Immune Globulin Infusion for Multiple Myeloma

Not yet recruiting at 19 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Takeda

Must be taking: Teclistamab

Must not be taking: Immunoglobulin products, Live vaccines

Disqualifiers: Serious infection, Renal dysfunction, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 15

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Immune Globulin Infusion (IGI, 10%) can prevent infections in people with multiple myeloma, a type of bone marrow cancer, who are receiving a specific antibody treatment. Participants will be divided into two groups: one will receive IGI, 10% regularly for a year, while the other will receive it only if they develop a serious infection. This trial suits those with a confirmed diagnosis of multiple myeloma who have recently started a new antibody treatment and plan to continue it for the next year. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are receiving immunosuppressive treatment (other than for multiple myeloma or corticosteroids), you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatment is likely to be safe?

Research has shown that Immune Globulin Infusion (IGI, 10%) is usually well-tolerated by patients. Studies have demonstrated that it can significantly reduce the number of infections. For instance, one study found a 67% reduction in infections among patients with multiple myeloma treated with BCMA therapies who received IGI.

Most people do not experience major problems with IGI treatments. However, blood clots have been reported in 0.5% to 15% of patients, so discussing personal risk with a healthcare provider is important.

IGI is already used for other conditions, indicating a well-established safety record. Always consider consulting a doctor about health needs and potential side effects. ^{1 2 3 4 5}

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

Unlike the standard of care for multiple myeloma, which often involves chemotherapy, stem cell transplants, and targeted therapies, IGI, 10% offers a novel approach by using immune globulin infusions to prevent infections. Researchers are excited about IGI, 10% because it focuses on boosting the immune system in a more targeted manner, potentially reducing infection rates for patients with compromised immune systems. This treatment is administered intravenously and can be tailored to provide either primary infection prevention or secondary infection prophylaxis, depending on the patient's needs, offering a flexible and personalized treatment option.

What evidence suggests that IGI, 10% might be an effective treatment for preventing infections in multiple myeloma patients?

Research has shown that Immune Globulin Infusion (IGI, 10%) can help prevent infections in people with multiple myeloma. In this trial, participants will be randomized into different treatment arms to receive IGI, 10% for infection prophylaxis. Studies indicate that IGI, 10% can reduce serious infections by up to ten times in these patients. For those receiving certain antibody treatments, IGI, 10% is associated with better overall health outcomes. It has also lowered infection rates in patients with blood-related cancers. This treatment is recommended to reduce infection risks in these cases. ^{1 6 7 8 9}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

Adults with multiple myeloma who've recently started teclistamab treatment can join this study. They must follow strict birth control guidelines, not donate eggs, and have confirmed multiple myeloma diagnosis per IMWG standards. Informed consent is required.

Inclusion Criteria

I have signed the consent form for this study.

I am using a highly effective method of birth control.

I must not donate eggs during the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 8 weeks

Treatment

Participants receive IGI, 10% for primary or secondary infection prophylaxis

12 months

15 visits (4-week interval) or 19 visits (3-week interval)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IGI, 10%

Trial Overview The trial tests if Gammagard Liquid (IGI, 10%) prevents infections in those undergoing BCMA x CD3 bispecific antibody therapy for multiple myeloma. Participants are randomly placed into two groups: one receiving IGI regularly for a year, the other only after serious infection.

How Is the Trial Designed?

Group I: Primary Infection Prophylaxis: IGI, 10% Experimental Treatment 1 Intervention

Participants randomized to primary infection prophylaxis will receive a 400 milligrams per kilogram (mg/kg) dose of IGI, 10%, intravenously (IV) every 3 or 4 weeks within 3 days after randomization up to 12 months.

Group II: Secondary Infection Prophylaxis: IGI, 10% Active Control 1 Intervention

Participants randomized to secondary infection prophylaxis will receive a 400 mg/kg dose of IGI, 10%, IV every 3 or 4 weeks only after experiencing at least one serious infection, as determined by the investigator, for the remainder of the 12 months observational period.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Baxalta Innovations GmbH, now part of Takeda

Collaborator

Trials

1

Recruited

40+

Takeda Development Center Americas, Inc.

Industry Sponsor

Trials

58

Recruited

10,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06980480

NCT06980480 | A Study of Gammagard Liquid (Immune ... The main aim of this study is to learn how well the Immune Globulin Infusion (human), 10 percentage (%) (IGI, 10%) can help prevent infections in participants ...

2. nature.com nature.com/articles/s41408-025-01282-0

Effect of Intravenous Immunoglobulin (IVIG ... In recipients of BCMA-directed bsAb, IVIG supplementation was associated with an improved clinical outcome, including favorable IFS and OS.

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

Real-world effectiveness of immunoglobulin replacement for ... IgRT has been shown to be effective in reducing the infection rates in patients with hematologic malignancies10-13 and is recommended by ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10618720/

IVIg Use Associated with Ten-Fold Reduction of Serious ... Previously, we reported on the successful use of IVIg to reduce infection rates in multiple myeloma patients with HGG and nonprogressive disease (22), as well ...

5. ash.confex.com ash.confex.com/ash/2024/webprogram/Paper199374.html

256 Effects of Intravenous Immunoglobulin ... Conclusion: Primary IVIG supplementation reduces the risk of high-grade infections in patients receiving teclistamab therapy. IVIG ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12018942/

Effect of Intravenous Immunoglobulin (IVIG) ... Kaplan-Meier curve showing progression-free survival in patients with myeloma treated with BCMA-directed bispecific antibody therapy, stratified by IVIG status.

7. nature.com nature.com/articles/s41408-024-01107-6

IgG replacement in multiple myeloma | Blood Cancer Journal Infections occurred during or after ide-cel infusion in 82%, and the most common infections included upper respiratory tract infection (12%) and ...

8. pharmacytimes.com pharmacytimes.com/view/ivig-therapy-reduced-infections-by-67-in-patients-with-multiple-myeloma

IVIG Therapy Reduced Infections by 67% in Patients With ... Treatment with intravenous Immunoglobulin (IVIG) following infection from BCMA therapies yielded a 67% decrease in infections in patients ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0006497120305589

Intravenous immune globulin and thromboembolic adverse ... IVIg products have carried a boxed safety warning about the risk of thromboembolic events (TEEs), with TEEs reported in 0.5% to 15% of patients treated with ...