A Phase 2 Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia

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Full 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)

Purpose

People with multiple myeloma have a higher chance of getting infections because of the disease and its treatment. Some people who get a multiple myeloma drug called a bispecific monoclonal antibody (BsAb) develop hypogammaglobulinemia. The level of immunoglobulins in their blood is low and the risk of infection is high. Immunoglobulins are proteins made by the immune system to prevent infections.

Researchers are doing this study to see if IgPro20 can prevent infection in people with multiple myeloma who have hypogammaglobulinemia. IgPro20 works to restore low immunoglobulin levels to their normal range.

If you join this study, you will be randomly assigned to get one of these treatments:

  • IgPro20 plus standard treatment (such as antibiotics).
  • Standard treatment alone.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have multiple myeloma and hypogammaglobulinemia.
  • Have received at least 1 but no more than 4 cycles of BsAb treatment.
  • Be age 18 or older.
  • You may join this study even if you need help taking care of yourself. You may also join even if you are in a bed or chair for more than half the time you’re awake.

Contact

For more information or to see if you can join this study, please call Dr. Zainab Shahid’s office at 212-639-7810.

Protocol

24-137

Phase

Phase II (phase 2)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06976476