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 are 18 years of age or older (or the minimum legal age required in the country where the trial is taking place) at the time of signing the consent form
• People who have been formally diagnosed with multiple myeloma (MM) according to established international diagnostic guidelines
• For the teclistamab or talquetamab + tocilizumab treatment groups: people who have already received 2 or more previous MM treatments, including one from each of three specific drug types — a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and a CD38 antibody
• For the teclistamab + oral dexamethasone treatment group: people who have already received at least 1 previous MM treatment, including at least one drug from any of those three drug types
• For the teclistamab or talquetamab + tocilizumab groups: people whose general physical functioning is rated at 0 or 1 on a standard medical scale (meaning fully active or able to do light work), and for the teclistamab + dexamethasone group, rated 0, 1, or 2 (meaning up and about more than half of waking hours) (confirm with trial site)
• People whose myeloma is measurable through blood or urine tests, or through detectable tumour masses of at least 2 cm, at the time of screening
• People living with HIV, provided their viral load is undetectable (fewer than 50 copies per millilitre), their immune cell count is above a certain level, they have had no serious HIV-related infections in the past 6 months, and they are on an established anti-HIV medication regimen
• People whose organs (such as kidneys, liver, and heart) are functioning at an adequate level
• People who weigh more than 35 kg
• People who are able to become pregnant must have a negative pregnancy test at screening and again within 72 hours before starting treatment, and must agree to ongoing pregnancy testing during the study
• People who agree to follow the contraception requirements set out in the study protocol for the full duration of the trial, including avoiding donating eggs or sperm for a specified period
• People who are willing and able to sign a consent form confirming they understand the study and agree to take part
• People who can stay within 60 minutes' travel of the trial site and remain with a responsible adult at all times until 48 hours after each teclistamab step-up dose
• People who can stay within 30 minutes' travel of the trial site and remain with a responsible adult at all times until 48 hours after each talquetamab step-up dose
• People who agree to carry a study identification wallet card at all times during the trial
• People who are willing to measure and record their body temperature and blood oxygen levels twice daily (at least 8 hours apart) during the first two treatment cycles, and to attend the study site for required safety check-ups
• People (and their accompanying responsible adult) who are willing to learn the warning signs of possible treatment-related side effects, and whose accompanying adult agrees to watch over them for the first 48 hours after the first treatment dose

Who may not be able to join:

• People whose myeloma is rapidly getting worse, as assessed by the treating doctor
• People who have plasma cell leukaemia, Waldenström's macroglobulinaemia, POEMS syndrome, or primary amyloid light-chain amyloidosis
• People who have myeloma that has spread to the brain or spinal cord, or who show signs of this
• People considered at risk of a serious condition called tumour lysis syndrome (TLS) that would require special medical management
• People who have myelodysplastic syndrome or another active cancer (one that has been progressing or required a treatment change in the last 12 months), with some specific exceptions for certain low-risk or stable cancers (confirm with trial site)
• People who have severe blood-related side effects or other serious clinically significant health problems at the time of enrolment
• People who currently have a fever or an active bacterial, viral, or uncontrolled fungal infection at the time of enrolment
• People with an active autoimmune disease or a documented history of autoimmune disease, with exceptions for vitiligo, type 1 diabetes, and a past thyroid condition that is currently well controlled
• People with a significant blood-clotting disorder that could increase the risk of bleeding
• People experiencing a worsening of neurological symptoms, including confusion or unusual drowsiness
• People with psychiatric conditions (such as significant alcohol or drug problems), dementia, or altered mental state that could affect the ability to consent or follow the study requirements
• People who have had a stroke, mini-stroke (TIA), or seizure within the 6 months before signing the consent form
• People with certain serious heart conditions, including severe heart failure, a heart attack or bypass surgery within the past 6 months, a history of serious heart rhythm problems or unexplained fainting, severe non-ischaemic cardiomyopathy, poorly controlled coronary artery disease or heart failure, or uncontrolled heart rhythm problems
• People who have active hepatitis B infection
• People who have active hepatitis C infection (people with a past hepatitis C infection who have completed antiviral treatment and have had no detectable virus for at least 12 weeks after finishing treatment may still be eligible — confirm with trial site)
• People with chronic obstructive pulmonary disease (COPD) where lung function is measured at less than 50% of the expected level
• People with severely reduced kidney function (eGFR below 20 ml/min) or who are on dialysis
• People with any other medical condition that, in the treating doctor's judgement, would make participation unsafe, prevent them from completing the study requirements, or not be in their best interest
• For the talquetamab group only: people who have previously had a severe (Grade 3 or higher) immune reaction called cytokine release syndrome (CRS) related to a T-cell redirecting therapy or CAR-T cell therapy, or who have previously received any therapy targeting a protein called GPRC5D
• People who have received red blood cell or platelet transfusions within the 7 days before starting the study drug
• People for whom tocilizumab or intravenous immunoglobulin (IVIG) are medically unsuitable based on standard prescribing guidelines
• People who have received a live vaccine within 1 month before screening, or who plan to receive a live vaccine during the trial
• People who have received a live attenuated vaccine within 30 days before the first study dose (live attenuated influenza vaccines are permitted up to 30 days before treatment)
• People who have taken part in another non-cancer investigational study or used an investigational medical device within 21 days before the planned first dose, or received an investigational biological product within 21 days or 5 half-lives (whichever is shorter), or who are currently enrolled in another investigational study
• People who have received certain recent cancer treatments before the first study dose, including targeted therapy, monoclonal antibody therapy, chemotherapy, immunomodulatory drugs, proteasome inhibitors, or radiotherapy, depending on specific timeframes for each (confirm with trial site)
• For the teclistamab groups only: people who have previously received gene-modified cell therapies (such as CAR-T cells) or BCMA-targeting therapy
• For the talquetamab group only: people who have received gene-modified cell therapies within the past 3 months, or BCMA-targeting therapies within 21 days or 5 half-lives (whichever is shorter)
• People who have had an allogeneic (donor) stem cell transplant within the past 6 months, or who are still on immunosuppressive medications or showing signs of graft-versus-host disease
• People who have had an autologous (own cells) stem cell transplant within 12 weeks before the planned first study dose

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