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 who have been newly diagnosed with multiple myeloma, confirmed by a tissue sample (biopsy), with signs of the disease detectable in blood or urine tests taken within the past 4 to 8 weeks.
• People whose multiple myeloma has caused at least one sign of organ damage or disease-defining event, such as high calcium levels in the blood, low red blood cell counts (anaemia), bone damage with lesions, a high percentage of abnormal plasma cells in the bone marrow, or certain abnormal protein levels.
• Adults aged 18 or older.
• People who have a general health and activity level rated as reasonably functional (confirm with trial site for the specific rating scale used).
• People whose blood counts, liver function, and kidney function meet minimum levels set by the trial, tested within the past 45 days.
• People willing to enrol in a mandatory safety monitoring programme for one of the study drugs (lenalidomide), which involves specific rules around pregnancy prevention and medication access managed by the trial site.
• Women who could become pregnant must have a negative pregnancy test before starting the study and at regular points during it, and must agree to use at least one highly effective form of contraception throughout the study.
• Women who could become pregnant must agree not to donate or freeze eggs for assisted reproduction during the study and for at least 4 weeks after the last dose of lenalidomide, or 4 months after the last dose of elranatamab.
• Women must agree not to breastfeed during the study and for at least 4 weeks after the last dose of lenalidomide, or 4 months after the last dose of elranatamab.
• Men must agree to use a condom during any activity that could pass ejaculate to another person, throughout the study and for at least 4 weeks after the last dose of study treatment; if their female partner could become pregnant, that partner must also use a highly effective form of contraception.
• Men must agree not to donate sperm during the study and for at least 3 months after the last dose of study treatment.
• People who are able to understand the study and are willing to sign a consent form agreeing to take part.
• People who are willing and able to follow the lifestyle requirements set out in the study protocol.

Who may not be able to join:

• People who have already received more than one cycle of treatment for multiple myeloma (with some specific exceptions, such as short courses of steroids, bone-strengthening medications, or up to one cycle of any therapy within the past 60 days — confirm details with the trial site).
• People with known active involvement of multiple myeloma in the brain or spinal fluid.
• People who have had major surgery within the 14 days before joining the trial.
• People who have significant nerve damage (peripheral neuropathy) at a moderate-to-severe level or a history of it.
• People currently receiving other investigational (experimental) treatments for multiple myeloma.
• People who have received a live vaccine within 4 weeks before the planned start of study treatment.
• People who have a known allergy or reaction to any of the medications required as part of the study, including those used to prevent or treat side effects.
• People living with HIV who also have any of the following: a history of AIDS-defining conditions, a low CD4 immune cell count, a detectable level of HIV virus, not currently on effective HIV treatment, a recent change in HIV medication, or HIV medication that may interfere with study drugs.
• People with an active hepatitis B infection, or with hepatitis B virus DNA detected in their blood (certain people with past resolved hepatitis B infection may still be eligible — confirm with trial site).
• People with an active hepatitis C infection (people who have completed hepatitis C treatment and have no detectable virus for at least 12 weeks after finishing treatment may still be eligible — confirm with trial site).
• People with a serious lung condition (COPD) where breathing capacity is below 50% of the expected normal level.
• People with moderate-to-severe persistent asthma in the past 2 years, or asthma that is not well controlled, especially if breathing capacity tests fall below 50% of the expected normal level.
• People who test positive for COVID-19 (SARS-CoV-2) within 5 days before joining the trial, or who have a suspected active COVID-19 infection, or who have abnormal chest imaging.
• Women who are unwilling to stop breastfeeding during treatment or within 3 months after the last dose of study treatment.
• Men who plan to father a child while in the study or within 3 months after the last dose of study treatment.
• People with serious heart conditions, including severe heart failure, a heart attack or heart bypass surgery within the past 6 months, significant irregular heart rhythms, or unstable heart-related conditions.
• People with uncontrolled serious illnesses, including active infections, uncontrolled blood clots, active bleeding, lung scarring or inflammation, or active autoimmune diseases (some exceptions apply — confirm with trial site).
• People who have had another active cancer requiring treatment in the past 3 years (some exceptions apply for certain low-risk skin cancers or very early-stage cancers — confirm with trial site).
• People with active, uncontrolled bacterial, fungal, or viral infections; any active infection must have fully resolved at least 21 days before joining, and people who used systemic (whole-body) anti-infection medications within the past 28 days may not be eligible (routine preventive use may be permitted — confirm with trial site).
• People who are not able to make their own informed decisions about participating.

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