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:

• People diagnosed with multiple myeloma who have previously received induction treatment that included the drug daratumumab (for at least 3 cycles) and whose disease responded at least partially to that treatment.
• People who completed an autologous stem cell transplant (a procedure using the patient's own stem cells) between 90 and 150 days before joining the trial, with no further treatment after the transplant and no sign that the disease got worse after the transplant.
• People whose myeloma is still detectable at a very sensitive level (called MRD positive, meaning small amounts of cancer cells can still be found using a specialised test called clonoSEQ) at the time of joining the trial.
• People whose general physical functioning is rated at a level of 0, 1, or 2 on a standard medical scale (meaning they are able to carry out at least some daily activities) (confirm with trial site).
• People whose blood counts are within acceptable ranges — including platelets, red blood cells, and white blood cells — tested within 28 days before joining. A blood transfusion to meet the red blood cell level is allowed.
• People whose liver is functioning within acceptable limits, based on blood tests taken within 28 days before joining.
• People whose kidneys are functioning at an acceptable level, based on a measurement of how well the kidneys filter waste, tested within 28 days before joining.
• People who have recovered from most side effects of the stem cell transplant before joining (minor ongoing effects like hair loss, tiredness, or changes to menstrual periods are acceptable).
• Women who could become pregnant must have a negative pregnancy test within 10–14 days before joining, and again within 24 hours before starting treatment, and must agree to use two forms of contraception throughout the trial and for a set period after treatment ends.
• Men must agree to use a condom during sexual contact with a partner who could become pregnant throughout the trial and for 90 days after the last dose of treatment.
• People aged 18 or older.
• People who have been fully informed about the nature of the trial and have signed a written consent form.

Who may not be able to join:

• People with active HIV or hepatitis C (where the virus is currently detectable in the blood).
• People who test positive for active hepatitis B infection, or who have evidence of past hepatitis B infection with the virus still detectable by a specialised DNA test. (People whose only positive hepatitis B marker is from a previous vaccination do not need further testing.)
• People whose MRD status cannot be assessed at the time of joining, or who test MRD negative at the required sensitivity level.
• People who have had a heart attack or stroke within 90 days before joining.
• People who are unable to take the required preventive medications against blood clots or viral infections.
• People who have had major surgery within 28 days before joining.
• People with a medical, neurological, or psychiatric condition that would make it unsafe to follow the trial treatment plan, including certain serious heart conditions.
• People who previously had to stop daratumumab treatment because of serious side effects from that drug.
• People with a history of another cancer (other than multiple myeloma), unless all treatment for that cancer was completed at least 2 years before joining and there is no current evidence of that cancer. Certain low-risk skin cancers or non-invasive conditions may be exceptions (confirm with trial site).
• People showing signs that multiple myeloma has spread to the brain or spinal fluid.
• People with a known lung condition called COPD where lung function (measured by a breathing test) is below 50% of what would normally be expected.
• People with moderate or severe asthma that has been present in the past 2 years, or any asthma that is currently not well controlled. People with mild, well-controlled asthma may be eligible provided their lung function test result is at an acceptable level.
• People who have had a heart attack within 6 months before joining, or who have an unstable or uncontrolled heart condition, including certain types of heart failure or irregular heartbeat.
• People with known allergies or serious sensitivities to any of the study drugs or their ingredients, including related drugs such as lenalidomide, thalidomide, or pomalidomide.
• People who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the trial or within 90 days after the last dose of treatment. Male participants planning to father a child during the trial or within 90 days after the last dose are also excluded.
• People whose heart's electrical activity (measured by an ECG) shows a certain type of prolonged interval beyond the accepted threshold.
• People who have recently been taking certain medications that strongly affect how the body processes drugs (specific enzyme and drug-transporter interactions) within 14 days or 5 half-lives before starting trial treatment, whichever is shorter (confirm specific medications with trial site).

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