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

17 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

450

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Florida
      • Miami, Florida, États-Unis, 33126
        • Recrutement
        • Regis Clinical Research

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: InoPd
Inobrodib in combination with pomalidomide and dexamethasone
Médicament: 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.
Autres noms:
  • Pomalyste
  • Dexaméthasone
  • Imnovid
  • Pomalidomide
  • CCS1477
  • Inobrodib
Comparateur actif: 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).
Médicament: 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.
Autres noms:
  • Pomalyste
  • Kyprolis
  • Darzalex
  • Dexaméthasone
  • Imnovid
  • Empliciti
  • Darzalex Faspro
  • Carfilzomib
  • Pomalidomide
  • Daratumumab
  • Élotuzumab

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Progression-free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
Délai: 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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Overall Survival (OS)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

CellCentric Ltd.

Les enquêteurs

  • Directeur d'études: Study Director, CellCentric Ltd.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

1 novembre 2029

Achèvement de l'étude (Estimé)

1 novembre 2031

Dates d'inscription aux études

Première soumission

13 août 2026

Première soumission répondant aux critères de contrôle qualité

17 août 2026

Première publication (Réel)

19 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CCS1477-05

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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