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Myeloma MultiplePhase 1/2BELAMINCT07612787

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

A Phase 1/2 study testing CAR-T cells and BCMA bispecific in people with Myeloma Multiple, run by Centre Hospitalier Universitaire de Saint Etienne at 30 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myeloma Multiple
What is being tested?
CAR-T cells and BCMA bispecific
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
30 sitesFrance
Study dates
1 Dec 2026to 1 Jan 2031
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

30 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Emilie CHALAYER, MD contact

(0)4 77 82 28 14 ext. +33

Emilie.Chalayer2@chu-st-etienne.fr

30 sites in 1 country

France30 sites

  • Centre Hospitalier Universitaire

    Amiens, 80000

    Lydia MONTES, MD, (0)3 22 45 59 14 ext. +33, montes.lydia@chu-amiens.fr

  • Centre Hospitalier Universitaire

    Angers, 49100

    Mamoun DIB, MD, (0)2 41 35 36 37 ext. +33

  • Centre Hospitalier Universitaire

    Annecy, 74370

    Frédérique ORSINI-PIOCELLE, MD, (0)4 50 63 63 63 ext. +33

  • Centre Hospitalier D'Argenteuil

    Argenteuil, 95107

    EMMANUELLE LE RAY, MD, (0)1 34 23 24 25 ext. +33

  • Centre Hospitalier de La Cote Basque

    Bayonne, 64100

    Julie GAY, MD, (0)559443535 ext. +33

  • Institut Bergonié

    Bordeaux, 33076

    Anna SCHMITT, MD, (0)5 56 33 33 33 ext. +33

  • Centre Hospitalier Universitaire

    Brest, 29200

    Jean-Richard EVEILLARD, MD, (0)2 98 22 34 21 ext. +33, Jean-richard.eveillard@chu-brest.fr

  • Centre Hospitalier Universitaire

    Caen, 14008

    Margaret MACRO, MD, (0)231063106 ext. +33

  • Centre Hospitalier Universitaire

    Clermont-Ferrand, 63003

    Carolyne CROIZIER, MD, (0)4 73 750 750 ext. +33

  • Centre Hospitalier Universitaire

    Dijon, 21000

    Andréa PIERAGOSTINI, MD, (0)380293031 ext. +33

  • Centre Hospitalier Universitaire

    Grenoble, 38700

    Clara MARIETTE, MD, (0)476767575 ext. +33

  • Centre Hospitalier

    Le Mans, 72037

    Kamel LARIBI, MD, (0)2 43 43 43 43 ext. +33

  • Centre Hospitalier Universitaire

    Lille, 59000

    Salomon MANIER, PHD, (0)3 20 44 42 92 ext. +33, salomon.manier@chru-lille.fr

  • Centre Hospitalier Universitaire

    Limoges, 87000

    Murielle ROUSSEL, MD, (0)5 55 05 55 55 ext. +33

  • HCL Lyon-Sud

    Lyon, 69000

    Lionel KARLIN, MD, (0)4 78 86 43 09 ext. +33, Lionel.karlin@chu-lyon.fr

  • Centre Hospitalier Regional Et Universitaire

    Nancy, 54500

    Caroline JACQUET, MD, (0)3 83 85 85 85 ext. +33

  • Hôpital Privé de Confluent

    Nantes, 44000

    Jacques DELAUNAY, MD, (0)2 28 27 21 16 ext. +33, jacques.delaunay@groupeconfluent.fr

  • Centre Hospitalier Universitaire

    Nantes, 44093

    Cyrille TOUZEAU, PHD, (0)2 40 08 32 71 ext. +33, cyrille.touzeau@chu-nantes.fr

  • Centre Hospitalier Universitaire

    Nice, 06000

    Thomas CLUZEAU, PHD, (0)4 92 03 58 93 ext. +33, cluzeau.t@chu-nice.fr

  • Centre Hospitalier Universitaire

    Orléans, 45100

    Marlène OCHMANN, MD, (0)2 38 51 44 44 ext. +33

  • Centre Hospitalier Universitaire

    Paris, 75010

    Bertrand ARNULF, PHD, (0)1 42 49 49 49 ext. +33

  • Hopital St Antoine

    Paris, 75012

    Mohamad MOTHY, MD, (0)1 49 28 20 00 ext. +33

  • APHP - La Pitié Salpétrière

    Paris, 75013

    Laurent GARDERET, MD, (0)1 42 16 27 94 ext. +33, laurent.garderet@aphp.fr

  • Hopital Cochin

    Paris, 75014

    Marguerite VIGNON, MD, (0)158414141 ext. +33

  • Centre Hospitalier de Poitiers

    Poitiers, 86000

    Arthur BOBIN, MD, (0)5 49 44 44 44 ext. +33

  • Centre Henri Becquerel

    Rouen, 76038

    Pascal LENAIN, MD, (0)2 32 08 22 22 ext. +33

  • Centre Hospitalier Universitaire

    Saint-Etienne, 42055

    Emilie CHALAYER, MD, (0)4 77 82 28 14 ext. +33, Emilie.Chalayer2@chu-st-etienne.fr

  • ICANS

    Strasbourg, 67200

    Céline SONNTAG, MD, (0)3 68 76 65 65 ext. +33

  • IUCT

    Toulouse, 31100

    Aurore PERROT, PHD

  • Centre Hospitalier Universitaire

    Tours, 37000

    Thomas CHALOPIN, MD, (0)2 47 47 37 12 ext. +33, t.chalopin@chu-tours.fr

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
CAR-T cells, BCMA bispecific
Keywords
cancer, hematology, relapse, antibody
Medical subject headings
Multiple Myeloma, Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAR-T cellsDrug

    Combination of Belantamab and Mezigdomide treatments with patients previously treated with anti-BCMA CAR-T cells (with or without bispecific antibodies)

  • BCMA bispecificDrug

    Combination of Belantamab and Mezigdomide treatments with patients previously treated with anti-BCMA bispecific antibodies

Study groups in NCT07612787
Study groupRoleWhat they receive
CAR-T therapy (+/-prior bispecific anti-BCMA treatment too) PatientsExperimentalPatients previously treated with CAR-T therapy (+/-prior bispecific anti-BCMA treatment too)
Receives: Drug: CAR-T cells
Only Anti-BCMA treatment patientsActive comparatorPatients treated with prior bispecific anti-BCMA treatment only.
Receives: Drug: BCMA bispecific

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    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.

    Measured: Year 5

Secondary outcomes (10)

  1. Overall response rate (ORR)

    ORR, defined as CR or VGPR or PR, according to the IMWG criteria at the time of data cutoff

    Measured: Year 5

  2. Percentage of patients achieving very good partial response (VGPR) or better, complete response (CR), and partial response (PR).

    Percentage of VGPR or better, CR, VGPR, PR, Progression Disease defined according to the IMWG criteria at the time of data cutoff

    Measured: Year 5

  3. Time to response (TTR)

    Time to response

    Measured: Year 5

  4. Duration of response (DOR)

    Response duration

    Measured: Year 5

  5. Overall survival (OS)

    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.

    Measured: Year 5

  6. Time to progression (TTP)

    TTP defined as time from the start date of treatment to discontinuation of therapy for any reason including death, progression, toxicity.

    Measured: Year 5

  7. Time to next treatment (TNT)

    TNT defined as the time from the start date of treatment to the start of the next-line treatment.

    Measured: Year 5

  8. Time-to-treatment failure (TTF).

    Time-to-treatment failure, defined as time from the start date of treatement to discontinuation of therapy for any reason including death, progression, toxicity.

    Measured: Year 5

  9. 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.

    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.

    Measured: Year 5

  10. Evaluating changes in the Ocular Surface Disease Index (OSDI)

    Simplified OSDI (Ocular Surface Disease Index). A score of 4 or higher indicates dry eyes

    Measured: Year 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Jan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase Ib/II, multicenter, open-label, parallel-group study conducted in patients with relapsed multiple myeloma after treatment with anti-BCMA bispecific antibodies and/or CAR-T cells. A minimum wash-out period of 3 months is required between the last anti-BCMA treatment and inclusion in the BELAMI study. The study includes a Phase Ib safety run-in to confirm the tolerability of the treatment combination before expanding enrollment to the full Phase II cohort.
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07612787
Sponsor's protocol ID
24CH294
Other IDs
2025-520976-25-00, 2025
Acronym
BELAMI
Status last verified
Oct 2026
First submitted
29 Apr 2026
Last updated
9 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CAR-T cells and BCMA bispecific in people with Myeloma Multiple, run by Centre Hospitalier Universitaire de Saint Etienne at 30 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emilie CHALAYER, MD ((0)4 77 82 28 14 ext. +33, Emilie.Chalayer2@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: Year 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07612787.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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