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Study of IgPro20 to Prevent Infection in Patients with Multiple Myeloma and Hypogammaglobulinemia
Trial Status: active
This phase II trial tests how well adding IgPro20 to standard patient observation works in preventing infection in patients who are receiving treatment with bispecific antibodies for multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and who also have low levels of antibodies in their blood (hypogammaglobulinemia). Patients with multiple myeloma are at increased risk of both bacterial and viral infections because of the ways their disease and cancer treatments affect their immune system. When patients also have hypogammaglobulinemia, the level of immunoglobulins in their blood is low and the risk of infection is high. Immunoglobulins are antibodies, which are proteins made by the immune system to prevent infections and decrease the frequency and severity of infections. IgPro20 is a type of immunoglobulin replacement therapy. The active substance in IgPro20 is normal human immunoglobulin, a highly purified protein removed (extracted) from donated human blood. IgPro20 has been shown to help control the immune system when it is working abnormally. IgPro20 may be able to prevent infection in multiple myeloma patients with hypogammaglobulinemia by restoring abnormally low immunoglobulin levels to their normal range.
Inclusion Criteria
Diagnosis of relapsed refractory multiple myeloma (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
Eastern Cooperative Oncology Group (ECOG) ≤ 3
Life expectancy > 12 months
Exclusion Criteria
Hematopoietic stem cell transplant (HSCT) within 3 months before enrollment
Planned chimeric antigen receptor (CAR)-T therapy in the next 6 months
> 1 major (deep-seated) infection within the preceding 3 months
HIV infection, active hepatitis C virus (HCV), or active hepatitis B virus (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 cerebrovascular accident (CVA) in the last 6 months
Hyperproteinemia
Protein-losing enteropathy
Creatinine clearance (Cl) < 30 ml/min
Documented progression on BsAb
Known history of hyperprolinemia
On current or previous intravenous immunoglobulin (IVIG) (in the last 3 months)
Additional locations may be listed on ClinicalTrials.gov for NCT06976476.
I. To compare overall infection rates amongst (relapsed refractory [RR]) multiple myeloma patients with hypogammaglobulinemia receiving subcutaneous immunoglobulin (human immunoglobulin G [IgPro20]) to those in observational arm over a 6-month period.
SECONDARY OBJECTIVES:
I. To estimate the difference in the days of antibiotics (oral and intravenous) between the control (observation) and intervention group.
II. To estimate the difference in time to occurrence of a grade ≥ 3 infection between the 2 study arms.
III. To study the time to occurrence to the first infection among control and intervention group.
IV. To estimate the difference of the incidence of different types of infection, including bacterial and viral, between the 2 study arms.
V. To estimate the difference of the days of hospitalization between the control and intervention group.
VI. To estimate the difference in the intensive care unit (ICU) days in the control and intervention group.
VII. To estimate the difference differences in immunoglobulin A (IgA) and immunoglobulin M (IgM) between the 2 arms at the end of the study.
VIII. To estimate the differences in serum polyclonal immunoglobulin G (IgG) levels between the two study arms.
IX. To study the safety of IgPro20 in multiple myeloma (MM) patients receiving bispecific monoclonal antibodies (BsAbs).
X. To estimate the difference in infection-related MM treatment interruption between the study arms.
XI. To estimate the difference in health-related quality of life (HRQOL) between the study arm.
XII. To estimate the difference in the rates of serious bacterial infection between the control and intervention group.
XIII. To estimate the difference in the rates of grade ≥ 3 infection between the control and intervention group.
XIV. To estimate the difference in the rate of hospitalization or prolongation of hospitalization due to infection between the control and intervention group.
XV. To estimate the difference in the rate of MM treatment discontinuation or adjustment due to infection.
EXPLORATORY OBJECTIVE:
I. To assess the differences among clinical outcomes in patients with baseline hypogammaglobulinemia and those with treatment-induced hypogammaglobulinemia.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care observation and receive IgPro20 subcutaneously (SC) on days 1, 4, 8, 11, 15, and 22 of cycle 1 and days 1, 8, 15, and 22 of subsequent cycles. Cycles repeat every 28 days for up to 6 cycles in the absence of unacceptable toxicity. Patients also undergo collection of blood samples throughout the study.
ARM II: Patients undergo standard of care observation for 6 months. Patients also undergo collection of blood samples throughout the study.
Trial PhasePhase II
Trial Typeprevention
Lead OrganizationMemorial Sloan Kettering Cancer Center
