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Phase IIInterventional
Prospective Randomized Phase II Study Evaluating Efficacy and Safety of IgPro20 as Infection Prophylaxis in Patients With Multiple Myeloma and Hypogammaglobulinemia Receiving Therapy With a Bispecific Monoclonal Antibody (BsAbs)
Protocol: 2026P000628NCT: NCT06976476
Overview
The main purpose of this study is to see if IgPro20 can prevent infection in people with multiple myeloma (MM) who have hypogammaglobulinemia from receiving bispecific monoclonal antibodies (BsAbs).
Eligibility
| Ages | 18 Years and older |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Adult, Older Adult |
Inclusion Criteria:
- Diagnosis of RRMM receiving a commercially available bispecific antibody
- Received at least 1 but no more than 4 cycles of BsAb
- 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 10^3 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)
