Phase 2 Myeloma Trial, Recruiting

Written by an AI model from the 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 are 65 years of age or older and have been diagnosed with multiple myeloma according to established international diagnostic standards, with measurable levels of the disease detectable through blood or urine tests at the screening stage.
• People whose general physical health and ability to carry out daily activities falls within a certain range, as measured by a standard medical scoring tool called the ECOG scale (scores 0–2, meaning fully active to capable of some self-care) (confirm with trial site).
• People who have not been considered suitable for high-dose chemotherapy followed by a stem cell transplant using their own cells.
• People whose blood and laboratory test results meet certain required levels during the screening phase (confirm with trial site for specific values).
• Male participants who agree to use a condom (with spermicidal foam, gel, film, cream, or suppository) during any activity that could pass ejaculate to another person, throughout the study and for at least 4 weeks after the last dose of one study drug (lenalidomide) or 3 months after the last dose of other study treatments, whichever is later — and whose female partner, if she is able to become pregnant, also uses a highly effective form of contraception (vasectomised male participants still need to use a condom, but their female partner is not required to use additional contraception).
• Male participants who agree not to donate sperm during the study and for at least 4 weeks after the last dose of lenalidomide or 3 months after the last dose of other study treatments, whichever is later.
• People who are willing and able to sign a consent form confirming they understand the study's purpose and procedures and agree to participate.
• People who are willing and able to follow the lifestyle requirements set out in the study plan.

Who may not be able to join:

• People whose multiple myeloma has spread to the brain or spinal fluid, or who show signs of this — unless a brain scan and spinal fluid test both come back negative.
• People diagnosed with certain related blood or plasma cell conditions, including plasma cell leukaemia, Waldenström's macroglobulinaemia, POEMS syndrome, or primary light chain amyloidosis.
• People who currently have a bone marrow disorder called myelodysplastic syndrome, or any other blood cancer (other than multiple myeloma).
• People who have a history of another cancer that is considered at high risk of coming back and would require ongoing systemic treatment.
• People who have had another active cancer (other than multiple myeloma) that has been progressing or required a change in treatment within the last 24 months.
• People who have had a stroke, mini-stroke (transient ischaemic attack), or seizure within the 6 months before signing the consent form.
• People with certain heart conditions (confirm with trial site for specific details).
• People with a chronic lung disease called COPD where lung function testing shows the lungs are working at less than 50% of the expected level for a healthy person of the same age.
• People with moderate or severe ongoing asthma in the past 2 years, or any asthma that is not well controlled — particularly where lung function testing shows less than 50% of the expected normal level.
• People who have had general radiotherapy within the past 14 days, or targeted (focal) radiation within the past 7 days.
• People who have received high cumulative doses of steroid medications (equivalent to 140 mg or more of prednisone) within the 14 days before the first study dose.
• People who have received a live or live-attenuated vaccine within 4 weeks before the first study dose (non-live vaccines, such as certain approved COVID-19 vaccines, are generally allowed).
• People who have previously received any treatment for multiple myeloma or a pre-cancerous related condition called smoldering myeloma, other than a short, limited course of steroid medication before signing the consent form.
• People who have a known severe allergy, intolerance, or life-threatening reaction to any of the drugs or ingredients used in this study.
• People who test positive for HIV.
• People with a hepatitis B infection.
• People with an active hepatitis C infection, confirmed by a specific blood test.
• Women who are able to become pregnant.
• People who have had major surgery or a significant injury within 2 weeks before starting study treatment, who have not fully recovered from surgery, or who have major surgery planned during the expected treatment period or within 2 weeks after the last study dose.
• People with an existing medical or mental health condition that is likely to interfere with study procedures or results.
• Male participants who plan to father a child while in the study or within 3 months after the last study dose.
• People who are under legal guardianship, trusteeship, or who have had their freedom restricted by a court or administrative decision.

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