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Inobrodib, Pomalidomide and Dexamethasone Versus Standard Available Therapy in Relapsed or Refractory Multiple Myeloma (DOMMINO-2)

17. august 2026 opdateret af: CellCentric Ltd.

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.

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

450

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Florida
      • Miami, Florida, Forenede Stater, 33126
        • Rekruttering
        • Regis Clinical Research

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: InoPd
Inobrodib in combination with pomalidomide and dexamethasone
Medicin: 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.
Andre navne:
  • Pomalyst
  • Dexamethason
  • Imnovid
  • Pomalidomid
  • CCS1477
  • Inobrodib
Aktiv komparator: Investigator's choice of Standard Available Therapy
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).
Medicin: 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.
Andre navne:
  • Pomalyst
  • Kyprolis
  • Darzalex
  • Dexamethason
  • Imnovid
  • Empliciti
  • Darzalex Faspro
  • Carfilzomib
  • Pomalidomid
  • Daratumumab
  • Elotuzumab

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
Tidsramme: 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
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
Tidsramme: 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
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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: 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)
Defined as the time from randomization to the date of death due to any cause
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
Tidsramme: 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)
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.
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
Tidsramme: 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)
Percentage of participants with a confirmed PR or better as determined by the Investigator according to IMWG response criteria
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
Tidsramme: 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)
Percentage of participants achieving minimal residual disease (MRD) negativity at CR or better, measured by next-generation sequencing
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
Tidsramme: 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)
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
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
Tidsramme: 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)
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
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
Tidsramme: From randomization to the first documented confirmed response; assessed every 28 days (up to 48 months)
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
From randomization to the first documented confirmed response; assessed every 28 days (up to 48 months)
TTR Assessed by the Investigator
Tidsramme: From randomization to the first documented confirmed response; assessed every 28 days (up to 48 months)
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
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
Tidsramme: From randomization until progressive disease, initiation of subsequent anticancer therapy, death, withdrawal, or end of study; assessed every 28 days (up to 48 months)
Percentage of participants with a confirmed VGPR or better-VGPR, CR, or sCR-as determined by BICR according to IMWG response criteria
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
Tidsramme: From randomization until progressive disease, initiation of subsequent anticancer therapy, death, withdrawal, or end of study; assessed every 28 days (up to 48 months)
Percentage of participants with a confirmed VGPR or better as determined by the Investigator according to IMWG response criteria
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
Tidsramme: From randomization until progressive disease, initiation of subsequent anticancer therapy, death, withdrawal, or end of study; assessed every 28 days (up to 48 months)
Percentage of participants with a confirmed CR or sCR as determined by BICR according to IMWG response criteria
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
Tidsramme: From randomization until progressive disease, initiation of subsequent anticancer therapy, death, withdrawal, or end of study; assessed every 28 days (up to 48 months)
Percentage of participants with a confirmed CR or sCR as determined by the Investigator according to IMWG response criteria
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
Tidsramme: 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)
Defined as the change from baseline in functional, symptom, and global health status/quality-of-life scores from the EORTC QLQ-C30 questionnaire
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
Tidsramme: 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)
Defined as the change from baseline in the Disease Symptoms domain score of the EORTC QLQ-MY20 questionnaire
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
Tidsramme: 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)
Defined as the change from baseline in the EQ-5D-5L health-state index and visual analogue scale scores
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
Tidsramme: 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)
Defined as participants' responses to FACT-GP5 regarding how bothered they were by treatment side effects during the previous 7 days
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
Tidsramme: 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)
Defined as participant-reported frequency, severity, or interference of selected symptomatic adverse events using the PRO-CTCAE
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
Tidsramme: Assessed from the first dose of study treatment through 28 days after the last dose (up to 48 months)
Defined as the number and percentage of participants with adverse events that begin or worsen after the first dose of study treatment
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
Tidsramme: Assessed at baseline and protocol-specified visits during treatment through the 28-day post-treatment follow-up visit (up to 48 months)
Defined as changes from baseline and clinically significant abnormalities in protocol-specified 12-lead electrocardiogram parameters
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
Tidsramme: Assessed at baseline and protocol-specified visits during treatment through the 28-day post-treatment follow-up visit (up to 48 months)
Defined as changes from baseline and clinically significant abnormalities in protocol-specified vital-sign measurements
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
Tidsramme: Assessed at baseline and protocol-specified visits during treatment through the 28-day post-treatment follow-up visit (up to 48 months)
Defined as the number and percentage of participants with hematology, chemistry, or other protocol-specified laboratory abnormalities
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
Tidsramme: Assessed at protocol-specified predose and postdose time points during treatment (up to 48 months)
Defined as the measured plasma concentrations of inobrodib and, where analyzed, its primary metabolite CCS1532
Assessed at protocol-specified predose and postdose time points during treatment (up to 48 months)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

CellCentric Ltd.

Efterforskere

  • Studieleder: Study Director, CellCentric Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. november 2029

Studieafslutning (Anslået)

1. november 2031

Datoer for studieregistrering

Først indsendt

13. august 2026

Først indsendt, der opfyldte QC-kriterier

17. august 2026

Først opslået (Faktiske)

19. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CCS1477-05

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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