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

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

Inclusion Criteria5

  • 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 Criteria2

  • Less than 18 years old
  • Pregancy or breastfeeding

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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