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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether IgPro20, an immunotherapy, can prevent infections in people with multiple myeloma who have low antibody levels after certain cancer treatments. Participants will receive either the usual care or the usual care plus IgPro20. Suitable candidates have multiple myeloma, are receiving bispecific antibody treatments, and have undergone two or more previous treatments for their condition. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently or have recently been on IVIG (intravenous immunoglobulin) in the last 3 months, you may not be eligible to participate.

Is there any evidence suggesting that IgPro20 is likely to be safe for humans?

Research has shown that IgPro20 is generally well-tolerated. In one study with 85 patients, about 46% experienced some side effects, though most were mild. Another report indicated that IgPro20 is safe when administered subcutaneously, with few serious side effects. While research continues, these findings suggest IgPro20 is safe for human use, particularly since it is already used for other conditions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple myeloma?

Researchers are excited about IgPro20 for multiple myeloma because it offers a novel approach to treatment. Unlike standard therapies, which typically rely on chemotherapy and immunomodulatory drugs, IgPro20 is used as an immune globulin replacement therapy (IGRT) prophylaxis. This means it works by boosting the immune system's ability to fight cancer cells more effectively. By combining IgPro20 with the standard of care, there is potential for enhanced protection against infections, a common complication in multiple myeloma patients. This unique mechanism of action is what sets IgPro20 apart and fuels optimism for improved patient outcomes.

What evidence suggests that IgPro20 might be an effective treatment for multiple myeloma?

Research has shown that IgPro20 might help prevent infections in people with multiple myeloma who have low antibody levels. In this trial, one group of participants will receive standard care plus IGRT prophylaxis with IgPro20. Studies have found that starting IgPro20 significantly reduces the risk of infections. Specifically, research has demonstrated a clear reduction in infections after beginning IgPro20 treatment compared to before. This suggests that IgPro20 may enhance the immune system's ability to fight infections in these patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Zainab Shahid, MBBS

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10099597/

Real‐world results with IgPro20 for hypo The effectiveness analysis included 81 patients because four patients did not have effectiveness data available for analysis (Figure 1).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06976476

NCT06976476 | Study of IgPro20 to Prevent Infection in ... 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 ...

3. ashpublications.org ashpublications.org/bloodadvances/article/9/15/3780/537056/Real-world-effectiveness-of-immunoglobulin

Real-world effectiveness of immunoglobulin replacement for ... At 3 months, significantly lower odds of infections (OR, 0.71; 95% CI, 0.56-0.89; P = .0004) were observed after IgRT initiation than before ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2473952925002551

Real-world effectiveness of immunoglobulin replacement ... The results were reported using descriptive statistics. A total of 6062 patients with MM were identified (56.2% male; median age, 65.0 years).

5. mskcc.org mskcc.org/cancer-care/clinical-trials/24-137

A Phase 2 Study of IgPro20 to Prevent Infection in People ... Researchers are doing this study to see if IgPro20 can prevent infection in people with multiple myeloma who have hypogammaglobulinemia.

6. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1528414/full

Patient-reported outcomes with subcutaneous ... The safety data reported were consistent with the existing evidence in PID that SCIG is generally well tolerated with a favorable safety profile ...

7. withpower.com withpower.com/trial/igpro20-for-multiple-myeloma-a4dd3

IgPro20 for Multiple Myeloma 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 ...