Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia

Last updated: May 8, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Multiple Myeloma

Cancer

Lymphoproliferative Disorders

Treatment

IgPro20

Clinical Study ID

NCT06976476
24-137
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Diagnosis of RRMM receiving a commercially available bispecific antibody

  • Received at least 1 but no more than 4 cycles of BsAb

  • Received 2 or more lines of therapy for MM IgG ≤ 4 g/L excluding paraprotein. ForIgG Kappa MM, hypogammaglobulinemia will be determined by subtracting the M spikefrom IgG

  • Males or females greater than or equal to 18 years old at the time of consent

  • ECOG ≤ 3

  • Life expectancy > 12 months

Exclusion

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 orradiation

  • 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)

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: IgPro20
Phase: 2
Study Start date:
May 08, 2025
Estimated Completion Date:
May 08, 2029

Connect with a study center

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jersey 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Suffolk-Commack (All Protocol Activity)

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York 10065
    United States

    Active - Recruiting

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    Uniondale, New York 11553
    United States

    Active - Recruiting

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