BridgeMD
A study investigating the safety and efficacy of academically-produced CAR T cells compared with standard treatment for patients with multiple myeloma whose disease has returned or not responded to previous treatments.
EU CTIS ID: 2025-524876-43-00
What this study is testing
To compare progression free survival (PFS) of patients randomized to PoC ARI0002h CAR T-cells versus current SoC in patients previously treated with 2-4 lines of therapy
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Documented historical diagnosis of Multiple Myeloma
- Received 2 to 4 prior lines of antimyeloma therapy, including an IMiD, a PI and an anti-CD38 mAb.
- Refractory to the last line of treatment by IMWG criteria
- Measurable disease at screening per IMWG criteria
- Candidates to receive at least 1 of the 5 SoC regimens (PVd, PCd, EPd, DKd or Kd)
- Aged 18 years or older
You likely can't join if
- Received one of the following prior therapies: BCMA-targeted therapy, T-cell engager therapy, CAR T-cell therapy, or other genetically modified T-cell therapy
- Active or prior history of central nervous system (CNS) or meningeal involvement of MM
- Cardiac atrial or cardiac ventricular MM involvement.
- History of or active plasma cell leukemia, Waldenstrom’s macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome, or amyloidosis.
- Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
- Females who are pregnant or breastfeeding
See the full eligibility criteria
- Documented historical diagnosis of Multiple Myeloma
- Received 2 to 4 prior lines of antimyeloma therapy, including an IMiD, a PI and an anti-CD38 mAb.
- Refractory to the last line of treatment by IMWG criteria
- Measurable disease at screening per IMWG criteria
- Candidates to receive at least 1 of the 5 SoC regimens (PVd, PCd, EPd, DKd or Kd)
- Aged 18 years or older
- Capable of giving informed consent
- ECOG/WHO performance status of 0-2
- Adequate hematological, renal, hepatic, pulmonary, and cardiac function
- Received one of the following prior therapies: BCMA-targeted therapy, T-cell engager therapy, CAR T-cell therapy, or other genetically modified T-cell therapy
- Active or prior history of central nervous system (CNS) or meningeal involvement of MM
- Cardiac atrial or cardiac ventricular MM involvement.
- History of or active plasma cell leukemia, Waldenstrom’s macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome, or amyloidosis.
- Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
- Females who are pregnant or breastfeeding
- Participants who are not willing to practice highly effective birth control
- Life expectancy < 12 weeks
- Current participation in another clinical trial
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.