Hypogammaglobulinemia is an immunologic disorder characterized by reduced serum immunoglobulin levels, leading to increased susceptibility to recurrent infections. It may be primary (genetic) or secondary to medications, malignancy, or other conditions. Clinical severity varies with degree of antibody deficiency and associated immune dysfunction.
A systematic review and meta-analysis found high infection rates with teclistamab in relapsed/refractory multiple myeloma. Five studies showed pooled infection rates of 56.5% for any grade and 27.6% for grade 3 or higher.
The FDA approved Tecvayli plus Darzalex Faspro for relapsed or refractory multiple myeloma after at least one prior therapy, and accepted a new drug application for iberdomide plus daratumumab and dexamethasone with a PDUFA date of August 17, 2026.
CAR T-cell therapy is delivering high remission rates for multiple myeloma patients, with improved handoff communication reducing infection risks. FDA-approved BCMA-targeting products show response rates from 72% to 98% in heavily pretreated patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07220915 |
Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections |
NOT_YET_RECRUITING | PHASE3 |
| NCT06976476 |
Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia |
RECRUITING | PHASE2 |
| NCT05678621 |
Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Immunoglobulin Stopping or Extension |
RECRUITING | PHASE2/PHASE3 |
| NCT05645107 |
A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma |
RECRUITING | PHASE3 |
| NCT05357781 |
Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)? |
RECRUITING | |
| NCT04502030 |
Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study) |
COMPLETED | PHASE3 |
| NCT04447937 |
Immunodeficiency in MS |
UNKNOWN | |
| NCT04283747 |
Rituximab-Induced Hypogammaglobulinemia in Multiple Sclerosis |
UNKNOWN | |
| NCT03401268 |
Subcutaneous Ig in Allogeneic Stem Cell Transplant Recipients |
COMPLETED | NA |
| NCT02508584 |
Personalized Immunotherapeutic for Antibiotic-resistant Infection |
COMPLETED | EARLY_PHASE1 |
