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

May 22, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAR-T therapy (+/-prior bispecific anti-BCMA treatment too) Patients
Patients previously treated with CAR-T therapy (+/-prior bispecific anti-BCMA treatment too)
Drug: CAR-T cells
Combination of Belantamab and Mezigdomide treatments with patients previously treated with anti-BCMA CAR-T cells (with or without bispecific antibodies)
Active Comparator: Only Anti-BCMA treatment patients
Patients treated with prior bispecific anti-BCMA treatment only.
Drug: BCMA bispecific
Combination of Belantamab and Mezigdomide treatments with patients previously treated with anti-BCMA bispecific antibodies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: 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).
Time Frame: 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)
Time Frame: Year 5
Time to response
Year 5
Duration of response (DOR)
Time Frame: Year 5
Response duration
Year 5
Overall survival (OS)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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).
Time Frame: 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.
Time Frame: 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)
Time Frame: Year 5
Simplified OSDI (Ocular Surface Disease Index)
Year 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Emilie CHALAYER, MD, CHU de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

April 29, 2026

First Submitted That Met QC Criteria

May 22, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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