Actively Recruiting
CAR-T Cell Therapy in RelApsed/Refractory Myeloma With ExtrameduLlary Disease - an in Vivo Imaging and Molecular Monitoring Study
Led by Peter MacCallum Cancer Centre, Australia · Updated on 2024-04-11
10
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
P
Peter MacCallum Cancer Centre, Australia
Lead Sponsor
J
Janssen, LP
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial will investigate the in vivo trafficking of cilta-cel in extramedullary myeloma using 64Cu Super Paramagnetic Iron Oxide Nanoparticle (64Cu SPION) and Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI)
CONDITIONS
Official Title
CAR-T Cell Therapy in RelApsed/Refractory Myeloma With ExtrameduLlary Disease - an in Vivo Imaging and Molecular Monitoring Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has provided written informed consent
- Patient is >18 years of age at the time of consent
- Documented diagnosis of multiple myeloma according to IMWG criteria
- Measurable extramedullary disease by imaging, with at least one lesion 7 mm not previously irradiated or progressing after radiotherapy
- Have received at least 2 prior lines of therapy including a proteasome inhibitor and an immunomodulatory drug, with at least one complete cycle per line unless progression was best response
- ECOG Performance Status of 0 or 1
- Life expectancy of at least 3 months as judged by Investigator
- Able to undergo apheresis for mononuclear cell collection
- Clinical laboratory values within 7 days prior to enrollment: haemoglobin 80 g/L, ANC 1 x 10^9/L, platelet count 5 x 10^9/L, absolute lymphocyte count 0.3 x 10^9/L, AST and ALT 3 x upper limit normal, total bilirubin 2 x upper limit normal (with exceptions for Gilbert's syndrome), creatinine clearance 40 mL/min
- Women of childbearing potential must commit to abstinence or use two reliable methods of contraception from consent until 1 year post-infusion
- Men must commit to abstinence or use barrier contraception from consent until 1 year post-infusion
- Women and men must agree not to donate eggs or sperm until 1 year after cilta-cel infusion
- Willing and able to follow study lifestyle restrictions and prohibited therapies
You will not qualify if you...
- Known sensitivity to nickel or palladium
- Weight over 105 kg or height over 185 cm
- Known claustrophobia
- Prior treatment with any CAR-T therapy
- Use of corticosteroids equivalent to 70 mg prednisone within 7 days prior to planned apheresis
- Prior therapies targeting BCMA
- Vaccination with investigational or live attenuated vaccine (except COVID-19) within 4 weeks before planned conditioning
- Recent anti-tumor therapies prior to apheresis including targeted, epigenetic, investigational drugs within 14 days, monoclonal antibodies within 21 days, cytotoxic therapy within 14 days, or radiotherapy within 14 days (with some exceptions)
- Active malignancies other than the study disease unless treated and considered cured within 24 months
- Plasma cell leukemia at screening, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis
- Known allergies or intolerance to study treatments or their components
- Pregnant, breastfeeding, or planning pregnancy during study or within 1 year post-infusion
- Plans to father a child during study or within 1 year post-infusion
- Stroke or seizure within 6 months prior to consent
- Recent stem cell transplant or active graft-versus-host disease
- Known or suspected central nervous system involvement of multiple myeloma
- HIV positive, active or unresolved hepatitis B or C infection
- Serious medical or psychiatric conditions interfering with study participation
- Major surgery within 2 weeks before bridging therapy or planned during study
- Frailty index of 2 or higher according to Myeloma Geriatric Assessment
- Any condition impairing ability to tolerate treatment or understand consent as judged by Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
Research Team
S
Simon Harrison
CONTACT
M
Mark Dowling
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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