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RecruitingPhase 4NCT07094048

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

Sponsor

CHU de Quebec-Universite Laval

Enrollment

80 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma, RefractoryRelapsed Multiple Myeloma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the use of intravenous immunoglobulins (IVIG — a treatment that boosts the immune system using antibodies from donated blood) in people with multiple myeloma who are receiving a new type of treatment called a BCMA-directed T-cell engager (a drug that directs the immune system to attack myeloma cells). Myeloma and its treatments can weaken the immune system, and researchers want to know if IVIG helps prevent infections in these patients. **You may be eligible if...** - You are 18 years or older - You have multiple myeloma and have received at least one prior line of treatment - You are currently starting or already receiving a BCMA-directed T-cell engager therapy **You may NOT be eligible if...** - You are under 18 years old - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTarget trough IgG level of 8-10 g/L

Target trough IgG level of 8-10 g/L

DRUGTarget trough IgG level 4-6 g/L

Target trough IgG level of 4-6 g/L

DRUGNo history of recurrent or severe infections and total IgG level higher or equal at 4 g/L

If, during follow-up, the patient presents recurrent or severe infections and/or total IgG level less 4 g/L, crossover to group A or B

Locations(1)

Centre Intégré de Cancérologie

Québec, Quebec, Canada

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NCT07094048

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