Trial studying safety and effects for Multiple Myeloma
Official title A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel
ClinicalTrials.gov ID: NCT07149857
What this study is testing
What is Cilta-cel?
This is an investigational cell therapy being studied as a potential treatment for multiple myeloma. It is designed to use your own immune cells, which are modified in a lab to better recognize and attack cancer cells.
Also referred to as JNJ-68284528.
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 study aims to find out how well and how safely ciltacabtagene autoleucel works when given after two different chemotherapy regimens that lower white blood cells.
- Who it's for
- Adults who have multiple myeloma and are eligible for the study’s treatment plan.
- What's involved
- Participants will receive a chemotherapy regimen to reduce certain white blood cells, followed by an infusion of ciltacabtagene autoleucel, with follow‑up visits and tests to monitor safety and effectiveness.
- 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 80
You may be able to join if
- Documented diagnosis of newly diagnosed multiple myeloma (NDMM) according to the most recent international myeloma working group (IMWG) diagnostic...
- Not considered a candidate for high-dose chemotherapy with stem cell transplantation due to: (a) Advanced age
- Participant must have received at least 3 cycles and no more than 5 cycles of induction therapy.
- Eastern cooperative oncology group (ECOG) Performance Status score of 0 or 1
- Must be willing and able to adhere to the lifestyle restrictions specified in the protocol
You likely can't join if
- Frailty index of \>= 2 according to Myeloma Geriatric Assessment score
- Known allergies, hypersensitivity, or intolerance to study intervention or its active agents
- Grade 2 or higher ongoing non-hematologic toxicity due to induction therapy, with the exception of grade 2 peripheral neuropathy due to bortezomib
- Participants who require continuous supplemental oxygen
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
- Winston-Salem, North Carolina, United States
- Cleveland, Ohio, United States
- Camperdown, Australia
- Clayton, Australia
- Heidelberg, Australia
- Murdoch, Australia
- Woolloongabba, Australia
- Badalona, Spain
- Barcelona, Spain
- Madrid, Spain
- Pamplona, Spain
- Salamanca, Spain
- Santander, Spain
- Seville, Spain
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, but 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States; Winston-Salem, North Carolina, United States; Cleveland, Ohio, United States; Camperdown, Australia; Clayton, Australia; Heidelberg, Australia and 9 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.