Immunoglobulins in Multiple Myeloma Patients Receiving a BCMA-Directed T Cell Engager
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCHU de Quebec-Universite Laval
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
≥ 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
Disqualifiers
Less than 18 years old
Pregancy or breastfeeding
Trial design
Design model
Parallel
Treatments tested in this trial
Target trough IgG level of 8-10 g/L
DrugTarget trough IgG level of 8-10 g/L
Target trough IgG level 4-6 g/L
DrugTarget 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
DrugIf, 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
Treatment groups
80 Participants
are divided into 3 treatment groupsGroup A: Group A IgG level 8-10 g/LActive comparator 1 intervention
Group B: Group B IgG level 4-6 g/LExperimental treatment 1 intervention
Group C: Group COther 1 intervention
Trial outcomes
Primary outcomes
1
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 randomizationSecondary outcomes
1
Minor/Moderate infections rate
Rates of minor/moderate infection rates
Time frame
From enrollment to 12 monts after randomization2
All infection rate
All infections rate
Time frame
From enrollment to 12 months after randomizationOther outcomes
1
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.2
CM reactivation and infection rate
CMV reactivation and infection
Time frame
From enrollment to 12 months after randomization3
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 randomization4
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 randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov