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Recruiting Phase 4 NCT07094048

Immunoglobulins in Multiple Myeloma Patients Receiving a BCMA-Directed T Cell Engager

Trial Parameters

Condition Multiple Myeloma Refractory
Sponsor CHU de Quebec-Universite Laval
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 80
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-01-05
Completion 2028-12
Interventions
Target trough IgG level of 8-10 g/LTarget trough IgG level 4-6 g/LNo history of recurrent or severe infections and total IgG level higher or equal at 4 g/L

Brief Summary

Bispecific antibody therapies targeting BCMA (B-cell maturation antigen) represent a novel therapeutic approach for patients with multiple myeloma. They are currently used in cases of refractory multiple myeloma but are also being investigated in earlier lines of treatment. However, these new therapies can lead to deeper immunosuppression and exacerbate an underlying immunosuppressive state in patients with multiple myeloma. As a result, infectious complications are common with these therapies and are a significant concern. Therefore, preventing infections in this population is crucial. However, data on the best strategies for prevention are currently lacking.

Eligibility Criteria

Inclusion Criteria: * Multiple myeloma patient: * ≥ 18 years old * ≥ 1 prior lines of therapy * Receiving a BCMA-directed T-cell Engager therapy (starting on treatment) * On previous Ig support or not Exclusion Criteria: * Less than 18 years old * Pregancy or breastfeeding

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