Phase 4 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 newly diagnosed with multiple myeloma (those who have received up to one cycle of a bortezomib-based treatment for urgent reasons such as bone pain, kidney problems, or high calcium levels may still be considered)
• People aged 18 or older
• People whose disease can be measured through specific blood, urine, or imaging tests showing levels of abnormal proteins or detectable tumors above certain thresholds
• People with a physical functioning score showing they are reasonably mobile and able to care for themselves (ECOG score of 2 or less)
• People whose myeloma has specific high-risk genetic changes recognised in standard cancer guidelines, such as t(4;14), t(14;16), t(14;20), Del(17p), TP53 mutation, Del(1p32), or extra copies of chromosome 1q21, including cases where two or three of these are present at the same time
• People whose myeloma is classified as R-ISS stage 3 (an advanced stage based on standard scoring)
• People who also have plasma cell leukaemia, defined as having 5% or more clonal plasma cells circulating in the blood
• People whose bone marrow is producing enough normal blood cells (neutrophils and platelets above specified levels)
• People whose liver function tests are within an acceptable range (no more than 3 times the upper normal limit for certain liver enzymes, and bilirubin no more than 2 times the upper normal limit)
• People whose kidneys are filtering at a rate of at least 40 mL per minute
• Women of childbearing potential who have a negative pregnancy test, and all participants who agree to use effective contraception during treatment and for one year afterward
• People who are willing and able to sign informed consent (or have a legal representative do so if they are unable)

Who may not be able to join:

• People who have a pre-cancerous or early form of the condition rather than active multiple myeloma, such as MGUS, smouldering myeloma, or primary light chain amyloidosis affecting organs
• People who were diagnosed with or treated for another cancer within the past year, or who still have signs of a previously diagnosed cancer
• People with serious other health conditions that could interfere with participation, such as uncontrolled infections, significant heart or lung disease, or who are already receiving other experimental treatments
• People who have nerve damage (peripheral neuropathy) causing pain, rated at grade 1–2 or above, within the 30 days before joining the trial
• People who have had major surgery within 14 days before joining the trial
• People with uncontrolled heart or blood pressure problems, including uncontrolled high blood pressure, certain abnormal heart rhythms, heart failure (New York Heart Association class III or IV), unstable chest pain, or recent heart attack
• People with known moderate-to-severe chronic obstructive pulmonary disease (COPD) with lung function below 50% of expected, active or recent asthma (within the past 2 years), unless the asthma is mild and well-controlled
• People whose kidneys are filtering at less than 40 mL per minute (moderate or severe kidney insufficiency)
• People known to be HIV positive
• People with active hepatitis B infection, or those with certain hepatitis B blood markers and a detectable hepatitis B virus level on a specific DNA test (confirm with trial site for details on exceptions related to prior vaccination)
• People with known or suspected active hepatitis C infection
• People with a medical or mental health condition that, in the investigator's view, may prevent them from completing the treatment
• People with a known allergy or intolerance to the trial drugs
• People who are unable to follow the trial procedures and requirements
• People who are pregnant, breastfeeding, or of childbearing potential who are not willing to use adequate contraception, due to unknown risks of the study drugs to an unborn child or newborn

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