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

11. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

44

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: CAR-T therapy (+/-prior bispecific anti-BCMA treatment too) Patients
Patients previously treated with CAR-T therapy (+/-prior bispecific anti-BCMA treatment too)
Legemiddel: CAR-T cells
Combination of Belantamab and Mezigdomide treatments with patients previously treated with anti-BCMA CAR-T cells (with or without bispecific antibodies)
Aktiv komparator: Only Anti-BCMA treatment patients
Patients treated with prior bispecific anti-BCMA treatment only.
Legemiddel: BCMA bispecific
Combination of Belantamab and Mezigdomide treatments with patients previously treated with anti-BCMA bispecific antibodies

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression Free Survival
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall response rate (ORR)
Tidsramme: 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).
Tidsramme: 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)
Tidsramme: Year 5
Time to response
Year 5
Duration of response (DOR)
Tidsramme: Year 5
Response duration
Year 5
Overall survival (OS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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).
Tidsramme: 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.
Tidsramme: 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)
Tidsramme: Year 5
Simplified OSDI (Ocular Surface Disease Index). A score of 4 or higher indicates dry eyes
Year 5

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Etterforskere

  • Hovedetterforsker: Emilie CHALAYER, MD, CHU de Saint-Etienne

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. januar 2028

Studiet fullført (Antatt)

1. januar 2031

Datoer for studieregistrering

Først innsendt

29. april 2026

Først innsendt som oppfylte QC-kriteriene

22. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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