Phase 1 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 diagnosed with multiple myeloma, confirmed through a tissue or cell sample test.
• People who have had a stem cell transplant using their own cells (autologous) must have had that transplant more than 100 days before joining the study.
• People whose myeloma has come back or stopped responding to treatment after at least 4 previous treatment regimens, which must have included at least one drug from each of these three groups: a proteasome inhibitor (such as bortezomib, carfilzomib, or ixazomib), an immunomodulatory drug (such as thalidomide, lenalidomide, or pomalidomide), and an anti-CD38 antibody treatment (such as daratumumab or isatuximab).
• People whose myeloma can be measured through specific blood, urine, or laboratory tests (certain levels of proteins in the blood or urine, or abnormal light chain levels); people with a type of myeloma that does not produce measurable proteins may also be considered.
• People aged 18 or older.
• People who are reasonably able to carry out daily activities, as assessed by a standard medical scoring system (confirm with trial site).
• People with blood counts and organ function results within acceptable ranges on tests done within the past 28 days, without recent reliance on certain medical support treatments (confirm with trial site for specific values).
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.
• People with chronic hepatitis B virus infection whose viral load is undetectable while on appropriate treatment.
• People who previously had hepatitis C virus infection and have been successfully treated and cured, or who are currently on treatment with an undetectable viral load.
• People who have had brain metastases that were previously treated, where follow-up brain scans taken at least 28 days after that treatment show no sign of the disease growing.
• People with new or worsening brain involvement, where the treating doctor determines that urgent brain-specific treatment is not needed during the first cycle of this trial.
• People who have had or currently have another type of cancer, as long as that cancer or its treatment is not expected to interfere with this trial's safety or results.
• People with a history of heart disease or treatment with heart-affecting medications may be eligible if a medical assessment places their heart function in Class II or better on a standard heart health scale (confirm with trial site).
• Women of childbearing potential who commit to using two forms of contraception (one highly effective and one additional method) starting at least 28 days before taking iberdomide and continuing for 28 days after stopping, and who agree to pregnancy testing before and during the study.
• Male participants who agree to use a condom during any sexual contact with a woman who could become pregnant, throughout the study and for at least 28 days after stopping treatment.
• All participants who agree not to donate blood products while taking iberdomide and for at least 28 days after the last dose.
• Male participants who agree not to donate semen or sperm while taking iberdomide and for at least 28 days after the last dose; women of childbearing potential who agree not to donate eggs during this period.
• People who are willing and able to sign a consent form (or have a legally authorised representative do so on their behalf).
• People who are willing to follow the study schedule, attend follow-up visits at the enrolling site, and provide required blood and bone marrow samples for research purposes.

Who may not be able to join:

• People who currently have active plasma cell leukaemia, active AL amyloidosis, active POEMS syndrome, or Waldenström macroglobulinaemia.
• People who have previously been treated with an anti-BCMA bispecific antibody (prior anti-BCMA antibody-drug conjugates, anti-BCMA CAR T-cell therapy, or non-BCMA-targeting bispecific antibodies are permitted).
• People who have previously been treated with a cereblon E3 ligase modulator, including mezigdomide, iberdomide, or CFT7455.
• People who received a plasmapheresis procedure within 7 days before joining the study.
• People who have previously had a stem cell transplant using donor cells (allogeneic transplant).
• People who received a live or live-attenuated vaccine within 30 days before joining (COVID-19 vaccines are permitted at any point during the trial).
• People who currently have an active infection requiring treatment.
• People who still have unresolved side effects of grade 2 or higher from previous treatments, except for hair loss or nerve-related symptoms up to grade 2.
• People who have had major surgery within 4 weeks before joining the study.
• People with other serious uncontrolled health conditions that would make participation in this trial unsafe.
• People with signs of active bleeding from internal areas or mucous membranes.
• People with unstable liver or bile duct disease, including certain serious liver-related complications (confirm with trial site for specific conditions); stable chronic liver conditions may be acceptable.
• People who have had a known allergic or severe sensitivity reaction to teclistamab, iberdomide, or any of the other study treatment components.
• People who are currently receiving any other cancer treatment, other than hormonal therapy for prostate or breast cancer, or limited palliative radiotherapy to no more than 3 sites.
• People who require immune-suppressing medications, including steroid medications at doses above the equivalent of 10 mg per day of prednisone (certain exceptions apply — confirm with trial site).
• People who need to take medications that are strong inhibitors or inducers of a specific liver enzyme called CYP3A4/5 (confirm with trial site for specific drug examples).
• People who are currently participating in another clinical trial involving an investigational treatment.
• People who are pregnant, as one of the study drugs (iberdomide) is related to thalidomide, which is known to cause serious harm to a developing baby.
• People who are breastfeeding, due to potential risks to nursing infants.
• People who are unable or unwilling to follow the blood clot prevention measures required by the study.

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