A Phase 4 interventional study of Target trough IgG level of 8-10 g/L and Target trough IgG level 4-6 g/L in Multiple Myeloma Refractory and Relapsed Multiple Myeloma, sponsored by CHU de Quebec-Universite Laval. Recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by CHU de Quebec-Universite Laval · Phase 4, Interventional, and Treatment
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.
Although the effectiveness of immunoglobulins (Ig) has been demonstrated, it remains to be determined whether immunoglobulin administration is necessary for all patients receiving these therapies or only for those with low serum immunoglobulin G (IgG) levels. Furthermore, the optimal target IgG level to achieve in order to reduce the risk of infections is also unknown in this specific population of multiple myeloma patients. Guidance needs to be provided to the clinicians to better support MM patients undergoing this novel therapy by addressing the hypogammaglobulinemia and therefore limiting and ideally avoiding the high risk of infections.
In this prospective, randomized, unblinded, multicenter study, as per the standard of care approach, every patient with relapsed refractory MM receiving a BCMA-directed TCE with history of recurrent or severe infections and/or total IgG level less than 4 g/L will receive Ig support (intravenous ou subcutaneous). Once on Ig supplementation, the optimal target trough IgG level to achieve is not well established. The goal of this study is therefore to better define, in this patient population , the target trough IgG level to achieve a reduction in the incidence of severe infections.
The primary objective is to demonstrate the 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 (SOC) group).
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 80 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →CHU de Quebec-Universite Laval is the lead sponsor of 137 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunoglobulin support (subcutaneous or intravenous)
Drug: Target trough IgG level of 8-10 g/L
Immunglobulin support (subcutaneous or intravenous)
Drug: Target trough IgG level 4-6 g/L
No immunoglobulin support. If pre specified conditions are met, crossover to Group A or B.
Drug: No history of recurrent or severe infections and total IgG level higher or equal at 4 g/L
Target trough IgG level of 8-10 g/L
Also known as: Standard of care
Target trough IgG level of 4-6 g/L
Also known as: Experimental
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
Also known as: Crossover
Severe infections
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)
Time frame: From enrollment to 3 months after time of randomization
Minor/Moderate infections rate
Rates of minor/moderate infection rates
Time frame: From enrollment to 12 monts after randomization
All infection rate
All infections rate
Time frame: From enrollment to 12 months after randomization
Vaccinal response (optional)
For patients with no previous Ig support, we will examine the vaccinal response with specific antibody titers to tetanus.
Time frame: From vaccination (at enrollment) to 1 month after vaccination.
CM reactivation and infection rate
CMV reactivation and infection
Time frame: From enrollment to 12 months after randomization
Adverse events related to the administration of the Ig product
Adverse events related to the administration of the Ig product
Time frame: From enrollment to 12 months after randomization
Quality of life assessment, according to the EORTC-QLQ-C30
Quality of life assessment (SC and IV)
Time frame: From enrollment to 12 months after randomization
Plan to share: Undecided
Started Jan 2026 (actual). Primary completion is estimated for Dec 2028, 35 months after the start.
Of 28 phase 4 interventional studies under Multiple Myeloma, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 57. This study's planned 35 months is below that.
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