此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2026年6月11日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

44

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：CAR-T therapy (+/-prior bispecific anti-BCMA treatment too) Patients
Patients previously treated with CAR-T therapy (+/-prior bispecific anti-BCMA treatment too)
药品：CAR-T cells
Combination of Belantamab and Mezigdomide treatments with patients previously treated with anti-BCMA CAR-T cells (with or without bispecific antibodies)
有源比较器：Only Anti-BCMA treatment patients
Patients treated with prior bispecific anti-BCMA treatment only.
药品：BCMA bispecific
Combination of Belantamab and Mezigdomide treatments with patients previously treated with anti-BCMA bispecific antibodies

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Progression Free Survival
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Overall response rate (ORR)
大体时间：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).
大体时间：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)
大体时间：Year 5
Time to response
Year 5
Duration of response (DOR)
大体时间：Year 5
Response duration
Year 5
Overall survival (OS)
大体时间：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)
大体时间：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)
大体时间：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).
大体时间：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.
大体时间：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)
大体时间：Year 5
Simplified OSDI (Ocular Surface Disease Index). A score of 4 or higher indicates dry eyes
Year 5

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Centre Hospitalier Universitaire de Saint Etienne

调查人员

  • 首席研究员：Emilie CHALAYER, MD、CHU de Saint-Etienne

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2028年1月1日

研究完成 (估计的)

2031年1月1日

研究注册日期

首次提交

2026年4月29日

首先提交符合 QC 标准的

2026年5月22日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年6月15日

上次提交的符合 QC 标准的更新

2026年6月11日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 24CH294
  • 2025-520976-25-00 (克蒂斯)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅