Not Yet RecruitingPhase 1/2

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

France44 participantsStarted 2026-06-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 2 trial combining belantamab mafodotin and mezigdomide — can you explain what we already know about the safety of each drug individually, and what new risks might come from combining them that I should be aware of?
2Since this trial is not yet recruiting, how long do you think it might realistically be before I could even enroll, and would waiting that long affect my current treatment options or the progression of my myeloma?
3The trial is measuring progression-free survival as its main goal — does that mean we won't know yet whether this combination actually helps people live longer, and how should that factor into my decision?
4Belantamab mafodotin is known to carry a risk of eye-related side effects — given my specific health history, is that a concern you'd want to monitor closely if I were to consider this trial?
5Given that this is a Phase 2 study for relapsed multiple myeloma, are there standard second-line or third-line treatments I should try first, or does my situation make a trial like this worth discussing as a more immediate path?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression Free Survival

Timeframe: Year 5

Trial details

NCT IDNCT07612787

SponsorCentre Hospitalier Universitaire de Saint Etienne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-01

Contact for this trial

Emilie CHALAYER, MD

(0)4 77 82 28 14 Emilie.Chalayer2@chu-st-etienne.fr

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