Recruiting
Phase 2

IgPro20

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06976476

Conditions

Multiple Myeloma

Hypogammaglobulinemia

Hypogammaglobulinemia, Acquired

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IgPro20

Study Details

Brief 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).

Conditions

Multiple Myeloma

Hypogammaglobulinemia

Hypogammaglobulinemia, Acquired

Study ID

NCT06976476

Start date

May 8, 2025

Status verified date

Aug, 2026

Completion date

May 8, 2029

Anticipated

Primary completion date

May 8, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard of Care

Participants will only be observed

experimental: Standard of Care + IGRT prophylaxis with IgPro20

Participants will receive IGRT prophylaxis with IgPro20 in addition to standard of care

Interventions

IgPro20

Will be administered in addition to Standard of Care treatment. IgPro20 is intended for subcutaneous administration using an infusion pump

Primary outcome measure

  • Difference in overall infection rates between Standard of Care participants and participants receiving IgPro20 [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Zainab Shahid, MBBS

212-639-6483shahidz@mskcc.org

Sergio Giralt, MD

646-608-3731giralts@mskcc.org

Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 10065

Contacts

Zainab Shahid, MBBS

212-639-6483

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Zainab Shahnid, MBBS

212-639-6483

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Zainab Shahid, MBBS

212-639-6483

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activity)

Recruiting

Commack, New York, United States, 11725

Contacts

Zainab Shahid, MBBS

212-639-6483

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Zainab Shahid, MBBS

212-639-6483

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Zainab Shahid, MBBS

212-639-6483

Memorial Sloan Kettering Nassau (All Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Zainab Shahid, MBBS

212-639-6483

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Multiple Myeloma
  • Hypogammaglobulinemia
  • IgPro20
  • Memorial Sloan Kettering Cancer Center
  • 24-137

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-09-01.