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

22 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

44

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Subjects who are ≥ 18 years of age
  2. Participant has a histologically or cytologically confirmed diagnosis of MM as defined by IMWG criteria
  3. Participant has Eastern Cooperative Oncology Group (ECOG) performance status of score of 0, 1, or 2
  4. 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

  5. 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)
  6. 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
  7. Documented presence of BCMA.

  8. 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".

  9. Life expectancy of at least 6 months, in the opinion of the investigator
  10. Sex and Contraceptive/Barrier Requirements
  11. Participants must adhere to contraceptive guidelines on contraception methods in clinical studies to minimize the risk of pregnancy
  12. Signed informed consent
  13. Participant affiliated to or a beneficiary of a social security category

Exclusion Criteria:

Patients under guardianship or curators 2. Patients with insufficient proficiency in French to understand the study information 3. 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.

5. Prior treatment with an antibody-drug conjugate. 6. Prior treatment with Mezigdomide. 7. Prior allogeneic stem cell transplant. 8. 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.

9. Has received a live or attenuated vaccine within 30 days before the first dose of study treatment.

10. Participant has received plasmapheresis ≤ 7 days before the first dose of study treatment.

11. Presence of active renal condition (infection, requirement for dialysis, or any other condition that could affect participant's safety).

12. 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.

13. Evidence of active mucosal or internal bleeding. 14. 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.

15. Evidence of cardiovascular risk. 16. 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.

17. Active infection requiring antibiotic, antiviral, or antifungal therapy. 18. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma-proliferative disorder, skin changes) or active plasma cell leukemia at the time of screening.

19. Current corneal epithelial disease, except mild punctuate keratopathy. 20. 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.

21. 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).

22.Participant is a pregnant or lactating female. 23. Participant with known HIV infection is excluded, unless the specific criteria (see relative section) are met.

24. 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.

25. 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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)
Comparatore attivo: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression Free Survival
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall response rate (ORR)
Lasso di tempo: 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).
Lasso di tempo: 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)
Lasso di tempo: Year 5
Time to response
Year 5
Duration of response (DOR)
Lasso di tempo: Year 5
Response duration
Year 5
Overall survival (OS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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).
Lasso di tempo: 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.
Lasso di tempo: 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)
Lasso di tempo: Year 5
Simplified OSDI (Ocular Surface Disease Index)
Year 5

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigatori

  • Investigatore principale: Emilie CHALAYER, MD, CHU de Saint-Etienne

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 gennaio 2028

Completamento dello studio (Stimato)

1 gennaio 2031

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

22 maggio 2026

Primo Inserito (Effettivo)

29 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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