이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 6월 11일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

44

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: CAR-T therapy (+/-prior bispecific anti-BCMA treatment too) Patients
Patients previously treated with CAR-T therapy (+/-prior bispecific anti-BCMA treatment too)
의약품: CAR-T cells
Combination of Belantamab and Mezigdomide treatments with patients previously treated with anti-BCMA CAR-T cells (with or without bispecific antibodies)
활성 비교기: Only Anti-BCMA treatment patients
Patients treated with prior bispecific anti-BCMA treatment only.
의약품: BCMA bispecific
Combination of Belantamab and Mezigdomide treatments with patients previously treated with anti-BCMA bispecific antibodies

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression Free Survival
기간: 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

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Centre Hospitalier Universitaire de Saint Etienne

수사관

  • 수석 연구원: Emilie CHALAYER, MD, CHU de Saint-Etienne

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2028년 1월 1일

연구 완료 (추정된)

2031년 1월 1일

연구 등록 날짜

최초 제출

2026년 4월 29일

QC 기준을 충족하는 최초 제출

2026년 5월 22일

처음 게시됨 (실제)

2026년 5월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 11일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다