Printed from Voxsanity (voxsanity.com.au) — NCT07665307 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Myeloma
Myeloma Trial, Recruiting
NCT07665307
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who are 18 years of age or older at the time of signing the consent form.
- People who are able to understand and are willing to sign a consent form before any study-related activities take place.
- People who are willing and able to attend study visits and follow the study requirements.
- People who have a confirmed diagnosis of multiple myeloma and whose treating doctor has determined them to be eligible for the commercially available CAR-T cell therapy called cilta-cel — including people whose cell product did not fully meet manufacturing standards but whose doctor is still planning to proceed with the infusion.
- People whose physical functioning is rated at ECOG Performance Status 2 or below, meaning they are able to care for themselves and are up and about for more than half of waking hours (confirm with trial site).
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have been diagnosed with certain related but distinct blood or plasma cell conditions, including monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma, primary amyloidosis without active multiple myeloma, Waldenström's macroglobulinemia, or POEMS syndrome.
- People with active plasma cell leukemia, where a significant number of abnormal plasma cells are found circulating in the blood.
- People whose multiple myeloma has spread to the central nervous system (the brain or spinal cord).
- People with certain heart conditions, including severe heart failure (New York Heart Association class 3 or 4), a heart attack or heart bypass surgery within the last 6 months, a history of significant irregular heart rhythms, or a history of severe non-ischemic cardiomyopathy (a type of heart muscle disease).
- People who have had a stroke or seizure within the 6 months before enrolling.
- People with a serious medical condition, abnormal lab result, or psychiatric illness that would prevent them from signing the consent form.
- People with serious ongoing medical conditions that the treating doctor or study investigator believes could make the study unsafe or make it difficult to assess results.
- People with an active hepatitis B or hepatitis C infection confirmed by a PCR test (people with blood test results suggesting past exposure will need further PCR testing before a decision is made).
- People who test positive for HIV.
- People who have or have had another cancer, except in specific circumstances — including adequately treated skin cancers or early-stage cancers that have been fully treated and considered cured, certain low-risk or treated prostate, cervical, or breast cancers meeting specific criteria, or any other cancer from which the person has been disease-free for more than 3 years or is considered cured with minimal risk of return (confirm details with trial site).
- People who have previously received any CAR-T cell therapy.
- People who have previously had an allogeneic stem cell transplant (a transplant using donor cells).
- People who have had major heart surgery within 8 weeks before the cilta-cel infusion, or any other major surgery within 4 weeks before the infusion.
- People who are pregnant or breastfeeding.
- People whose blood test results fall outside certain thresholds, including low white blood cell counts, low platelet counts, poor kidney function, elevated liver values, or high blood calcium levels (confirm specific thresholds with trial site).
- People who are prisoners or who are being held in a detention facility involuntarily.
- People who are being compulsorily detained for treatment of a psychiatric or physical illness.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
Contact this trial
Principal Investigator: Samir Parekh, Professor , MD/PHD, Mount Sinai
Phone: 347.835.3446
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
10 July 2026
Est. completion
18 June 2029
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Cilta-cel peak expansion (Cmax); Cilta-cel peak expansion (Cmax)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.