Phase 3 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 who have been newly diagnosed with multiple myeloma according to standard medical criteria.
• People who are generally well enough to carry out some daily activities (a health performance score of 0–2, or 3 only if the reduced score is due to pain).
• People whose multiple myeloma is classified as standard risk (not the highest-risk stage) based on specific blood test results and chromosome findings.
• People who have detectable levels of the abnormal proteins produced by myeloma, measured by specific blood or urine tests done within 28 days before joining.
• People who are willing and able to enrol in a mandatory safety monitoring program required for one of the study drugs (called RevREMS).
• People who are able to have a bone marrow sample taken, which will be sent to a specialist laboratory for testing.
• People whose kidney function, blood counts, and liver function meet the minimum levels required by the trial (confirmed by blood tests taken within 14 days before joining).
• People living with HIV, provided they are on effective treatment and their virus levels are undetectable within the 6 months before joining.
• People with a history of hepatitis B, provided the virus is undetectable on suppressive treatment.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with undetectable virus levels.
• People who have had or currently have another cancer, provided that cancer or its treatment is not expected to interfere with this trial's safety or results.
• People with a history of or current heart disease may be eligible if their heart function is rated at a certain level or better, and they have no currently uncontrolled heart conditions (confirm with trial site).
• People who have previously had blood clots in the legs or lungs, provided they are willing to take some form of blood-thinning medication as a preventive measure if not already on full-dose anticoagulation.
• People with a history of chronic obstructive pulmonary disease (COPD), provided a breathing test done within 28 days shows their lung function is above a certain level.
• People who have received no more than one cycle (up to 28 days) of prior chemotherapy and no more than a specified amount of steroid treatment (dexamethasone or equivalent) for myeloma before joining.
• People who have not previously been treated with daratumumab for myeloma.
• People who have had prior radiation therapy to affected areas, provided there are no ongoing side effects and at least 14 days have passed since treatment ended.

Who may not be able to join:

• People who have a known allergy or sensitivity to corticosteroids, monoclonal antibodies, human proteins, or products derived from mammals.
• Women who are pregnant or breastfeeding, or who are of childbearing potential and are not willing to use two accepted forms of contraception simultaneously throughout the study and for at least 3 months after the last dose, as required by the trial.
• Women of childbearing potential who are not willing to undergo pregnancy testing before and during treatment.
• Men who are not willing to use a latex condom during sexual contact with a person who could become pregnant throughout the study and for at least 3 months after the last dose, or who are not willing to abstain (even after a vasectomy).
• Anyone who is not willing to refrain from donating blood during the study and for at least 28 days after the last dose, or from donating sperm during treatment and for at least 3 months after the last dose.
• People who have moderate or severe persistent asthma within the past 2 years, or any asthma that is not well controlled.
• People who have significant nerve damage (peripheral neuropathy) rated at grade 2 or higher, or grade 1 with pain, at the time of joining.
• People with a serious medical or psychiatric condition that, in the treating doctor's opinion, could prevent them from completing the treatment.
• People who are receiving other chemotherapy or other experimental treatments at the same time as this trial.
• People entering the second phase of the trial (Step 2) who received any treatments outside the assigned trial treatment during Step 1, including a stem cell transplant.

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