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)
Memorial Sloan Kettering Cancer Center
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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\^9 per mL, Platelets \< 30 x 10\^9 per mL * History of cancer…
Interventions
- DrugIgPro20
Will be administered in addition to Standard of Care treatment. IgPro20 is intended for subcutaneous administration using an infusion pump
Locations (8)
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (All Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (All Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activity)Commack, New York
- Memorial Sloan Kettering Westchester (All Protocol Activities)Harrison, New York
- Mount Sinai HospitalNew York, New York