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) who have been newly diagnosed with multiple myeloma and whose doctors have determined that treatment should begin.
• People whose multiple myeloma is measurable through specific blood, urine, or protein tests at the time of screening (confirm with trial site for exact values).
• People who are generally well enough to carry out daily activities, as assessed using a standard medical scale (ECOG performance status 0–2 — confirm with trial site).
• People who have had little or no prior treatment for multiple myeloma — limited early treatment with dexamethasone, bortezomib, cyclophosphamide, or lenalidomide may be acceptable if given within the 4 weeks before joining, within specific dose limits (confirm with trial site).
• People whose blood counts, kidney function, liver function, and calcium levels meet the required ranges during screening (confirm with trial site for exact values).
• Women who are not able to become pregnant, or women who are able to become pregnant and who agree to use reliable contraception, avoid donating or freezing eggs, and have a negative pregnancy test before and at the start of treatment.
• Men who agree to use a condom during the study and for at least 90 days after their last dose, and who agree not to donate sperm during that time.
• People who are willing and able to follow all study lifestyle rules and sign a consent form agreeing to participate.
• People who meet their own treatment centre's requirements for eligibility for a stem cell transplant, as assessed by the trial doctor.
• People who are willing to be enrolled in the Revlimid REMS™ programme, which is a required safety programme linked to one of the study medications.
• The trial specifically aims for at least 25% of enrolled participants to be from ethnic minority groups, in recognition of the higher rates of multiple myeloma in Black populations and the historical underrepresentation of ethnic minorities in myeloma trials.

Who may not be able to join:

• People diagnosed with certain related blood or plasma cell conditions, including plasma cell leukaemia, primary light chain amyloidosis, POEMS syndrome, or Waldenström's macroglobulinaemia.
• People who have a known serious allergy or intolerance to any of the study drugs or their ingredients.
• People who have previously received teclistamab or any other anti-BCMA therapy, or daratumumab or any other anti-CD38 therapy.
• People who have recently received certain other treatments, including investigational drugs, live vaccines, radiotherapy, gene-modified cell therapies, or other cancer medicines, within specific timeframes before joining (confirm with trial site for exact timeframes).
• People with known active spread of multiple myeloma to the brain or nervous system.
• People with another active cancer that has been progressing or required a change in treatment within the last 24 months — some exceptions apply for certain fully treated and cured cancers (confirm with trial site).
• People who have had a stroke or seizure within 6 months before signing the consent form.
• People with a serious lung condition called COPD where breathing test results fall below a certain level (confirm with trial site).
• People with moderate-to-severe persistent asthma in the past 2 years, or asthma that is not well controlled — mild or well-controlled asthma may be acceptable (confirm with trial site).
• People who have previously had an allogeneic (donor) bone marrow, stem cell, or solid organ transplant.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study or within 90 days after the last dose of study treatment.
• Men who are planning to father a child during the study or within 90 days after the last dose of study treatment.
• People with certain serious heart conditions, including severe heart failure, a heart attack or heart bypass surgery within the past 6 months, a history of significant heart rhythm problems, or severe heart muscle disease (confirm with trial site).
• People who are known to have HIV, active hepatitis B, or active hepatitis C infection.
• People who have had major surgery within 2 weeks before starting treatment, or who have major surgery planned during the study period.
• People with significant nerve damage (neuropathy) at a certain severity level within 21 days before registering (confirm with trial site).
• People with uncontrolled diabetes, active serious lung disease, an active infection requiring treatment, or certain autoimmune conditions — some autoimmune conditions may be acceptable (confirm with trial site).
• People with serious psychiatric conditions, severe dementia, alcohol or drug misuse problems, or a history of not following recommended medical treatment.
• People with any other medical or mental health condition that the trial doctor believes would make participation unsafe or interfere with the study.

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