BridgeMD
A Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel
EU CTIS ID: 2025-521975-30-00
What this study is testing
To characterize the efficacy of cilta-cel infusion following a fludarabine free LD regimen (Cohort A) or a low-dose cilta-cel infusion following a standard cyclophosphamide and fludarabine LD regimen (Cohort B)
- Therapeutic exploratory (Phase II)
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
- 1. At the time of informed consent, be ≥18 years of age (or at least the legal age of consent in the jurisdiction in which the study is taking place) but ≤80 years of age.
- 2. Documented diagnosis of NDMM according to the most recent IMWG diagnostic criteria and measurable disease at diagnosis (prior to start of any anti-myeloma therapy)
- 3. Not considered a candidate for high-dose chemotherapy with stem cell transplantation due to: -Advanced age; or -Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with stem cell transplantation; or -Participant refusal of high-dose chemotherapy with stem cell transplantation as initial treatment.
- 4. Participant must have received induction therapy. Initially, only participants receiving triplet induction therapy with DRd or VRd will be enrolled. Only after sponsor notification, participants receiving quadruplet DVRd induction therapy may be enrolled.Participants must have achieved ≥PR to be enrolled on the most recent disease assessment.
- 5. ECOG Performance Status score of 0 or 1
- 6. Clinical laboratory values as defined in the protocol
You likely can't join if
- 1. Prior systemic therapy for multiple myeloma or smoldering myeloma other than VRd, DRd or DVRd as per inclusion 4a and short course of corticosteroids . For participants who require emergency treatment, refer to protocol Section 4.4.
- 2. Radiation therapy for treatment of plasmacytoma within 14 days before enrollment. Palliative radiation for pain control secondary to lytic lesion is allowed within 14 days of enrollment, if the radiation portal covered ≤5% of the bone marrow reserve
- 3. Frailty index of ≥ 2 according to Myeloma Geriatric Assessment score
- 4. The following cardiac conditions: - New York Heart Association stage III or IV congestive heart failure. - Myocardial infarction or coronary artery bypass graft ≤6 months prior to enrollment. - History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration. - History of severe non-ischemic cardiomyopathy. - Impaired cardiac function (LVEF <45%) as assessed by echocardiogram or multiple-gated acquisition scan (performed ≤60 days prior to apheresis).
- 5. Grade 2 or higher ongoing non-hematologic toxicity due to induction therapy, with the exception of grade 2 peripheral neuropathy due to bortezomib.
- 6. Participants who require continuous supplemental oxygen.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States. 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 EU CTIS; the study team decides eligibility.