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 aged 18 or older, of any gender
• People who have been newly diagnosed with multiple myeloma, are eligible for a stem cell transplant, and have completed at least four cycles of a four-drug treatment plan that includes an anti-CD38 antibody, and who received a high-dose stem cell transplant between 60 and 120 days ago (or up to 60 days after a follow-up consolidation treatment using the same drugs)
• People whose disease still shows signs of myeloma at a very sensitive level of detection (called MRD positive at 10⁻⁵, measured by a specific gene-based test), but whose overall response to treatment is at least a partial response
• People whose myeloma is not currently getting worse according to standard international guidelines
• People who are generally well enough to carry out daily activities, rated 0 or 1 on a standard health scale (ECOG); people rated 2 or 3 may also be considered if their limitations are due to a stable, unrelated physical condition — not from their myeloma or its treatment (confirm with trial site)
• People with adequate bone marrow function, including sufficient red blood cells, white blood cells, and platelets, measured within specific timeframes without recent transfusions or certain medications (confirm with trial site for exact values)
• People whose kidneys are working well enough, based on a standard calculation of kidney filtration rate (at least 30 mL/min)
• People whose liver is functioning adequately, based on standard blood tests for liver enzymes and bilirubin levels (with a specific exception allowed for people with a condition called Gilbert syndrome)
• People who are willing and able to follow the study's contraception and reproductive requirements for the duration of the study and for a set period after the last dose of study treatment, including using at least one highly effective method of contraception if there is any possibility of pregnancy; acceptable methods include hormonal contraception, intrauterine devices, surgical options, or reliable abstinence (confirm specific timeframes and requirements with trial site)
• People who have signed and dated a consent form and are willing to follow all study procedures for the full duration of the trial

Who may not be able to join:

• People who have recently received certain other treatments, including investigational drugs, targeted therapies, monoclonal antibodies, chemotherapy, specific myeloma drugs (such as proteasome inhibitors or immunomodulatory agents), radiation, or gene-modified cell therapies, within specified timeframes before the first study dose (confirm exact timeframes with trial site)
• People who have previously received a bispecific T-cell engager therapy or CAR T-cell therapy at any time
• People who have an active or suspected infection at the time of screening
• People with a known history or blood test evidence of HIV infection
• People with a known history or evidence of active hepatitis B or C virus infection (though people with successfully treated hepatitis C with no detectable virus for six months, or those with certain hepatitis B profiles who are on appropriate preventive treatment, may be considered — confirm with trial site)
• People with severe heart failure classified as Stage III or IV
• People with a clinically significant condition affecting the brain or central nervous system
• People with another active cancer that currently requires treatment
• People who are pregnant or breastfeeding
• People with a known allergy to any component of the study drugs (talquetamab or teclistamab)
• People who have received high cumulative doses of corticosteroid medications (equivalent to 140 mg or more of prednisone) within 14 days before the first study dose
• People who have received a live attenuated vaccine within four weeks before the first study dose
• People with certain specific blood or plasma cell disorders, including plasma cell leukaemia, smouldering multiple myeloma, Waldenström's macroglobulinaemia, POEMS syndrome, or primary light chain amyloidosis
• People with another active cancer diagnosed or requiring treatment changes in the last 24 months, with limited exceptions for certain cancers considered to be cured (such as specific types of non-invasive skin, cervical, bladder, breast, or prostate cancers — confirm with trial site)
• People who have had a stroke, mini-stroke (TIA), or seizure within the six months before enrolment
• People with significant heart conditions, including severe heart failure, a recent heart attack or unstable angina within six months, a history of serious heart rhythm problems or unexplained fainting, or uncontrolled heart rhythm abnormalities
• People who have had major surgery within two weeks before starting the study, have not fully recovered from surgery, or have major surgery planned during the treatment period or within two weeks after the last dose (minor procedures under local anaesthetic may be acceptable — confirm with trial site)
• People with other medical or psychiatric conditions that could interfere with the study or pose a safety risk, including active lung disease, active serious infections requiring treatment, active autoimmune disease requiring immune-suppressing medication within six months (with certain exceptions such as vitiligo, controlled type 1 diabetes, or stable thyroid conditions), severe psychiatric illness, dementia, or a history of not following recommended medical treatments

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