Immunoglobulins for Multiple Myeloma

(CHUQUL_HO001 Trial)

Overseen By Philippe Nadeau, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: CHU de Quebec-Universite Laval

Must be taking: BCMA-directed therapy

Disqualifiers: Pregnancy, Breastfeeding, 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: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to prevent infections in people with multiple myeloma receiving new antibody treatments. Although effective, these treatments can weaken the immune system, increasing infection risk. Participants will receive varying levels of immunoglobulin support (proteins that help fight infections) or none to determine the most effective approach. Individuals with multiple myeloma who have received these specific antibody therapies and at least one prior treatment might be suitable for this study. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for immunoglobulins?

Research has shown that immunoglobulin, a protein in the blood that helps fight infections, is generally safe for people with multiple myeloma. In studies, patients who received immunoglobulin treatments experienced 67% fewer infections, indicating they got sick less often. Most participants tolerated the treatment well, without serious side effects.

However, these treatments don't always improve other health issues related to multiple myeloma. While they help prevent infections, they might not enhance other aspects of the condition. Preventing infections remains crucial, as they can pose significant problems for people with multiple myeloma. Thus, while immunoglobulin support appears safe, its primary benefit is reducing infections. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using immunoglobulins for multiple myeloma because they offer a unique way to support the immune system in a condition where it's often compromised. Unlike standard treatments that primarily focus on directly targeting cancer cells, such as chemotherapy or proteasome inhibitors, immunoglobulins provide a boost to the patient's immune response. This can be particularly beneficial for patients with low levels of IgG, as seen in the trial's Group A and B, potentially improving their ability to fight infections. The flexibility in administration, either subcutaneously or intravenously, also adds convenience and adaptability, making it a promising supportive therapy alongside existing cancer treatments.

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

Research shows that immunoglobulin support can help reduce infections in patients with multiple myeloma. In this trial, participants will be divided into groups to receive varying levels of immunoglobulin support. Group A will maintain IgG levels of 8-10 g/L, while Group B will maintain levels of 4-6 g/L. Group C will not receive immunoglobulin support unless specific conditions are met, allowing crossover to Group A or B. Previous studies have shown that starting immunoglobulin replacement therapy significantly lowers the chance of infections and reduces the need for antibiotics. This therapy has been proven to lower the risk of serious infections in patients undergoing certain cancer treatments. Overall, evidence supports that immunoglobulin support can effectively prevent infections in multiple myeloma patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Dr Vincent Laroche, MD,FRCPC

Principal Investigator

CHU de Québec-Université Laval

Dr Julie Côté, MD,FRCPC

Principal Investigator

CHU de Québec-Université Laval

Dr Julie Côté, MD,FRCPC

Principal Investigator

CHU de Québec-Université Laval

Are You a Good Fit for This Trial?

This trial is for multiple myeloma patients who are receiving a new BCMA-targeted therapy and have not had severe or frequent infections. Participants must have an IgG level of at least 4 g/L to join.

Inclusion Criteria

I have (or have not) been on immunoglobulin support before.

I am starting treatment with a BCMA-targeted therapy.

I am 18 years old or older.

Exclusion Criteria

Pregnancy or breastfeeding

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive immunoglobulin support (subcutaneous or intravenous) based on their IgG levels

3 months

Regular visits for Ig administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Periodic visits for infection rate monitoring and quality of life assessment

Vaccinal response assessment (optional)

Examine vaccinal response with specific antibody titers to tetanus for patients with no previous Ig support

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Immunoglobulins

Trial Overview The study tests different target levels of immunoglobulin G (IgG) in the blood, aiming for either 8-10 g/L or 4-6 g/L, to see if these can prevent infections while undergoing novel BCMA-directed bispecific antibody therapies.

How Is the Trial Designed?

Group I: Group C Experimental Treatment 1 Intervention

No immunoglobulin support. If pre specified conditions are met, crossover to Group A or B.

Group II: Group B IgG level 4-6 g/L Experimental Treatment 1 Intervention

Immunglobulin support (subcutaneous or intravenous)

Group III: Group A IgG level 8-10 g/L Active Control 1 Intervention

Immunoglobulin support (subcutaneous or intravenous)

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40305667/

Real-world effectiveness of immunoglobulin replacement ... 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 ...

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

Real-world effectiveness of immunoglobulin replacement for ... The likelihood of infections/severe infections and associated antimicrobial use decreased after IgRT initiation.

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

IgG replacement in multiple myeloma | Blood Cancer Journal HG (IgG <500 mg/dL) occurred in 87% of patients who received the 405 μg dose and in 71% of those who received the 800 μg dose. Results from the ...

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

Real-world effectiveness of immunoglobulin replacement ... In this study, we found that the IgG levels in patients diagnosed with MM were routinely monitored with more than 95% of patients undergoing IgG ...

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/PMC11272770/

IgG replacement in multiple myeloma - PMC - PubMed Central A 2022 systematic review and meta-analysis of randomized controlled trials did not show improved clinical outcomes when IVIG was used to treat ...

7. ashpublications.org ashpublications.org/bloodadvances/article/9/18/4720/546292/Immunoglobulin-prophylaxis-should-be-initiated

Immunoglobulin prophylaxis should be initiated after bispecific ... Immunoglobulin prophylaxis should be initiated after bispecific antibody therapy in multiple myeloma, regardless of IgG levels Open Access.

8. 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.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2473952925004306

Immunoglobulin prophylaxis should be initiated after ... The risk of infections with bsAb therapy is concerningly high. With every continued month on BCMA bsAb therapy, 3% of patients develop de novo ...

10. 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 ... IVIG treatment led to a 67% reduction in infection rates among MM patients on BCMA BsAb therapies. BsAb therapies, especially teclistamab, are ...