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Search / Trial NCT06976476

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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · May 8, 2025

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Multiple Myeloma Hypogammaglobulinemia Ig Pro20 Memorial Sloan Kettering Cancer Center 24 137

ClinConnect Summary

This clinical trial is studying a medication called IgPro20 to see if it can help prevent infections in people who have multiple myeloma (a type of blood cancer) and a condition called hypogammaglobulinemia, which means they have low levels of certain antibodies that help fight infections. The trial is specifically looking at patients who are receiving treatment with bispecific monoclonal antibodies (a type of targeted therapy). Researchers hope that by giving IgPro20, they can reduce the risk of infections that these patients may face during their treatment.

To participate in this study, individuals must be diagnosed with relapsed or refractory multiple myeloma and currently receiving a bispecific antibody treatment. They should be at least 18 years old and generally in good health, with a life expectancy of more than 12 months. However, certain health issues, such as recent major infections or specific blood conditions, may prevent someone from joining the trial. Participants will receive the study medication and will be monitored for its effects on their health and infection rates. This trial is currently recruiting, and all genders are welcome to apply.

Gender

ALL

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

About Memorial Sloan Kettering Cancer Center

Memorial Sloan Kettering Cancer Center (MSKCC) is a world-renowned institution dedicated to cancer treatment, research, and education. As a leading clinical trial sponsor, MSKCC focuses on advancing innovative cancer therapies through rigorous scientific investigation and collaboration. The center's multidisciplinary team of experts employs cutting-edge methodologies to design and conduct trials that aim to improve patient outcomes and enhance understanding of cancer biology. With a commitment to translating research findings into clinical practice, MSKCC plays a pivotal role in shaping the future of oncology care and ensuring that patients have access to the latest therapeutic advancements.

Locations

New York, New York, United States

New York, New York, United States

Harrison, New York, United States

Middletown, New Jersey, United States

Montvale, New Jersey, United States

Basking Ridge, New Jersey, United States

Uniondale, New York, United States

Commack, New York, United States

Patients applied

0 patients applied

Trial Officials

Zainab Shahid, MBBS

Principal Investigator

Memorial Sloan Kettering Cancer Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported