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

NCT07094048 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-07

No results posted yet for this 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.

Conditions

  • Multiple Myeloma Refractory
  • Relapsed Multiple Myeloma

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

Sponsors & Collaborators

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Dr Julie Côté, MD,FRCPC · CHU de Québec-Université Laval

  • Dr Julie Côté, MD,FRCPC · CHU de Québec-Université Laval

  • Dr Vincent Laroche, MD,FRCPC · CHU de Québec-Université Laval

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07094048 on ClinicalTrials.gov