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 aged 18 or older (there is no upper age limit)
• People who have been newly diagnosed with multiple myeloma within the last 12 months and whose condition requires treatment to begin
• People whose test results and medical records are available to confirm their diagnosis and track how their disease responds to treatment
• People who meet their hospital's criteria to be considered suitable for a stem cell transplant using their own cells (called an autologous stem cell transplant, or ASCT)
• People who are generally in good physical condition and able to carry out daily activities without difficulty (described in medical terms as ECOG performance status 0–1)
• People who have already completed 16–24 weeks of initial (induction) treatment using three specific types of therapy together: a proteasome inhibitor, lenalidomide, and an anti-CD38 antibody drug, and whose disease responded at least partially to that treatment
• People whose disease showed measurable signs at the time of diagnosis, such as a certain level of abnormal protein in the blood or urine, or an imbalance in specific immune proteins called free light chains
• People whose cancer cells have a traceable genetic "fingerprint" that can be identified using a specialised test called ClonoSEQ®, allowing the trial to monitor remaining cancer cells over time
• People whose blood test results during the screening period meet specific minimum levels for red blood cells, platelets, white blood cells, liver function, kidney function, calcium, and bilirubin (confirm with trial site for exact values)
• People who have already completed the standard process of collecting their own stem cells for transplant (a minimum number of cells must have been collected, without using chemotherapy to stimulate collection)
• Women who are not able to become pregnant, or who agree to use reliable contraception and have a pregnancy test before starting treatment and during the study
• Women who agree not to donate or freeze eggs for reproductive purposes during the study and for 4 months after the last dose of treatment
• Men who agree to use a condom during the study and for at least 90 days after the last dose of treatment, and whose female partners of childbearing potential also use effective contraception
• Men who agree not to donate sperm during the study and for at least 90 days after the last dose of treatment
• People who are willing and able to follow the lifestyle requirements set out in the study plan
• People who are willing to sign a consent form confirming they understand the study and agree to take part
• People who agree to enrol in the required safety monitoring programmes for two of the study drugs: lenalidomide (Revlimid REMS) and elranatamab REMS

Who may not be able to join:

• People diagnosed with certain related but distinct blood or plasma cell conditions, including primary light chain amyloidosis, POEMS syndrome, Waldenström's macroglobulinemia, plasma cell leukaemia, or multiple myeloma that has spread to the brain or spinal fluid
• People who have a known serious allergy or intolerance to any of the drugs used in the trial
• People who have previously received any treatment targeting a protein called BCMA, or who have had gene-modified cell therapies such as CAR-T cell treatment
• People who have received certain other investigational drugs, experimental vaccines, live vaccines, radiation therapy, or chemotherapy within specified time periods before joining (confirm with trial site for exact timeframes)
• People whose previous treatments have not been stopped for long enough before joining (specific waiting periods apply for different drug types — confirm with trial site)
• People with known active cancer involvement in the brain or spinal fluid
• People with a bone marrow condition called myelodysplastic syndrome, or who have had another active cancer requiring treatment in the past 24 months — with some specific exceptions for certain cancers that have been completely cured (confirm with trial site for details)
• People who have had a stroke or seizure within the 6 months before signing the consent form
• People with severe chronic lung disease (COPD) where breathing test results fall below a specific threshold
• People with moderate to severe asthma that is not well controlled, or that has been difficult to manage in the past 2 years (people with mild, well-controlled asthma may still be considered)
• People who have previously had a bone marrow, stem cell, or solid organ transplant using cells or an organ from another person
• Women who are currently pregnant, breastfeeding, or planning to become pregnant during the study or within 6 months after the last dose of treatment
• Men who plan to father a child during the study or within 90 days after the last dose of treatment
• People with certain serious heart conditions, including severe heart failure, a recent heart attack or heart bypass surgery within the past 6 months, a history of significant irregular heartbeat or unexplained fainting, or a history of severe non-ischaemic heart muscle disease
• People with a history of HIV infection or AIDS-related illness
• People with a current or recent active infection (including COVID-19) that has not been fully resolved
• People with active hepatitis B or active hepatitis C infection (people who have been successfully treated for hepatitis C with no detectable virus for at least 12 weeks may still be considered — confirm with trial site)
• People who have had major surgery within 14 days before starting treatment, or who have not fully recovered from surgery, or who have major surgery planned during the study period
• People who cannot tolerate the supportive medications required as part of the study, with no alternative available
• People who cannot tolerate daratumumab or lenalidomide, or who had to reduce their lenalidomide dose to below 10 mg per day during induction treatment due to side effects
• People with significant nerve damage (neuropathy) causing moderate to severe symptoms
• People with a history of Guillain-Barré syndrome (a serious nerve condition)
• People with certain ongoing medical or psychiatric conditions that could interfere with the study, including uncontrolled diabetes, serious lung disease, a history of most autoimmune diseases, severe mental health conditions or cognitive impairment, alcohol or drug dependency, or a history of not following recommended medical treatment

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