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NCT07612787PHASE2NOT_YET_RECRUITING

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

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

Sponsor: Centre Hospitalier Universitaire de Saint Etienne

No open prediction endpoints

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Key Facts

Study type
INTERVENTIONAL
Conditions
Myeloma Multiple
Interventions
CAR-T cells, BCMA bispecific
Enrollment
44 participants
Primary completion
Jan 2028
Study completion
Jan 2031
First posted
May 2026
Last updated
May 2026

Primary Endpoints (CT.gov)

Progression Free Survival

Time frame: Year 5

Secondary Endpoints

Overall response rate (ORR)

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

Time to response (TTR)

Eligibility Criteria

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, car

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov