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

Condition(s) studied

Investigational drug(s) / intervention(s)

Target trough IgG level of 8-10 g/L: Target trough IgG level of 8-10 g/L

Target trough IgG level 4-6 g/L: Target trough IgG level of 4-6 g/L

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

Study 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

Primary outcome measure(s)

• Severe infections — From enrollment to 3 months after time of randomization
  Non-inferiority in the cumulative incidence of severe infections at 3 months between patients on Ig support with a target trough IgG level of 4-6 g/L (experimental group) versus a target trough IgG level of 8-10 g/L (standard of care group)

Trial sites (2)

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