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

NCT07612787 | Not Yet Recruiting Phase 2

• 2 other identifiers: 24CH2942025-520976-25-00
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 30

Brief 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.

Conditions

Myeloma Multiple

Keywords

cancer; hematology; relapse; antibody

Outcome Measures

Primary Outcomes (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.

  Year 5

Secondary Outcomes (10)

• Overall response rate (ORR)

  Year 5

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

  Year 5

• Time to response (TTR)

  Year 5

• Duration of response (DOR)

  Year 5

• Overall survival (OS)

  Year 5

Study Arms (2)

CAR-T therapy (+/-prior bispecific anti-BCMA treatment too) Patients

EXPERIMENTAL

Patients previously treated with CAR-T therapy (+/-prior bispecific anti-BCMA treatment too)

Drug: CAR-T cells

Only Anti-BCMA treatment patients

ACTIVE COMPARATOR

Patients treated with prior bispecific anti-BCMA treatment only.

Drug: BCMA bispecific

Interventions

CAR-T cells DRUG

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

CAR-T therapy (+/-prior bispecific anti-BCMA treatment too) Patients

BCMA bispecific DRUG

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

Only Anti-BCMA treatment patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (30)

Centre Hospitalier Universitaire

Amiens, 80000, France

Location

Centre Hospitalier Universitaire

Angers, 49100, France

Location

Centre Hospitalier Universitaire

Annecy, 74370, France

Location

Centre Hospitalier D'Argenteuil

Argenteuil, 95107, France

Location

Centre Hospitalier de La Cote Basque

Bayonne, 64100, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Centre Hospitalier Universitaire

Brest, 29200, France

Location

Centre Hospitalier Universitaire

Caen, 14008, France

Location

Centre Hospitalier Universitaire

Clermont-Ferrand, 63003, France

Location

Centre Hospitalier Universitaire

Dijon, 21000, France

Location

Centre Hospitalier Universitaire

Grenoble, 38700, France

Location

Centre Hospitalier

Le Mans, 72037, France

Location

Centre Hospitalier Universitaire

Lille, 59000, France

Location

Centre Hospitalier Universitaire

Limoges, 87000, France

Location

HCL Lyon-Sud

Lyon, 69000, France

Location

Centre Hospitalier Regional Et Universitaire

Nancy, 54500, France

Location

Hôpital Privé de Confluent

Nantes, 44000, France

Location

Centre Hospitalier Universitaire

Nantes, 44093, France

Location

Centre Hospitalier Universitaire

Nice, 06000, France

Location

Centre Hospitalier Universitaire

Orléans, 45100, France

Location

Centre Hospitalier Universitaire

Paris, 75010, France

Location

Hopital St Antoine

Paris, 75012, France

Location

APHP - La Pitié Salpétrière

Paris, 75013, France

Location

Hopital Cochin

Paris, 75014, France

Location

Centre Hospitalier de Poitiers

Poitiers, 86000, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre Hospitalier Universitaire

Saint-Etienne, 42055, France

Location

ICANS

Strasbourg, 67200, France

Location

IUCT

Toulouse, 31100, France

Location

Centre Hospitalier Universitaire

Tours, 37000, France

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms; Recurrence

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Emilie CHALAYER, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie CHALAYER, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2031
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

FR (30)