measured: From randomization until progressive disease, initiation of subsequent anticancer therapy, death, withdrawal, or end of study; assessed every 28 days (up to 48 months)
Complete Response (CR) or Better Rate Assessed by BICR
Percentage of participants with a confirmed CR or sCR as determined by BICR according to IMWG response criteria
Measured: From randomization until progressive disease, initiation of subsequent anticancer therapy, death, withdrawal, or end of study; assessed every 28 days (up to 48 months)
CR or Better Rate Assessed by the Investigator
Percentage of participants with a confirmed CR or sCR as determined by the Investigator according to IMWG response criteria
Measured: From randomization until progressive disease, initiation of subsequent anticancer therapy, death, withdrawal, or end of study; assessed every 28 days (up to 48 months)
Change From Baseline in EORTC QLQ-C30 Scores
Defined as the change from baseline in functional, symptom, and global health status/quality-of-life scores from the EORTC QLQ-C30 questionnaire
Measured: Assessed at baseline and protocol-specified visits during the first year, then every 3 months until treatment discontinuation, withdrawal, or the end of study (up to 48 months)
Change From Baseline in EORTC QLQ-MY20 Disease Symptoms Score
Defined as the change from baseline in the Disease Symptoms domain score of the EORTC QLQ-MY20 questionnaire
Measured: Assessed at baseline and protocol-specified visits during the first year, then every 3 months until treatment discontinuation, withdrawal, or the end of study (up to 48 months)
Change From Baseline in EQ-5D-5L Health Status
Defined as the change from baseline in the EQ-5D-5L health-state index and visual analogue scale scores
Measured: Assessed at baseline and protocol-specified visits during the first year, then every 3 months until treatment discontinuation, withdrawal, or the end of study (up to 48 months)
Treatment Side-Effect Bother Assessed by FACT-GP5
Defined as participants' responses to FACT-GP5 regarding how bothered they were by treatment side effects during the previous 7 days
Measured: Assessed at baseline and protocol-specified visits during the first year, then every 3 months until treatment discontinuation, withdrawal, or the end of study (up to 48 months)
Symptomatic Adverse Events Assessed by PRO-CTCAE
Defined as participant-reported frequency, severity, or interference of selected symptomatic adverse events using the PRO-CTCAE
Measured: Assessed at baseline and protocol-specified visits during the first year, then every 3 months until treatment discontinuation, withdrawal, or the end of study (up to 48 months)
Participants With Treatment-Emergent Adverse Events
Defined as the number and percentage of participants with adverse events that begin or worsen after the first dose of study treatment
Measured: Assessed from the first dose of study treatment through 28 days after the last dose (up to 48 months)
Change From Baseline in Electrocardiogram Parameters
Defined as changes from baseline and clinically significant abnormalities in protocol-specified 12-lead electrocardiogram parameters
Measured: Assessed at baseline and protocol-specified visits during treatment through the 28-day post-treatment follow-up visit (up to 48 months)
Change From Baseline in Vital Signs
Defined as changes from baseline and clinically significant abnormalities in protocol-specified vital-sign measurements
Measured: Assessed at baseline and protocol-specified visits during treatment through the 28-day post-treatment follow-up visit (up to 48 months)
Participants With Laboratory Abnormalities
Defined as the number and percentage of participants with hematology, chemistry, or other protocol-specified laboratory abnormalities
Measured: Assessed at baseline and protocol-specified visits during treatment through the 28-day post-treatment follow-up visit (up to 48 months)
Plasma Concentrations of Inobrodib
Defined as the measured plasma concentrations of inobrodib and, where analyzed, its primary metabolite CCS1532
Measured: Assessed at protocol-specified predose and postdose time points during treatment (up to 48 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2031 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CellCentric Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, CellCentric Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772024
- Sponsor's protocol ID
- CCS1477-05
- Acronym
- DOMMINO-2
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Open-Label, Randomized Study to Evaluate Inobrodib in Combination With Pomalidomide and Dexamethasone Versus Standard Available Therapy in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07772024
- Acronym / sponsor ID
- DOMMINO-2 / CCS1477-05
- Keywords
- Inobrodib, Pomalidomide, Pomalyst, Imnovid, Dexamethasone, p300-CBP Transcription Factors, CCS1477
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- CellCentric Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 19 Aug 2026 (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 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.
Detailed description
This is a Phase 3, multicenter, open-label, randomized study to evaluate inobrodib in combination with pomalidomide and dexamethasone (InoPd) versus standard available therapy (SAT), defined as Investigator's choice of daratumumab or elotuzumab in combination with pomalidomide and dexamethasone (DPd and EPd, respectively) or carfilzomib in combination with dexamethasone (Kd), in participants with relapsed or refractory multiple myeloma (RRMM).
Participants must be 18 years or older and have received 1 to 4 prior lines of therapy only.
Approximately 450 participants will be randomized 1:1 to be treated with either InoPd (Arm A) or Investigator's choice of SAT (Arm B), which includes DPd, EPd and Kd.
Study treatment should be continued until disease progression, initiation of new anticancer therapy, unacceptable toxicity or the participant meets any criteria for withdrawal from the study.
The dual primary objectives are to compare the efficacy of InoPd with Investigator's choice of SAT in terms of progression-free survival (PFS) and objective response rate (ORR) by Blinded Independent Central Review (BICR) in participants receiving InoPd versus participants receiving SAT.
The study will use a Steering Committee, consisting of selected participating Principal Investigators, Contract Research Organization (CRO) and Sponsor representatives, and an Independent Data Monitoring Committee (IDMC), for the purposes of conduct and oversight of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| InoPd | Experimental | Drug: InoPdInobrodib in combination with pomalidomide and dexamethasone |
| Investigator's choice of Standard Available Therapy | Active comparator | Drug: Investigator's choice of SATInvestigator'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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| InoPdAlso: Inobrodib, CCS1477, Pomalidomide, PomalystInobrodib 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. | Drug | InoPd |
| Investigator's choice of SATAlso: Elotuzumab, Empliciti, Daratumumab, DarzalexInvestigator'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. | Drug | Investigator's choice of Standard Available Therapy |
Primary outcome
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
Defined as the time from randomization until the earliest date of PD based on International Myeloma Working Group (IMWG) criteria assessed by BICR, or death due to any cause
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)
Defined as the percentage of participants with a confirmed PR or better, based on IMWG criteria assessed by BICR
22 secondary outcomes
Overall Survival (OS)
Time frame: From randomization until death from any cause or the final OS analysis after approximately 329 deaths; survival status assessed every 12 weeks after disease progression or treatment discontinuation (up to 48 months)
PFS Assessed by the Investigator
Time frame: From randomization until progressive disease or death; disease assessments performed every 28 days until confirmed progression, death, withdrawal, loss to follow-up, or end of study (up to 48 months)
ORR Assessed by the Investigator
Time frame: From randomization until confirmed progressive disease, initiation of subsequent anticancer therapy, death, withdrawal, or end of study; assessed every 28 days (up to 48 months)
Minimal Residual Disease (MRD) Negativity Rate
Time frame: At confirmed CR or better; if MRD negativity is not demonstrated at CR, reassessed within 3 to 6 months after confirmation of CR or better (up to 48 months)
Duration of Response (DoR) Assessed by BICR
Time frame: From the first documented confirmed response until progressive disease or death; assessed every 28 days until progression or end of study (up to 48 months)
DoR Assessed by the Investigator
Time frame: From the first documented confirmed response until progressive disease or death; assessed every 28 days until progression or end of study (up to 48 months)
Time to Response (TTR) Assessed by BICR
Time frame: From randomization to the first documented confirmed response; assessed every 28 days (up to 48 months)
TTR Assessed by the Investigator
Time frame: From randomization to the first documented confirmed response; assessed every 28 days (up to 48 months)
Very Good Partial Response (VGPR) or Better Rate Assessed by BICR
Time frame: From randomization until progressive disease, initiation of subsequent anticancer therapy, death, withdrawal, or end of study; assessed every 28 days (up to 48 months)
VGPR or Better Rate Assessed by the Investigator
Time frame: From randomization until progressive disease, initiation of subsequent anticancer therapy, death, withdrawal, or end of study; assessed every 28 days (up to 48 months)
Complete Response (CR) or Better Rate Assessed by BICR
Time frame: From randomization until progressive disease, initiation of subsequent anticancer therapy, death, withdrawal, or end of study; assessed every 28 days (up to 48 months)
CR or Better Rate Assessed by the Investigator
Time frame: From randomization until progressive disease, initiation of subsequent anticancer therapy, death, withdrawal, or end of study; assessed every 28 days (up to 48 months)
Change From Baseline in EORTC QLQ-C30 Scores
Time frame: Assessed at baseline and protocol-specified visits during the first year, then every 3 months until treatment discontinuation, withdrawal, or the end of study (up to 48 months)
Change From Baseline in EORTC QLQ-MY20 Disease Symptoms Score
Time frame: Assessed at baseline and protocol-specified visits during the first year, then every 3 months until treatment discontinuation, withdrawal, or the end of study (up to 48 months)
Change From Baseline in EQ-5D-5L Health Status
Time frame: Assessed at baseline and protocol-specified visits during the first year, then every 3 months until treatment discontinuation, withdrawal, or the end of study (up to 48 months)
Treatment Side-Effect Bother Assessed by FACT-GP5
Time frame: Assessed at baseline and protocol-specified visits during the first year, then every 3 months until treatment discontinuation, withdrawal, or the end of study (up to 48 months)
Symptomatic Adverse Events Assessed by PRO-CTCAE
Time frame: Assessed at baseline and protocol-specified visits during the first year, then every 3 months until treatment discontinuation, withdrawal, or the end of study (up to 48 months)
Participants With Treatment-Emergent Adverse Events
Time frame: Assessed from the first dose of study treatment through 28 days after the last dose (up to 48 months)
Change From Baseline in Electrocardiogram Parameters
Time frame: Assessed at baseline and protocol-specified visits during treatment through the 28-day post-treatment follow-up visit (up to 48 months)
Change From Baseline in Vital Signs
Time frame: Assessed at baseline and protocol-specified visits during treatment through the 28-day post-treatment follow-up visit (up to 48 months)
Participants With Laboratory Abnormalities
Time frame: Assessed at baseline and protocol-specified visits during treatment through the 28-day post-treatment follow-up visit (up to 48 months)
Plasma Concentrations of Inobrodib
Time frame: Assessed at protocol-specified predose and postdose time points during treatment (up to 48 months)
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 19 Aug 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.
Study Director study director
CellCentric Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing InoPd and Investigator's choice of SAT in people with Multiple Myeloma Refractory and Multiple Myeloma in Relapse, run by CellCentric Ltd. at 1 site 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 7 inclusion and 15 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 CCS1477-05 Clinical Operations (+44 1799 531130, DOMMINO-2@cellcentric.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). 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 19 Aug 2026.