Target IgG levels for people with multiple myeloma on BCMA-directed T-cell engager therapy
Official title: Immunoglobulins in Multiple Myeloma Patients Receiving a BCMA-Directed T Cell Engager
Run by CHU de Quebec-Universite Laval · NCT07094048 · Data updated 2026-11-12
This will test whether keeping IgG levels at 4–6 g/L works as well as 8–10 g/L to prevent severe infections in adults with relapsed or refractory multiple myeloma who are receiving BCMA-directed T-cell engager therapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | CHU de Quebec-Universite Laval Academic / other |
| Locations | 2 sites (Lévis, Quebec and 1 other locations) |
| Status | Recruiting |
| Started | January 5, 2026 |
| Main results expected | December 2028 |
| Study ends | December 2029 |
| Registry record updated | July 22, 2026 |
| Trial ID | NCT07094048 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with relapsed or refractory multiple myeloma starting BCMA-directed T-cell engager therapy who need or are candidates for Ig replacement due to recurrent/severe infections or IgG <4 g/L are the intended participants.
✕Probably not a fit
Patients not receiving BCMA-directed T-cell engager therapy, those without low IgG or recurrent infections, and pregnant or breastfeeding individuals are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, unblinded, multicenter comparison of two target trough IgG levels in adults with relapsed or refractory multiple myeloma receiving BCMA-directed T-cell engager therapy. Patients who require immunoglobulin support because of recurrent or severe infections and/or an IgG level below 4 g/L are placed on Ig replacement (IV or subcutaneous) and randomized to a target trough IgG of 4–6 g/L versus 8–10 g/L. The primary endpoint is non-inferiority in the cumulative incidence of severe infections at three months. Results aim to define an optimal IgG trough target to guide clinicians and reduce infection risk in this immunosuppressed population.
Why it matters
Potential benefit: If successful, the approach could lower severe infection rates while optimizing immunoglobulin use and reducing unnecessary infusions and costs.
How similar studies have gone: Immunoglobulin replacement has previously reduced infections in multiple myeloma generally, but the optimal trough IgG target specifically during BCMA-directed T-cell engager therapy has not been established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Less than 18 years old * Pregancy or breastfeeding
Where it's running
-
Santé Québec Chaudière-Appalaches
Lévis, Quebec, Canada Recruiting -
Centre Intégré de Cancérologie
Québec, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Dr Julie Côté, MD,FRCPC — CHU de Québec-Université Laval
- Study coordinator: Philippe Nadeau, PhD
- Email: philippe.nadeau@chudequebec.ca
- Phone: 1-418-525-4444
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.