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New treatment option for Multiple Myeloma, Newly Diagnosed
Official title MRD-Adaptive Guided Immunotherapy With CAR-T for Transplant-Ineligible Patients With Multiple Myeloma
ClinicalTrials.gov ID: NCT07106736
What this study is testing
What is BCMA CAR-T?
BCMA CAR-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma, newly diagnosed.
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-center, clinical study to evaluate the efficacy and safety of a fully immunotherapy-based strategy guided by MRD-driven dynamic risk stratification in transplant-ineligible patients with newly diagnosed multiple myeloma.
- 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 to 75
You may be able to join if
- Age ≥ 18 years and ≤ 75 years.
- Participants with documented newly-diagnosed multiple myeloma according to IMWG diagnostic criteria.
- Measurable disease at screening, defined as: Serum M-protein level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or Light chain MM without...
- Patients deemed ineligible for high-dose chemotherapy with ASCT due to any of the following: Age ≥65 years; Investigator assessment of ineligibility...
- Tumor cells were BCMA and GPRC5D positive.
You likely can't join if
- Active amyloidosis.
- Central nervous system involvement.
- Prior BCMA-targeted therapy or CAR-T therapy.
- Active hepatitis B or hepatitis C virus infection.
- Known HIV infection.
- Life expectancy \<6 months.
See the full eligibility criteria
- Age ≥ 18 years and ≤ 75 years.
- Participants with documented newly-diagnosed multiple myeloma according to IMWG diagnostic criteria.
- Measurable disease at screening, defined as: Serum M-protein level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10...
- Patients deemed ineligible for high-dose chemotherapy with ASCT due to any of the following: Age ≥65 years; Investigator assessment of ineligibility; ECOG performance status 3-4; Repeated failure of hematopoietic stem...
- Tumor cells were BCMA and GPRC5D positive.
- Serum total bilirubin \<2 x upper limit of normal (ULN), serum AST and ALT \<3 x ULN, creatinine clearance ≥ 30mL/min (Cockroft-Gault formula).
- Informed Consent/Assent: All people have the ability to understand and the willingness to sign a written informed consent.
- Active amyloidosis.
- Central nervous system involvement.
- Prior BCMA-targeted therapy or CAR-T therapy.
- Active hepatitis B or hepatitis C virus infection.
- Known HIV infection.
- Life expectancy \<6 months.
- Woman who are pregnant or breastfeeding.
- Evidence of uncontrolled dysfunction of heart, lung, brain, and other important organs.
- Any other conditions that are not eligible for the trial in the judgement of the principal investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, 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.