Multiple Myeloma study: IGI
Official title A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma
ClinicalTrials.gov ID: NCT06980480
What this study is testing
What is IGI, 10%?
An investigational IV infusion of immune globulin being studied to help prevent infections in multiple myeloma patients receiving BCMA×CD3 bispecific antibody therapy. It is designed to supply antibodies that support the immune system in fighting infections.
Also referred to as TAK-339, Gammagard Liquid, KIOVIG.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether giving immune globulin regularly can prevent infections in people with multiple myeloma who are also receiving a specific antibody therapy.
- Who it's for
- Adults who have multiple myeloma and are being treated with a BCMA‑CD3 bispecific antibody.
- What's involved
- Participants are randomly placed in one of two groups: one gets the immune‑globulin infusion every 3 or 4 weeks for a year, the other gets the infusion only if they develop a serious infection. They will have regular clinic visits for the infusions and check‑ups.
- Time commitment
- The trial lasts up to about 14 months, including an 8‑week screening, with 15 to 19 clinic visits depending on the dosing schedule.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The participants must have a documented diagnosis of Multiple Myeloma (MM) according to the guidelines by the International Myeloma Working Group...
- Participant who recently started teclistamab monotherapy within the first 8 weeks of their planned treatment schedule and are planned to receive...
- The participant has provided informed consent (that is, in writing, documented via a signed and dated Informed Consent Form [ICF]) and any required...
- The participant is at least 18 years of age at the time of signing the ICF.
- To use a highly effective contraceptive method.
You likely can't join if
- The participant has not achieved at least a minimal response to teclistamab during the screening period after signing the ICF and within 8 weeks of...
- The participant has a current serious infection or greater than (\>) 1 serious infection in the past 3 months before screening.
- The participant has a documented polyclonal IgG level less than (\<) 150 milligrams per deciliter (mg/dL) at the most recent assessment before...
- The participant is currently receiving immunoglobulin products or has received immunoglobulin products within 16 weeks before screening.
- The participant has received a hyperimmune or specialty high-titer immunoglobulin product (example, cytomegalovirus immune globulin, varicella-zoster...
- The participant has received live viral vaccines within 30 days before screening.
See the full eligibility criteria
Who can join
- The participants must have a documented diagnosis of Multiple Myeloma (MM) according to the guidelines by the International Myeloma Working Group (IMWG) before enrollment.
- Participant who recently started teclistamab monotherapy within the first 8 weeks of their planned treatment schedule and are planned to receive teclistamab for the next 12 months.
- The participant has provided informed consent (that is, in writing, documented via a signed and dated Informed Consent Form [ICF]) and any required privacy authorization before the initiation of any study procedures.
- The participant is at least 18 years of age at the time of signing the ICF.
- To use a highly effective contraceptive method.
- To avoid donating ova.
What rules you out
- The participant has not achieved at least a minimal response to teclistamab during the screening period after signing the ICF and within 8 weeks of the first step-up dose of teclistamab.
- The participant has a current serious infection or greater than (\>) 1 serious infection in the past 3 months before screening.
- The participant has a documented polyclonal IgG level less than (\<) 150 milligrams per deciliter (mg/dL) at the most recent assessment before teclistamab initiation (within 4 weeks) as assessed by the investigator...
- The participant is currently receiving immunoglobulin products or has received immunoglobulin products within 16 weeks before screening.
- The participant has received a hyperimmune or specialty high-titer immunoglobulin product (example, cytomegalovirus immune globulin, varicella-zoster immune globulin, hepatitis B immune globulin) within 30 days before...
- The participant has received live viral vaccines within 30 days before screening.
- The participant has an Eastern Cooperative Oncology Group performance status score of \>2.
- The participant has an active viral or bacterial infection or symptoms/signs of such an infection requiring treatment with anti-infectives within 1 week before enrollment.
- The participant has received other B Cell Maturation Antigen (BCMA)\ Cluster of Differentiation (CD3)-directed Bispecific Antibody therapy (BsAb), BCMA-targeted chimeric antigen receptor T-cell (CAR T-cell), or...
- The participant is scheduled to undergo plasmapheresis during the course of study or has undergone plasmapheresis in the last 16 weeks before screening.
- The participant may be excluded from the study if, in the opinion of the investigator, the participant is at high risk for symptomatic hyperviscosity syndrome.
- The participant has major surgery scheduled during the study, or the participant has not fully recovered from a recent major surgery (as judged by the investigator) during screening (participants with planned surgical...
- The participant has an active secondary (non-MM) malignancy or other medical condition with life-expectancy of less than (\<) 2 years.
- The participant has a known history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) after Intravenous Immunoglobulin (IVIG) and/or immune serum globulin...
- The participant has a known history or current diagnosis of thromboembolic episodes such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, peripheral artery...
- The participant has moderate to severe renal dysfunction based on an estimated glomerular filtration rate less than (\<) 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2), as defined by kidney disease...
- The participant has a known history of or is positive at screening for one or more of the following: hepatitis B surface antigen, Polymerase Chain Reaction (PCR) for hepatitis C virus, PCR for Human Immunodeficiency...
- The participant has a documented diagnosis of a form of primary immunodeficiency (PID) involving a defect in antibody formation and requiring IgG replacement, as defined according to the International Union of...
- The participant has a persistent serum aspartate aminotransferase and alanine aminotransferase \>3.0 times the upper limit of normal (ULN) at screening (may be repeated once to determine if it is persistent).
- The participant has an immunoglobulin A (IgA) deficiency (\<0.07 grams per liter [g/L]) with antibodies to IgA and a history of hypersensitivity reaction to IVIG.
- Participant with a known systemic hypersensitivity to any of the excipients of IGI, 10% in accordance with the investigator's brochure/package insert/Summary of Product Characteristics.
- Known substance abuse including opiates, psychostimulant agents, or other illicit drugs with the exception of cannabinoids within 12 months of screening.
- The participant has anemia that would preclude phlebotomy for laboratory studies, according to standard practice at the site, at the discretion of the investigator (may be repeated once to determine if it has resolved).
- The participant has a medical condition, laboratory finding, or physical examination finding that precludes participation or with clinical evidence of any significant acute or chronic disease that, in the opinion of the...
- The participant is receiving immunosuppressive treatment (other than for MM or corticosteroids) at screening or plans to receive immunosuppressive treatment after study enrollment.
- The participant is not willing and able to comply with the protocol requirements.
- The participant has participated or is scheduled to participate in another clinical study involving an investigational product (IP) or investigational device within 30 days before screening and during the course of the...
- The participant is a family member or employee of the investigator or the investigator's site staff.
- The participant is pregnant or has a positive pregnancy test or is lactating at the time of screening or enrollment.
The study team makes the final eligibility decision.
Where it is enrolling
- Mobile, Alabama, United States
- Orange, California, United States
- Westwood, Kansas, United States
- Baltimore, Maryland, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Albany, New York, United States
- Kogarah, New South Wales, Australia
- Douglas, Queensland, Australia
- Greenslopes, Queensland, Australia
- Adelaide, South Australia, Australia
- St Albans, Victoria, Australia
- Murdoch, Western Australia, Australia
- Melbourne, Australia
- Linz, Austria
- Sankt Pölten, Austria
- Vienna, Austria
- Joinville, Santa Catarina, Brazil
- Porto Alegre, Brazil
- Rio de Janeiro, Brazil
+ 41 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Mobile, Alabama, United States; Orange, California, United States; Westwood, Kansas, United States; Baltimore, Maryland, United States; Detroit, Michigan, United States; St Louis, Missouri, United States and 55 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.