IgPro20 for Multiple Myeloma

Recruiting at 7 trial locations

Overseen By Sergio Giralt, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Bispecific antibodies

Must not be taking: IVIG

Disqualifiers: HIV, Active HCV, Active HBV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Zainab Shahid, MBBS

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for individuals with multiple myeloma, a type of blood cancer, who also have low levels of immunoglobulins (antibodies) due to treatment with bispecific monoclonal antibodies. The study aims to include those needing prevention against infections.

Inclusion Criteria

Life expectancy > 12 months

I have had at least 2 treatments for my MM and my IgG levels are low.

I have relapsed or refractory multiple myeloma and am receiving a bispecific antibody treatment.

Exclusion Criteria

Pregnancy

I have been on IVIG therapy within the last 3 months.

I had a stem cell transplant less than 3 months ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• IgPro20

Trial Overview The intervention being tested is IgPro20, which is an immunoglobulin product given subcutaneously. The goal is to determine if it can prevent infections in patients with multiple myeloma and hypogammaglobulinemia.

Participant Groups

Group I: Standard of Care + IGRT prophylaxis with IgPro20 Experimental Treatment 1 Intervention

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

Group II: Standard of Care Active Control 1 Intervention

Participants will only be observed

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+