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 willing to give written consent to participate, with the understanding that they may withdraw from the trial at any time without affecting their future medical care.
• People aged 18 or older, of any gender.
• People who, according to their treating institution's guidelines, are considered suitable candidates for high-dose therapy followed by a stem cell transplant using their own stem cells.
• People who have received little to no prior treatment for multiple myeloma — only limited, short-term use of dexamethasone, bortezomib, or cyclophosphamide (within specific dose limits, for no longer than four weeks before joining) may be allowed, and only if given to manage urgent symptoms.
• People with a confirmed diagnosis of multiple myeloma, including having at least 10% abnormal plasma cells in the bone marrow (or a biopsy-confirmed tumour), plus signs of organ damage or other defining disease features, and a measurable level of abnormal protein in the blood or urine (confirm specific thresholds with trial site).
• People with a general health and activity level rated 0, 1, or 2 on a standard medical performance scale, meaning they are able to carry out daily activities with no more than moderate limitation (confirm with trial site).
• Women who are past menopause (for at least one year), have had a surgical procedure that means they cannot become pregnant, or who agree to use effective contraception starting two weeks before the first study treatment and continuing until 16 weeks after the last dose.
• Women who agree not to donate eggs from two weeks before the first study treatment until 16 weeks after the last dose.
• Men who agree to use effective barrier contraception or practise complete abstinence from the time of signing consent until 16 weeks after the last dose of study treatment — this applies even to men who have had a vasectomy.

Who may not be able to join:

• People in the kidney-impaired group who need immediate treatment for kidney failure, such as dialysis, at the time of enrolment (though this may be reconsidered once their condition is stable, at the investigator's discretion).
• People who have been diagnosed with or treated for another cancer, unless it was treated with the intent to cure and there has been no known active disease for at least 3 years, or it was a certain type of treated skin cancer or pre-cancerous condition with no current signs of disease.
• People who show signs of, or have a known history of, multiple myeloma affecting the brain or spinal fluid.
• People known to be HIV positive, to have active hepatitis B, or to have untreated or active hepatitis C.
• People with another ongoing medical condition or active infection that is likely to interfere with the study, or that the investigating doctor considers would make participation unsafe — including anyone considered unsuitable for a stem cell transplant.
• People with significant heart problems, including a heart attack in the six months before starting, unstable or poorly controlled heart conditions, uncontrolled irregular heart rhythms, an abnormal heart electrical reading above a specific threshold on screening tests, or uncontrolled high blood pressure.
• People whose blood test results at the time of enrolment fall outside acceptable ranges for white blood cell count, haemoglobin, platelet count, or liver function markers (confirm specific values with trial site).
• People with known allergies or serious reactions to monoclonal antibodies, human proteins, isatuximab, or related ingredients that cannot be managed with standard pre-medications.
• People with certain related but distinct blood or plasma cell conditions, including plasma cell leukaemia, Waldenström's macroglobulinaemia, POEMS syndrome, or light-chain amyloidosis.
• People who, in the investigating doctor's opinion, are unlikely to be able to follow the study requirements — for example due to substance dependence, a psychological condition, or any other circumstance that could affect their wellbeing or the reliability of the study results.
• People who are pregnant, breastfeeding, or planning to become pregnant from two weeks before the first study treatment until 16 weeks after the last dose.
• Men who are planning to father a child from two weeks before the first study treatment until 16 weeks after the last dose.
• 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 their expected time in the study or within two weeks after the last dose (minor procedures under local anaesthetic are generally not excluded — confirm with trial site).
• People with poorly controlled lung disease, defined as having been hospitalised for a lung condition such as asthma or chronic obstructive pulmonary disease within the six months before enrolment, or anyone with a previous history of lung inflammation (pneumonitis).

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