BridgeMD
New treatment option for Extramedullary Multiple Myeloma
Official title Aponermin-Based Bridging Therapy Prior to CAR-T Infusion in Relapsed/Refractory Multiple Myeloma Patients With Extramedullary Disease
ClinicalTrials.gov ID: NCT06793475
What this study is testing
What is anti-BCMA/GPRC5D bispecific CAR-T?
anti-BCMA/GPRC5D bispecific CAR-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for extramedullary multiple myeloma.
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
- This is a prospective, single-arm, multicenter, open-label study to evaluate the efficacy and safety of aponermin-based bridging therapy prior to CAR-T infusion in relapsed/refractory multiple myeloma patients with extramedullary disease.
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
- Be informed and voluntarily sign the Informed Consent Form (ICF).
- Age ≥18 years.
- Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines)
- people with diagnosed relapsed or refractory extramedullary multiple myeloma according to IMWG criteria and have had at least 1 prior lines of...
- ECOG score is ≤ 2
You likely can't join if
- Plasma cell leukemia or solitary plasmacytoma.
- Prior exposure to both BCMA- and GPRC5D-targeted therapies (patients who have received only one of these targeted therapies are eligible for...
- Evidence of primary or secondary resistance to elotuzumab, carfilzomib, or thalidomide.
- Pregnant or breastfeeding women, or women with pregnancy plans within the next six months.
- Infectious diseases (e.g., HIV, active tuberculosis, etc.).
- Active hepatitis B or hepatitis C infection.
See the full eligibility criteria
- Be informed and voluntarily sign the Informed Consent Form (ICF).
- Age ≥18 years.
- Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines)
- people with diagnosed relapsed or refractory extramedullary multiple myeloma according to IMWG criteria and have had at least 1 prior lines of therapy. Extramedullary disease (EMD) is defined as soft-tissue...
- ECOG score is ≤ 2
- No active infections.
- Negative for HBV-DNA, HCV-RNA, and HIV.
- Liver function meeting the following criteria: Total bilirubin \<1.5 × ULN (patients with Gilbert's syndrome must have total bilirubin \<3 × ULN), ALT and AST \<3 × ULN.
- Renal function meeting the following criteria: Creatinine clearance ≥30mL/min (calculated using the Cockcroft-Gault formula).
- Blood tests conducted within 7 days before screening must meet the following standards: WBC count ≥1.0×10⁹/L, Hemoglobin ≥70g/L, Platelet count ≥75×10⁹/L or ≥50×10⁹/L (if ≥50% plasma cells are present in bone marrow)...
- Patients receiving hematopoietic growth factors (e.g., erythropoietin, granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF], and platelet-stimulating factors such as...
- Non-pregnant female patients must confirm pregnancy negativity at screening (via β-hCG serum test or urine pregnancy test).
- Male patients, female patients of childbearing potential, and their partners must agree to use effective contraception during the treatment period and for at least 3 months after CAR-T cell infusion.
- Male patients must agree not to donate sperm, starting from the initial screening period until 90 days after the last dose.
- Patients must agree to comply with study procedures and follow-up visits.
- Plasma cell leukemia or solitary plasmacytoma.
- Prior exposure to both BCMA- and GPRC5D-targeted therapies (patients who have received only one of these targeted therapies are eligible for enrollment).
- Evidence of primary or secondary resistance to elotuzumab, carfilzomib, or thalidomide.
- Pregnant or breastfeeding women, or women with pregnancy plans within the next six months.
- Infectious diseases (e.g., HIV, active tuberculosis, etc.).
- Active hepatitis B or hepatitis C infection.
- Abnormal vital signs or inability to cooperate with examinations.
- Mental or psychological disorders preventing compliance with treatment or treatment evaluation.
- Severe allergic constitution or severe allergic history, particularly to aponermin, carfilzomib, thalidomide, dexamethasone or other effective components or excipients of related drugs.
- Significant dysfunction of major organs, such as the heart, lungs, or brain. 9) Patients with severe autoimmune diseases. 11) Any other reasons deemed unsuitable for participation in this study as determined by the...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Tianjin, China
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 Beijing, China; Tianjin, China. 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.