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A Multicenter Study of Belantamab Mafodotin and Mezigdomide in Patients With Relapsed Multiple Myeloma (BELAMI)

11 juin 2026 mis à jour par: Centre Hospitalier Universitaire de Saint Etienne

A Multicenter Phase 2 Study of Belantamab Mafodotin and Mezigdomide in Combination With a Phase Ib Safety Run in Patients With Relapsed Multiple Myeloma Following BCMA-targeting CAR-T Cells or Bispecific Antibodies

The BELAMI trial is an open label, multicenter, phase 2 study for patients with MM who relapsed following BCMA-directed CAR-T cells or bispecific antibodies with a Phase Ib Safety run-in.

The primary hypothesis of this study is that a combination of ADC targeting BCMA and CELMoD will be efficient for these patients.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

CAR-T cells and bispecific antibodies targeting BCMA have been approved in the treatment of patients with multiple myeloma (MM), at late stage of disease. Data from real-world situations showed poor outcomes of patients who relapsed following these treatments. Belantamab mafodotin is an antibody-drug conjugate (ADC) targeting BCMA. Mezigdomide is a novel oral CELMoD® agent (oral cereblon-modulating) with enhanced tumoricidal and immune-stimulatory effects compared to immunomodulatory drugs. The ALGONQUIN trial demonstrated that the anti-myeloma activities of Belantamab mafodontin were significantly increased by immunomodulatory drugs. In this context, investigator aim to evaluate Belantamab mafodontin in association with Mezigdomide.

Type d'étude

Interventionnel

Inscription (Estimé)

44

Phase

  • Phase 2
  • La phase 1

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

  • France
      • Amiens, France, 80000
        • Centre Hospitalier Universitaire
        • Contact:
      • Angers, France, 49100
        • Centre Hospitalier Universitaire
        • Contact:
          • Mamoun DIB, MD
          • Numéro de téléphone: +33 (0)2 41 35 36 37
      • Annecy, France, 74370
        • Centre Hospitalier Universitaire
        • Contact:
          • Frédérique ORSINI-PIOCELLE, MD
          • Numéro de téléphone: +33 (0)4 50 63 63 63
      • Argenteuil, France, 95107
        • Centre Hospitalier d'Argenteuil
        • Contact:
          • EMMANUELLE LE RAY, MD
          • Numéro de téléphone: +33 (0)1 34 23 24 25
      • Bayonne, France, 64100
        • Centre Hospitalier de la Côte Basque
        • Contact:
          • Julie GAY, MD
          • Numéro de téléphone: +33 (0)559443535
      • Bordeaux, France, 33076
        • Institut Bergonie
        • Contact:
          • Anna SCHMITT, MD
          • Numéro de téléphone: +33 (0)5 56 33 33 33
      • Brest, France, 29200
      • Caen, France, 14008
        • Centre Hospitalier Universitaire
        • Contact:
          • Margaret MACRO, MD
          • Numéro de téléphone: +33 (0)231063106
      • Clermont-Ferrand, France, 63003
        • Centre Hospitalier Universitaire
        • Contact:
          • Carolyne CROIZIER, MD
          • Numéro de téléphone: +33 (0)4 73 750 750
      • Dijon, France, 21000
        • Centre Hospitalier Universitaire
        • Contact:
          • Andréa PIERAGOSTINI, MD
          • Numéro de téléphone: +33 (0)380293031
      • Grenoble, France, 38700
        • Centre Hospitalier Universitaire
        • Contact:
          • Clara MARIETTE, MD
          • Numéro de téléphone: +33 (0)476767575
      • Le Mans, France, 72037
        • Centre Hospitalier
        • Contact:
          • Kamel LARIBI, MD
          • Numéro de téléphone: +33 (0)2 43 43 43 43
      • Lille, France, 59000
        • Centre Hospitalier Universitaire
        • Contact:
      • Limoges, France, 87000
        • Centre Hospitalier Universitaire
        • Contact:
          • Murielle ROUSSEL, MD
          • Numéro de téléphone: +33 (0)5 55 05 55 55
      • Lyon, France, 69000
      • Nancy, France, 54500
        • Centre Hospitalier Regional Et Universitaire
        • Contact:
          • Caroline JACQUET, MD
          • Numéro de téléphone: +33 (0)3 83 85 85 85
      • Nantes, France, 44093
        • Centre Hospitalier Universitaire
        • Contact:
      • Nantes, France, 44000
      • Nice, France, 06000
        • Centre Hospitalier Universitaire
        • Contact:
      • Orléans, France, 45100
        • Centre Hospitalier Universitaire
        • Contact:
          • Marlène OCHMANN, MD
          • Numéro de téléphone: +33 (0)2 38 51 44 44
      • Paris, France, 75013
        • APHP - La Pitié Salpétrière
        • Contact:
      • Paris, France, 75014
        • Hôpital Cochin
        • Contact:
          • Marguerite VIGNON, MD
          • Numéro de téléphone: +33 (0)158414141
      • Paris, France, 75012
        • Hôpital St Antoine
        • Contact:
          • Mohamad MOTHY, MD
          • Numéro de téléphone: +33 (0)1 49 28 20 00
      • Paris, France, 75010
        • Centre Hospitalier Universitaire
        • Contact:
          • Bertrand ARNULF, PHD
          • Numéro de téléphone: +33 (0)1 42 49 49 49
      • Poitiers, France, 86000
        • Centre Hospitalier de Poitiers
        • Contact:
          • Arthur BOBIN, MD
          • Numéro de téléphone: +33 (0)5 49 44 44 44
      • Rouen, France, 76038
        • Centre Henri Becquerel
        • Contact:
          • Pascal LENAIN, MD
          • Numéro de téléphone: +33 (0)2 32 08 22 22
      • Saint-Etienne, France, 42055
      • Strasbourg, France, 67200
        • ICANS
        • Contact:
          • Céline SONNTAG, MD
          • Numéro de téléphone: +33 (0)3 68 76 65 65
      • Toulouse, France, 31100
        • IUCT
        • Contact:
          • Aurore PERROT, PHD
      • Tours, France, 37000
        • Centre Hospitalier Universitaire
        • Contact:

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:

  • Subjects who are ≥ 18 years of age
  • Participant has a histologically or cytologically confirmed diagnosis of MM as defined by IMWG criteria
  • Participant has Eastern Cooperative Oncology Group (ECOG) performance status of score of 0, 1, or 2
  • Participant is considered transplant ineligible or for participants with a history of autologous stem cell transplant (ASCT), ASCT was >100 days before initiating study treatment

  • Participant has measurable disease with at least one of the following criteria:

    • Serum M protein >0.5 g/dL (>5 g/L), or
    • Urine M protein >200 mg/24h, or
    • Serum free light chain (FLC) assay: Involved FLC level >5 mg/dL (>50 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65)
  • Participant is quadruple-class exposed or refractory (anti-CD38 antibody (e.g., daratumumab, isatuximab) alone or in combination, immunomodulatory agent (e.g., lenalidomide, pomalidomide), a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib) and BCMA-directed CAR-T cells and/or anti-BCMA bispecific antibodies) and has failed at least 3 prior lines of anti-myeloma therapies
  • Documented presence of BCMA.
  • All prior treatment related toxicities (defined by NCI-CTCAE Version 5.0) must be Grade ≤1 at the time of enrollment, except for alopecia and Grade 2 hematological, hepatic and renal laboratory values.
  • Participant must have adequate organ function at minimum, defined in Table 2 "adequate organ function".
  • Life expectancy of at least 6 months, in the opinion of the investigator
  • Sex and Contraceptive/Barrier Requirements
  • Participants must adhere to contraceptive guidelines on contraception methods in clinical studies to minimize the risk of pregnancy
  • Signed informed consent
  • Participant affiliated to or a beneficiary of a social security category

Exclusion Criteria:

  • Patients under guardianship or curators
  • Patients with insufficient proficiency in French to understand the study information
  • Prior treatment with an anti-BCMA targeted therapy within 90 days of receiving the first dose of study drugs, or treatment with an investigational agent or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or 5 half-lives of receiving the first dose of study drugs.
  • A known intolerance or immediate or delayed hypersensitivity to drugs chemically related to Belantamab mafodontin or Mezigdomide or any of of the components of the study treatment.
  • Prior treatment with an antibody-drug conjugate.
  • Prior treatment with Mezigdomide.
  • Prior allogeneic stem cell transplant.
  • Any major surgery within 4 weeks before the first dose of study drug (or 2 weeks if clinically stable). Additional exception allowed for bone-stabilizing surgery after consultation with medical monitor.
  • Has received a live or attenuated vaccine within 30 days before the first dose of study treatment.
  • Participant has received plasmapheresis ≤ 7 days before the first dose of study treatment.
  • Presence of active renal condition (infection, requirement for dialysis, or any other condition that could affect participant's safety).
  • Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance with the study procedures.
  • Evidence of active mucosal or internal bleeding.
  • Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
  • Evidence of cardiovascular risk.
  • Participant has malignancies other than MM are excluded, except for any other malignancy from which the participant has been disease free for >5 years with the exception of the following noninvasive malignancies: basal or squamous cell skin carcinoma, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological findings of prostate cancer (T1a or T1b using the tumor, nodes, and metastases clinical staging system), or prostate cancer that is curative.
  • Active infection requiring antibiotic, antiviral, or antifungal therapy.
  • Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma-proliferative disorder, skin changes) or active plasma cell leukemia at the time of screening.
  • Current corneal epithelial disease, except mild punctuate keratopathy.
  • Contact lenses are not allowed for participants while they are receiving Belantamab mafodontin treatment. Contact lens use may be restarted after discontinuation of Belantamab mafondontin treatment, provided the eye-care specialist confirms there are no other contraindications.
  • Treatment with strong CYP3A4/5 modulators or Potassium-Competitive Acid Blockers or Proton Pump Inhibitors or unable to absorb oral therapies (i.e. gastric surgery).
  • Participant is a pregnant or lactating female.
  • Participant with known HIV infection is excluded, unless the specific criteria (see relative section) are met.
  • Patient with a presence of hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb) at screening or within 3 months before first dose of study treatment should be excluded, unless the criteria described in the relative section are met.
  • Participant with a positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months before first dose of study treatment are excluded, unless the criteria described in the relative section are met.

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: CAR-T therapy (+/-prior bispecific anti-BCMA treatment too) Patients
Patients previously treated with CAR-T therapy (+/-prior bispecific anti-BCMA treatment too)
Médicament: CAR-T cells
Combination of Belantamab and Mezigdomide treatments with patients previously treated with anti-BCMA CAR-T cells (with or without bispecific antibodies)
Comparateur actif: Only Anti-BCMA treatment patients
Patients treated with prior bispecific anti-BCMA treatment only.
Médicament: BCMA bispecific
Combination of Belantamab and Mezigdomide treatments with patients previously treated with anti-BCMA bispecific antibodies

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Progression Free Survival
Délai: Year 5

Defined as the duration from the start date of treatment to the date of either progressive disease, or death, whichever occurs first.

Progressive disease will be evaluated as defined by 2016 International Myeloma Working Group (IMWG) response criteria, as data permits, and assessed by the investigator.
Year 5

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Overall response rate (ORR)
Délai: Year 5
ORR, defined as CR or VGPR or PR, according to the IMWG criteria at the time of data cutoff
Year 5
Percentage of patients achieving very good partial response (VGPR) or better, complete response (CR), and partial response (PR).
Délai: Year 5
Percentage of VGPR or better, CR, VGPR, PR, Progression Disease defined according to the IMWG criteria at the time of data cutoff
Year 5
Time to response (TTR)
Délai: Year 5
Time to response
Year 5
Duration of response (DOR)
Délai: Year 5
Response duration
Year 5
Overall survival (OS)
Délai: Year 5
OS measured from the date of inclusion to the date of the subject's death. If the subject is alive or the vital status is unknown at last contact, then the subject's data will be censored at the date the subject was last known to be alive.
Year 5
Time to progression (TTP)
Délai: Year 5
TTP defined as time from the start date of treatment to discontinuation of therapy for any reason including death, progression, toxicity.
Year 5
Time to next treatment (TNT)
Délai: Year 5
TNT defined as the time from the start date of treatment to the start of the next-line treatment.
Year 5
Time-to-treatment failure (TTF).
Délai: Year 5
Time-to-treatment failure, defined as time from the start date of treatement to discontinuation of therapy for any reason including death, progression, toxicity.
Year 5
Assessing therapy-related adverse events according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 6.0), particularly ocular events, to understand corneal safety and tolerability.
Délai: Year 5
Assessing therapy-related adverse events according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 6.0), particularly ocular events, to understand corneal safety and tolerability.
Year 5
Evaluating changes in the Ocular Surface Disease Index (OSDI)
Délai: Year 5
Simplified OSDI (Ocular Surface Disease Index). A score of 4 or higher indicates dry eyes
Year 5

Collaborateurs et enquêteurs

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

Parrainer

Centre Hospitalier Universitaire de Saint Etienne

Les enquêteurs

  • Chercheur principal: Emilie CHALAYER, MD, CHU de Saint-Etienne

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 juin 2026

Achèvement primaire (Estimé)

1 janvier 2028

Achèvement de l'étude (Estimé)

1 janvier 2031

Dates d'inscription aux études

Première soumission

29 avril 2026

Première soumission répondant aux critères de contrôle qualité

22 mai 2026

Première publication (Réel)

29 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 24CH294
  • 2025-520976-25-00 (Ctis)

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

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

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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