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 over 18 years of age.
• People who have been diagnosed with Multiple Myeloma (a type of blood cancer affecting plasma cells in the bone marrow), confirmed by bone marrow testing or a tissue biopsy, and whose disease meets at least one specific marker of severity — such as high calcium levels in the blood, reduced kidney function, low red blood cell counts (anaemia), or bone damage visible on scans.
• People whose myeloma can be measured through at least one of the following blood or urine tests: a protein called M-protein detected in urine or blood above a certain level, or an abnormal level of specific proteins called free light chains in the blood.
• People who are not suitable for high-dose chemotherapy followed by a stem cell transplant, due to other significant health conditions (such as heart, lung, or other major organ problems) that make that treatment too risky — assessed using a recognised scoring tool that takes into account age, health conditions, and physical and mental function.
• People with a general health and activity level rated as fully active, restricted in physically demanding activity but able to carry out light work, or up to being capable of self-care but unable to carry out any work (confirm with trial site for exact rating scale used).
• People whose blood counts, liver function, and kidney function meet minimum levels set by the trial (confirm with trial site for exact values).
• Female participants who are not pregnant, not breastfeeding, and who either are not able to become pregnant (based on age, surgical history, or confirmed menopause) or who agree to use two reliable methods of contraception throughout the trial and for a defined period after treatment ends — and who agree not to donate eggs during this time.
• Female participants who are able to become pregnant must have two negative pregnancy tests before treatment begins.
• Male participants who agree to use contraception (including a condom even after vasectomy) and to refrain from donating sperm during the trial and for a defined period after the last dose of study medication.
• People who are able to understand what the study involves and are willing to give written consent to participate.

Who may not be able to join:

• People who have previously received any systemic (whole-body) treatment for Multiple Myeloma or for smouldering myeloma (a pre-active form of the disease). A short emergency course of steroids or limited targeted radiation before joining may be acceptable (confirm with trial site).
• People who have nerve damage or nerve pain (called peripheral neuropathy) rated at a moderate level or above.
• People who have had major surgery within two weeks before the first dose of study treatment.
• People with an active kidney condition, such as a current kidney infection or a need for dialysis (though kidney-related protein leakage caused by the myeloma itself may still be acceptable — confirm with trial site).
• People with serious unstable medical or psychiatric conditions that could affect their safety or ability to follow study procedures.
• People with active uncontrolled internal or mucosal bleeding not explained by a reversible clotting problem.
• People with active liver or bile duct disease (some stable or minor liver conditions may be acceptable — confirm with trial site).
• People who have had or currently have another type of cancer, unless it was surgically treated cervical cancer in situ, a non-melanoma skin cancer that was cured, or another cancer that has been medically stable for at least two years and is not being actively treated (hormonal therapy for that other cancer may be permitted — confirm with trial site).
• People with certain heart rhythm problems, a recent heart attack, recent coronary procedures, or unstable heart conditions within three months before screening.
• People with severe heart failure (Class III or IV, as rated by a recognised heart failure classification system).
• People with uncontrolled high blood pressure.
• People with an active infection currently requiring treatment.
• People with HIV, unless the infection is well controlled on established anti-HIV medication with specific blood count and viral load results meeting defined thresholds, and no recent serious HIV-related illness (confirm with trial site).
• People who test positive for active hepatitis B infection. People with past hepatitis B exposure must have additional testing, and those who test positive on that further test will not be eligible.
• People who test positive for hepatitis C, unless the infection has been successfully treated and a follow-up test confirms the virus is no longer detectable (confirm with trial site).
• People with active corneal (eye surface) disease, except for a mild specific form called mild punctate keratopathy.
• People who cannot tolerate anti-viral preventive medication required as part of the trial.
• People who cannot tolerate blood-clot prevention medication required as part of the trial.
• People who have a related condition called AL amyloidosis, active POEMS syndrome, or active plasma cell leukaemia at the time of screening.
• People who have signs or a known history of myeloma spreading to the brain or central nervous system.
• People who have had a serious allergic reaction to any drug chemically similar to the study medications, or to any component of the study treatment.
• People who have taken another experimental drug within 14 days (or within a specific time based on that drug's half-life, whichever is shorter) before the first dose of study treatment.
• People who have had plasmapheresis (a blood-filtering procedure) within seven days before the first dose of study treatment.
• People with active, inadequately controlled bowel disease, including uncontrolled diarrhoea.
• People with uncontrolled skin disease.
• People with persistently low levels of certain minerals in the blood (phosphate, potassium, or magnesium) that cannot be corrected with supplements.
• People who have previously been treated with a type of drug called a gamma secretase inhibitor.
• People who are currently taking certain medications that strongly affect how the body processes other drugs (specifically, strong or moderate CYP3A4 inhibitors or inducers — confirm with trial site).
• People who have received a live or live-attenuated vaccine within 30 days before the first dose of the study treatment.
• People who wear contact lenses (contact lenses must not be worn while receiving one of the study drugs).
• People who are unable or unwilling to follow the pregnancy prevention programme required for one of the study medications (lenalidomide) in their region.

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