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An Open-label, Multi-Center, Single-arm Prospective Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex®-C plus Standard Medical Treatment to Prevent Infections in Participants with Secondary Antibody Deficiency Associated with Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma (Sigma).

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526803-31-00
Enrollment
31
Registered
2026-09-14
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma, or Non-Hodgkin Lymphoma, Secondary Antibody Deficiency Associated with Chronic Lymphocytic Leukemia

Brief summary

SBI rate per-participant per year.

Detailed description

Time to first onset of SBI., Time to first onset of severe bacterial infection., Proportion of participants who experience at least one severe bacterial infection., The rate of severe bacterial infections per participant per year, The rate of all bacterial infections per participant per year, Time to first onset of non-severe bacterial infection, The proportion of participants who experience at least one bacterial infection, The rate of infections of any kind (bacterial/viral/fungal, irrespective of severity or seriousness) per participant per year, Time to first onset of any kind of infection (bacterial/viral/fungal)., The proportion of participants who experience a validated infection., The rate of validated (as defined above) infections per participant per year, Number of days on prophylactic antibiotics (including oral, parenteral, oral plus parenteral)., The number of days on prophylactic antibiotics per participant per year, Number of days on therapeutic antibiotics (including oral, parenteral, oral plus parenteral)., The number of days on therapeutic antibiotics per participant per year, Number of hospitalizations and total duration of hospitalizations due to any infections., The rate of hospitalizations per participant per year due to any infections, Rate of infections requiring IV administration of an antibiotic or antiviral/anti-infective per-participant per year.

Interventions

Sponsors

Grifols Therapeutics LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
SBI rate per-participant per year.

Secondary

MeasureTime frame
Time to first onset of SBI., Time to first onset of severe bacterial infection., Proportion of participants who experience at least one severe bacterial infection., The rate of severe bacterial infections per participant per year, The rate of all bacterial infections per participant per year, Time to first onset of non-severe bacterial infection, The proportion of participants who experience at least one bacterial infection, The rate of infections of any kind (bacterial/viral/fungal, irrespective of severity or seriousness) per participant per year, Time to first onset of any kind of infection (bacterial/viral/fungal)., The proportion of participants who experience a validated infection., The rate of validated (as defined above) infections per participant per year, Number of days on prophylactic antibiotics (including oral, parenteral, oral plus parenteral)., The number of days on prophylactic antibiotics per participant per year, Number of days on therapeutic antibiotics (including or

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 16, 2026