Phase 2 Myeloma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older who have been diagnosed with multiple myeloma that has come back or stopped responding to treatment, confirmed using standard international criteria.
• People who have already received at least three rounds of treatment, including specific drug types (immune-modulating drugs, proteasome inhibitors including a drug called carfilzomib, and anti-CD38 antibody treatments), and whose disease either did not respond well enough to at least 2 cycles of carfilzomib-based treatment or came back while on that treatment.
• People (or their legal guardian) who are willing and able to sign a consent form voluntarily.
• People who are reasonably physically functional — rated at level 2 or below on a standard medical fitness scale (confirm with trial site).
• People whose blood counts, heart function, kidney function, and liver function meet minimum safety levels as determined by blood tests and heart imaging (confirm with trial site for specific values).
• People whose myeloma is measurable through blood or urine tests showing certain protein levels above set thresholds (confirm with trial site for specific values).
• People who have previously had a stem cell transplant using their own cells, provided they have fully recovered from it, it has been more than 60 days since the transplant, and their blood counts have recovered without the need for growth factor support.
• People who are willing to have a bone marrow biopsy at scheduled points during the study, or when medically necessary.
• People with a life expectancy of at least 6 months.
• People who are willing and able to use at least one reliable method of birth control throughout the study — options include complete abstinence, surgical sterilisation of a partner, a hormonal contraceptive used for at least 3 months before starting (combined with a barrier method during the study), a double-barrier method, or an intrauterine device combined with an additional contraceptive method.
• Women of childbearing potential must have a negative pregnancy test before starting the study (within 21 days prior to the first dose via blood test, and within 72 hours via urine test).
• Men must avoid donating sperm from the first day of the study until 90 days after the last dose.

Who may not be able to join:

• People whose myeloma produces very little or no measurable protein in the blood or urine (known as non-secretory or hyposecretory myeloma), or whose disease can only be measured by a specific blood test called serum free light chain.
• People with a condition called plasma cell leukaemia — though people who were previously treated for this may be considered at the investigator's discretion.
• People who currently have a condition called light chain amyloidosis alongside their myeloma.
• People whose myeloma has spread to the brain or central nervous system.
• People who are pregnant or breastfeeding.
• People who have a serious, active, or recurring infection (viral, bacterial, or fungal), or who have had a fever with low white blood cell counts within one week of starting the study.
• People who have previously had a bone marrow or stem cell transplant from a donor, or who have received a solid organ transplant (such as a kidney or liver).
• People with unstable chest pain (angina), irregular heart rhythms, or heart failure beyond a certain level of severity — specifically, people who feel fine at rest but experience significant symptoms such as fatigue, breathlessness, or chest pain with ordinary everyday activity.
• People who have had significant health problems in the past 6 months in areas such as kidney disease, nerve damage, psychiatric conditions, diabetes, immune system disorders, heart or lung disease, or liver disease, if the study doctor believes these would affect safe participation — cases involving recent treatment for these conditions will be assessed individually.
• People who have been taking part in another experimental treatment study within the 12 weeks before enrolling.
• People who have previously had an allergic reaction or intolerance to proteasome inhibitor drugs, including carfilzomib, bortezomib, or ixazomib.
• People whom the study doctor considers unsuitable for the trial based on their overall assessment.

Important: Always verify eligibility with the trial site directly before applying.