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New treatment option for Multiple Myeloma
Official title Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia
ClinicalTrials.gov ID: NCT06976476
What this study is testing
What is IgPro20?
IgPro20 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple myeloma.
Also referred to as HIZENTRA.
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 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).
- Phase 2: a mid-size study of how well it works
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
- Diagnosis of RRMM receiving a commercially available bispecific antibody
- Received at least 1 but no more than 4 cycles of BsAb
- Males or females greater than or equal to 18 years old at the time of consent
- ECOG ≤ 3
- Life expectancy \> 12 months
You likely can't join if
- HSCT within 3 months before enrollment
- Planned CAR-T therapy in the next 6 months
- \>1 major (deep-seated) infection within the preceding 3 months
- HIV infection, Active HCV, or Active HBV infection
- Pregnancy
- Neutrophils \< 500 x 10\^9 per mL, Platelets \< 30 x 10\^9 per mL
See the full eligibility criteria
- Diagnosis of RRMM receiving a commercially available bispecific antibody
- Received at least 1 but no more than 4 cycles of BsAb
- Males or females greater than or equal to 18 years old at the time of consent
- ECOG ≤ 3
- Life expectancy \> 12 months
- HSCT within 3 months before enrollment
- Planned CAR-T therapy in the next 6 months
- \>1 major (deep-seated) infection within the preceding 3 months
- HIV infection, Active HCV, or Active HBV infection
- Pregnancy
- Neutrophils \< 500 x 10\^9 per mL, Platelets \< 30 x 10\^9 per mL
- History of cancer other than MM in the last 3 years requiring active chemotherapy or radiation
- Known reaction/allergy to IgG products
- Intracranial hemorrhage or embolic CVA in the last 6 months
- Hyperproteinemia
- Protein-losing enteropathy
- Creatinine Cl \<30 ml/min
- Documented progression on BsAb
- Known history of Hyperprolinemia
- On current or previous IVIG (in the last 3 months)
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
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 - 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?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.