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

22. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

44

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CAR-T therapy (+/-prior bispecific anti-BCMA treatment too) Patients
Patients previously treated with CAR-T therapy (+/-prior bispecific anti-BCMA treatment too)
Medicin: 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.
Medicin: BCMA bispecific
Combination of Belantamab and Mezigdomide treatments with patients previously treated with anti-BCMA bispecific antibodies

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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)
Year 5

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Efterforskere

  • Ledende efterforsker: Emilie CHALAYER, MD, Chu de Saint-Etienne

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. januar 2028

Studieafslutning (Anslået)

1. januar 2031

Datoer for studieregistrering

Først indsendt

29. april 2026

Først indsendt, der opfyldte QC-kriterier

22. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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