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 intermediate- or high-risk smoldering multiple myeloma (a pre-cancer blood condition that has not yet caused organ damage) within the last 5 years, confirmed by specific lab or bone marrow test results.
• People of any race, ethnic background, or gender are eligible.
• People who are generally well enough to carry out light activity or self-care, as measured by a standard health performance scale (confirm with trial site).
• People whose blood counts meet minimum levels — including white blood cells, red blood cells, and platelets — without needing recent transfusions or certain blood-boosting medications in the 8 weeks before screening.
• People whose kidneys are functioning at or above a minimum level, as measured by a standard calculation (confirm with trial site).
• People whose liver function test results fall within acceptable ranges.
• People whose heart pumps blood effectively enough to meet a minimum function threshold, as measured by a heart scan.
• Women who could become pregnant must have two negative pregnancy tests before starting treatment, and must agree to ongoing pregnancy testing throughout the study and after it ends.
• Women who could become pregnant must commit to either complete abstinence from heterosexual contact or use two forms of contraception — one highly effective and one barrier method — starting 28 days before treatment, throughout the study, and for at least 28 days after the last dose.
• Male participants must agree to use an adequate method of contraception during the study and for 3 months after it ends.
• All participants must agree not to donate blood, sperm, or eggs while on treatment and for at least 4 weeks after stopping.
• People who have had or currently have another cancer, where that cancer and its treatment are unlikely to interfere with this study's safety or results.
• People who are willing and able to attend all required study visits and follow the study's requirements, and who have read and signed a consent form before any study procedures begin.

Who may not be able to join:

• People whose smoldering multiple myeloma has progressed to active multiple myeloma that requires treatment, based on specific medical criteria.
• People with certain related blood or plasma cell conditions, including MGUS, POEMS syndrome, plasma cell leukemia, AL amyloidosis, or Waldenström's macroglobulinemia.
• People who are currently receiving intravenous bisphosphonate medication (a bone-strengthening drug) more than once a year.
• People who have previously received or are currently receiving any treatment for a plasma cell disorder.
• People with active hepatitis B or C infection.
• People living with HIV who have a low immune cell count (below 350), have a history of AIDS-related illness, or are currently prescribed certain specific HIV medications (zidovudine or stavudine).
• People with serious uncontrolled health conditions, including active infections, severe heart failure, unstable chest pain, irregular heart rhythms, a heart attack in the past 6 months, or mental health or social situations that could make it difficult to follow the study requirements.
• People with digestive or gut conditions that could significantly affect how the study medication is absorbed by the body.
• Women who are pregnant or breastfeeding, as the study medication may harm an unborn baby or nursing infant.
• People who have used immune-suppressing medications within 14 days before the first dose of study treatment (certain low-dose or locally applied steroids may be exceptions — confirm with trial site).

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