Using IgPro20 to prevent infections in patients with multiple myeloma and low immunoglobulin levels

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of IgPro20 in preventing infections in individuals diagnosed with multiple myeloma who also have hypogammaglobulinemia. Participants will be those receiving bispecific monoclonal antibodies and will have undergone a specific number of treatment cycles. The study aims to determine if IgPro20 can enhance the immune response and reduce infection rates in this vulnerable population.

Why it matters

Who can join: the full rules

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)

Where it's running

• Emory University (Data Collection Only)
  Atlanta, Georgia, United States Recruiting
• Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (All Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (All Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk-Commack (All Protocol Activity)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (All Protocol Activities)
  Harrison, New York, United States Recruiting

Study contacts

• Principal investigator: Zainab Shahid, MBBS — Memorial Sloan Kettering Cancer Center
• Study coordinator: Zainab Shahid, MBBS
• Email: shahidz@mskcc.org
• Phone: 212-639-6483

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.