Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia
Study Phase: Phase 2
Recruitment Status: Recruiting
Start Date: May 08, 2025
End Date: May 08, 2029
Inclusion Criteria:
- Diagnosis of RRMM receiving a commercially available bispecific antibody
- Received at least 1 but no more than 4 cycles of BsAb
- Received 2 or more lines of therapy for MM IgG ≤ 4 g/L excluding paraprotein. For IgG Kappa MM, hypogammaglobulinemia will be determined by subtracting the M spike from IgG
- Males or females greater than or equal to 18 years old at the time of consent
- ECOG ≤ 3
- Life expectancy > 12 months
Exclusion Criteria:
- HSCT within 3 months before enrollment
- Planned CAR-T therapy in the next 6 months
- >1 major (deep-seated) infection within the preceding 3 months
- HIV infection, Active HCV, or Active HBV infection
- Pregnancy
- Neutrophils < 500 x 10^9 per mL, Platelets < 30 x 10^9 per mL
- History of cancer other than MM in the last 3 years requiring active chemotherapy or radiation
- Known reaction/allergy to IgG products
- Intracranial hemorrhage or embolic CVA in the last 6 months
- Hyperproteinemia
- Protein-losing enteropathy
- Creatinine Cl <30 ml/min
- Documented progression on BsAb
- Known history of Hyperprolinemia
- On current or previous IVIG (in the last 3 months)