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 older than 18 years of age
• People who have been diagnosed with smoldering multiple myeloma (a pre-active stage of a blood cell condition) for 5 years or less, with detectable levels of an abnormal protein in their blood or urine
• People whose bone marrow contains between 10% and less than 60% abnormal plasma cells (a type of blood cell)
• People who have at least 2 of the following high-risk features: a high level of abnormal protein in the blood (≥2 g/dL), more than 20% abnormal plasma cells in the bone marrow, or a significantly abnormal ratio of certain proteins in the blood (confirm with trial site)
• People who are fully active or have only minor restrictions on physical activity (as measured by a standard medical scoring system called ECOG, scores 0 or 1)
• People whose recent blood test results fall within acceptable ranges for immune cell counts, platelet counts, and liver function — tests must have been done within 15 days before starting the trial
• People who are willing and able to sign a consent form agreeing to take part in the study
• Women who could become pregnant must have a negative pregnancy test before starting the trial and must agree to use two reliable forms of contraception at the same time throughout the trial and for at least 5 months after the last dose of the study drug, and must agree to report any pregnancy during the study

Who may not be able to join:

• People who have previously received any systemic (whole-body) treatment for multiple myeloma
• People whose smoldering multiple myeloma has already caused serious complications, such as high calcium levels in the blood, kidney problems, significant anemia (low red blood cell levels), bone damage or lesions, 60% or more abnormal plasma cells in the bone marrow, very abnormal protein ratios in the blood, or more than one bone lesion of 5mm or larger detected on a full-body scan
• People who have been diagnosed with a related but different condition, such as primary amyloidosis, POEMS syndrome, monoclonal gammopathy of undetermined significance, active (symptomatic) multiple myeloma, or a solitary plasmacytoma
• People who have a condition called Waldenström's macroglobulinemia or other similar conditions involving a specific type of abnormal protein (IgM) without the typical bone involvement
• People who have had a plasma exchange procedure (plasmapheresis) within the 14 days before eligibility is confirmed
• People who have had a heart attack within the 6 months before enrolling, or who have serious heart conditions such as severe heart failure, uncontrolled chest pain, dangerous irregular heart rhythms, or signs of acute heart stress on an ECG
• People who currently have moderate or severe nerve damage causing sensory or movement problems, a history of a serious nerve condition called Guillain-Barré syndrome, or a history of severe nerve damage affecting movement
• People who have had major surgery within 2 weeks before eligibility is confirmed, have not fully recovered from surgery, or have surgery planned during the expected period of participation
• People who have a currently active, clinically significant infection or serious ongoing medical conditions
• People with a history of another cancer, unless it was a skin cancer or an early-stage cancer (cervical, breast, or prostate) that was fully treated and has been free of disease for at least 5 years
• Women who are currently pregnant or breastfeeding
• People with a serious medical or psychiatric illness that is likely to interfere with taking part in the study
• People with uncontrolled diabetes
• People with a known HIV infection, active hepatitis B or C, or an active COVID-19 infection
• People who have received a live vaccine within 4 weeks before the first dose of the study drug
• People who are currently taking corticosteroids (such as prednisone) at a dose greater than 10mg (confirm with trial site)
• People who are under legal guardianship, trusteeship, or whose freedom has been restricted by a legal or administrative order

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