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

11 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

44

Fase

  • Fase 2
  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Francia
      • Amiens, Francia, 80000
        • Centre Hospitalier Universitaire
        • Contacto:
      • Angers, Francia, 49100
        • Centre Hospitalier Universitaire
        • Contacto:
          • Mamoun DIB, MD
          • Número de teléfono: +33 (0)2 41 35 36 37
      • Annecy, Francia, 74370
        • Centre Hospitalier Universitaire
        • Contacto:
          • Frédérique ORSINI-PIOCELLE, MD
          • Número de teléfono: +33 (0)4 50 63 63 63
      • Argenteuil, Francia, 95107
        • Centre Hospitalier d'Argenteuil
        • Contacto:
          • EMMANUELLE LE RAY, MD
          • Número de teléfono: +33 (0)1 34 23 24 25
      • Bayonne, Francia, 64100
        • Centre Hospitalier de la Côte Basque
        • Contacto:
          • Julie GAY, MD
          • Número de teléfono: +33 (0)559443535
      • Bordeaux, Francia, 33076
        • Institut Bergonie
        • Contacto:
          • Anna SCHMITT, MD
          • Número de teléfono: +33 (0)5 56 33 33 33
      • Brest, Francia, 29200
      • Caen, Francia, 14008
        • Centre Hospitalier Universitaire
        • Contacto:
          • Margaret MACRO, MD
          • Número de teléfono: +33 (0)231063106
      • Clermont-Ferrand, Francia, 63003
        • Centre Hospitalier Universitaire
        • Contacto:
          • Carolyne CROIZIER, MD
          • Número de teléfono: +33 (0)4 73 750 750
      • Dijon, Francia, 21000
        • Centre Hospitalier Universitaire
        • Contacto:
          • Andréa PIERAGOSTINI, MD
          • Número de teléfono: +33 (0)380293031
      • Grenoble, Francia, 38700
        • Centre Hospitalier Universitaire
        • Contacto:
          • Clara MARIETTE, MD
          • Número de teléfono: +33 (0)476767575
      • Le Mans, Francia, 72037
        • Centre Hospitalier
        • Contacto:
          • Kamel LARIBI, MD
          • Número de teléfono: +33 (0)2 43 43 43 43
      • Lille, Francia, 59000
        • Centre Hospitalier Universitaire
        • Contacto:
      • Limoges, Francia, 87000
        • Centre Hospitalier Universitaire
        • Contacto:
          • Murielle ROUSSEL, MD
          • Número de teléfono: +33 (0)5 55 05 55 55
      • Lyon, Francia, 69000
        • HCL Lyon-Sud
        • Contacto:
      • Nancy, Francia, 54500
        • Centre Hospitalier Regional Et Universitaire
        • Contacto:
          • Caroline JACQUET, MD
          • Número de teléfono: +33 (0)3 83 85 85 85
      • Nantes, Francia, 44093
        • Centre Hospitalier Universitaire
        • Contacto:
      • Nantes, Francia, 44000
      • Nice, Francia, 06000
        • Centre Hospitalier Universitaire
        • Contacto:
          • Thomas CLUZEAU, PHD
          • Número de teléfono: +33 (0)4 92 03 58 93
          • Correo electrónico: cluzeau.t@chu-nice.fr
      • Orléans, Francia, 45100
        • Centre Hospitalier Universitaire
        • Contacto:
          • Marlène OCHMANN, MD
          • Número de teléfono: +33 (0)2 38 51 44 44
      • Paris, Francia, 75013
        • APHP - La Pitié Salpétrière
        • Contacto:
      • Paris, Francia, 75014
        • Hôpital Cochin
        • Contacto:
          • Marguerite VIGNON, MD
          • Número de teléfono: +33 (0)158414141
      • Paris, Francia, 75012
        • Hôpital St Antoine
        • Contacto:
          • Mohamad MOTHY, MD
          • Número de teléfono: +33 (0)1 49 28 20 00
      • Paris, Francia, 75010
        • Centre Hospitalier Universitaire
        • Contacto:
          • Bertrand ARNULF, PHD
          • Número de teléfono: +33 (0)1 42 49 49 49
      • Poitiers, Francia, 86000
        • Centre Hospitalier de Poitiers
        • Contacto:
          • Arthur BOBIN, MD
          • Número de teléfono: +33 (0)5 49 44 44 44
      • Rouen, Francia, 76038
        • Centre Henri Becquerel
        • Contacto:
          • Pascal LENAIN, MD
          • Número de teléfono: +33 (0)2 32 08 22 22
      • Saint-Etienne, Francia, 42055
      • Strasbourg, Francia, 67200
        • ICANS
        • Contacto:
          • Céline SONNTAG, MD
          • Número de teléfono: +33 (0)3 68 76 65 65
      • Toulouse, Francia, 31100
        • IUCT
        • Contacto:
          • Aurore PERROT, PHD
      • Tours, Francia, 37000
        • Centre Hospitalier Universitaire
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: CAR-T therapy (+/-prior bispecific anti-BCMA treatment too) Patients
Patients previously treated with CAR-T therapy (+/-prior bispecific anti-BCMA treatment too)
Droga: CAR-T cells
Combination of Belantamab and Mezigdomide treatments with patients previously treated with anti-BCMA CAR-T cells (with or without bispecific antibodies)
Comparador activo: Only Anti-BCMA treatment patients
Patients treated with prior bispecific anti-BCMA treatment only.
Droga: BCMA bispecific
Combination of Belantamab and Mezigdomide treatments with patients previously treated with anti-BCMA bispecific antibodies

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression Free Survival
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall response rate (ORR)
Periodo de tiempo: 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).
Periodo de tiempo: 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)
Periodo de tiempo: Year 5
Time to response
Year 5
Duration of response (DOR)
Periodo de tiempo: Year 5
Response duration
Year 5
Overall survival (OS)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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).
Periodo de tiempo: 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.
Periodo de tiempo: 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)
Periodo de tiempo: Year 5
Simplified OSDI (Ocular Surface Disease Index). A score of 4 or higher indicates dry eyes
Year 5

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Centre Hospitalier Universitaire de Saint Etienne

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de enero de 2028

Finalización del estudio (Estimado)

1 de enero de 2031

Fechas de registro del estudio

Enviado por primera vez

29 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de mayo de 2026

Publicado por primera vez (Actual)

29 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

11 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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