Phase 2 Myeloma Trial, Recruiting

Written by an AI model from the 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 able and willing to give written consent and follow the trial's schedule of visits, treatments, and tests
• People aged 18 years or older
• People diagnosed with smouldering myeloma (a pre-cancer blood condition) within the last 5 years, and specifically classified as intermediate or high risk within the last 2 years — this includes people whose risk level has recently changed from lower to higher
• People whose smouldering myeloma is classified as intermediate or high risk based on international guidelines, meaning at least 2 of the following are present: a high level of abnormal plasma cells in the bone marrow, a high level of abnormal protein in the blood, an abnormal ratio of certain protein fragments in the blood, or specific genetic changes detected in bone marrow testing
• People whose disease can be measured through at least one of several specific blood or urine protein tests (confirm with trial site for exact thresholds)
• People with a reasonable level of general physical functioning, rated 0 to 2 on a standard medical scale (meaning able to carry out daily activities, possibly with some limitations)
• People whose liver function tests are within an acceptable range
• People whose blood counts (white blood cells, red blood cells, and platelets) are at adequate levels
• People whose kidneys are functioning at an adequate level
• People who are willing to follow the contraception requirements set out by the trial

Who may not be able to join:

• People whose myeloma has progressed to active multiple myeloma that requires treatment
• People whose condition is diagnosed as a different related blood disorder, such as MGUS, solitary plasmacytoma, or AL amyloidosis
• People whose smouldering myeloma is classified as low or low-intermediate risk
• People who have previously received any treatment for myeloma, smouldering myeloma, or solitary plasmacytoma
• People who have received anti-cancer treatment (including experimental treatments) within the 4 weeks before joining the trial
• People whose abnormal proteins in the blood or urine have been rising very rapidly over a 2-month period (confirm with trial site for exact definitions)
• People who have been taking corticosteroid medications above a certain dose within 28 days before starting the trial
• People with certain serious heart conditions, including recent heart attack (within 4 months), severe heart failure, uncontrolled irregular heartbeat, or significant abnormalities on a heart tracing test — unless a pacemaker is in place
• People with a current or past diagnosis of another invasive cancer, with some exceptions: successfully treated skin cancers, low-grade prostate cancer not requiring active treatment, successfully treated early-stage breast or cervical cancer no longer needing intervention, or any cancer from which the person has been disease-free for at least 3 years
• People who have had major surgery within 21 days before joining, if the investigator believes this could affect the trial treatment or the person's ability to attend visits
• People with a known stomach or bowel condition that could affect how oral medications are absorbed, including difficulty swallowing
• People with an active infection affecting the whole body
• People with active or certain past hepatitis B virus (HBV) infection — some exceptions may apply for people with past infection if strict monitoring and antiviral treatment conditions are met (confirm with trial site)
• People who test positive for hepatitis C virus (HCV) — unless a further specific test confirms the virus is not active
• People who test positive for HIV — unless the condition is stable and well-managed on treatment, with satisfactory immune and viral levels
• People with any other medical or psychiatric condition that the trial investigator considers would make participation unsafe or unsuitable
• People who have received a live vaccine within 30 days before joining, or who would need one during the trial or within 3 months after finishing treatment
• People who cannot safely take blood-clot prevention medication
• People who have risk factors for seizures, or whose seizures are not well controlled with current medication
• People who are pregnant or breastfeeding

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