Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IgPro20.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma, Hypogammaglobulinemia, Hypogammaglobulinemia, Acquired. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
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).
Interventions
- Drug IgPro20
Will be administered in addition to Standard of Care treatment. IgPro20 is intended for subcutaneous administration using an infusion pump
Primary outcome measures
- Difference in overall infection rates between Standard of Care participants and participants receiving IgPro20 [Time frame: 6 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 8 centers
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activity) — Commack
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
- Mount Sinai Hospital — New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale
Identifiers
NCT: NCT06976476 · 24-137