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 have been diagnosed with active multiple myeloma, as defined by international medical guidelines.
• People whose myeloma can be measured through a blood test showing a specific abnormal protein at a certain level, OR through a urine test showing abnormal protein levels, OR through a specific blood test measuring free light chains if the other tests do not show measurable disease.
• People who have been newly diagnosed with multiple myeloma and are being considered for high-dose chemotherapy.
• People aged 18 or older (and meeting the legal age of consent where the trial is taking place).
• People who are generally well enough to carry out normal daily activities with little or no restriction (this is measured using a standard medical scale called the ECOG score of 0 or 1).
• Male or female participants who meet the following reproductive health requirements:
  • Male participants must agree to use contraception during the trial and for at least 5 months after the last dose of treatment, and must not donate sperm during this time.
  • Female participants must not be pregnant or breastfeeding. Women who could potentially become pregnant must have a negative pregnancy test before starting treatment and must use a highly effective form of birth control, or remain abstinent, until at least 5 months after the last dose of treatment.
• People who have given their voluntary written consent to take part before any study procedures begin, with the understanding that they may withdraw their consent at any time without it affecting their medical care.
• For the second stage of the trial (after high-dose chemotherapy): people who meet all the above criteria and whose myeloma has responded to treatment (at least a partial response must be confirmed).

Who may not be able to join:

• People who have previously received, or are currently receiving, natural killer (NK) cell therapy or approved or investigational treatments for multiple myeloma.
• People who have taken an experimental drug within the past 14 days, or within 5 half-lives of that drug (whichever period is longer).
• People diagnosed with primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), or smoldering (asymptomatic) multiple myeloma.
• People diagnosed with Waldenström's disease or similar conditions involving a specific type of abnormal protein (IgM) without certain features of active myeloma.
• People who have previously received, or are currently receiving, systemic (whole-body) treatment or a stem cell transplant for symptomatic multiple myeloma — except for a short emergency course of steroid medication completed at least 14 days before joining the trial.
• People who currently have plasma cell leukaemia.
• People who have had a major medical procedure within 14 days before starting the study treatment, including plasmapheresis (a blood-filtering procedure), major surgery (note: a procedure called kyphoplasty is not considered major surgery for this purpose), or radiotherapy that is not being given for palliative (symptom-relief) purposes.
• People with an ECOG performance status score greater than 2 (meaning those whose health significantly limits daily activity).
• People with a haemoglobin (red blood cell) level below 8 g/dL (a measure of anaemia).
• People with a platelet count (cells that help blood clot) that is too low — the specific threshold depends on how much of the bone marrow is affected by myeloma (confirm exact levels with trial site). Platelet transfusions are not permitted within 3 days before the relevant blood test.
• People with a total bilirubin level (a liver marker) more than 1.5 times the upper limit of normal, unless they have a known condition called Gilbert syndrome.
• People with liver enzyme levels (AST and/or ALT) more than 3 times the upper limit of normal.
• People with a known allergy or serious sensitivity to any of the study medications or their ingredients, where this cannot be managed with standard preventative medications.
• People who, within the 6 months before joining the trial, have experienced any of the following heart or blood vessel conditions:
  • Second or third degree heart block (a type of irregular heart signal)
  • Poorly controlled high blood pressure
  • A heart attack
  • Severe or unstable chest pain (angina)
  • Heart or peripheral artery bypass surgery
  • Serious heart failure (New York Heart Association Class III or IV)
  • Significant heart rhythm problems (Grade 3 or higher)
  • A stroke or mini-stroke (transient ischaemic attack)
• People whose heart pumping function (left ventricular ejection fraction) is below 40%.
• People with a history of another cancer, with some exceptions: certain treated skin cancers, low-risk prostate cancer, early-stage bladder cancer, or any cancer for which chemotherapy was completed at least 3 years before enrolment and from which the person has been cancer-free for at least 3 years may still be eligible (confirm with trial site).
• People with HIV requiring antiviral treatment, or active hepatitis A, B, or C infection (as defined by specific blood test results — confirm details with trial site).

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