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RECRUITING
NCT07094048
PHASE4

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

Sponsor: CHU de Quebec-Universite Laval

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-01-05

Completion Date

2029-12

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

DRUG

Target trough IgG level of 8-10 g/L

Target trough IgG level of 8-10 g/L

DRUG

Target trough IgG level 4-6 g/L

Target trough IgG level of 4-6 g/L

DRUG

No 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