NCT06976476PHASE2Recruiting
Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia
Memorial Sloan Kettering Cancer Center
Start Date
5/8/2025
Completion Date
5/8/2029
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 Criteria
Age Range: 18 years to No maximum
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 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)
Interventions
DRUG
IgPro20
Conditions
Multiple MyelomaHypogammaglobulinemiaHypogammaglobulinemia, Acquired
Locations
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey 10065
United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey 07645
United States
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activity)
Commack, New York 11725
United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York 10604
United States
Mount Sinai Hospital
New York, New York 10029
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065
United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York 11553
United States