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 18 years of age or older, of any gender.
• People who have previously been treated with at least three different myeloma drugs — specifically including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody — and whose myeloma has come back or stopped responding to the most recent treatment.
• People diagnosed with multiple myeloma (according to standard international guidelines) with measurable disease, shown by at least one of the following: a certain level of abnormal protein in the blood, a certain level of abnormal protein in the urine, or an abnormal level of free light chains in the blood (confirm with trial site for specific values).
• People who are generally well enough to carry out daily activities, as measured by a standard health scale scoring 0, 1, or 2 (confirm with trial site).
• People who are willing and able to follow the study schedule and all study requirements.
• Women who could become pregnant must have a negative blood pregnancy test before starting the trial, and both women who could become pregnant and men who are fertile must use a highly effective form of contraception from the start of the trial until 6 months after the last treatment dose.

Who may not be able to join:

• People who have a known allergy or sensitivity to any ingredient in the study drug.
• People who have been diagnosed with active plasma cell leukemia (a related but different blood cancer).
• People who have been diagnosed with systemic light chain amyloidosis (a condition where abnormal proteins build up in organs).
• People whose myeloma has spread to the brain or spinal fluid (central nervous system).
• People who have POEMS syndrome (a rare disorder related to abnormal plasma cells).
• People who have spinal cord compression caused by their myeloma.
• People who need to take other medications that strongly affect the way the body breaks down a particular liver enzyme pathway (CYP3A4) (confirm with trial site).
• People who have had plasma exchange therapy within 28 days before starting the study drug.
• People who have had certain recent anti-cancer treatments before starting the study drug, including: a monoclonal antibody, chemotherapy, or radiation therapy within the past 28 days; certain other targeted or experimental therapies within 28 days or 5 half-lives of the drug (whichever comes first); or proteasome inhibitors, certain traditional medicines, or high-dose steroid medications within the past 14 days (confirm with trial site for specific details).
• People who have received CAR-T cell therapy or a bone marrow transplant from a donor within the past 6 months, or who currently have active graft-versus-host disease (a complication where donated cells attack the body).
• People who have had their own stem cells transplanted (autologous transplant) within the past 12 weeks.
• People who have had major surgery or eye surgery within the past 28 days.
• People who have had another cancer diagnosed within the past 3 years.
• People who have a history of certain serious eye problems graded at level 3 or above, or other eye conditions graded at level 2 or above (confirm with trial site for specific definitions).
• People who have significant nerve damage, specifically nerve problems rated at grade 3 or higher, or grade 2 nerve problems that cause pain.
• People who still have side effects from previous cancer treatment that have not improved to a mild level (grade 1 or lower).
• People whose recent blood test results (within 7 days before starting) show: low red blood cell levels (hemoglobin below 80 g/L), low platelet count (below 50×10⁹/L), or low levels of infection-fighting white blood cells (neutrophils below 1.0×10⁹/L).
• People whose recent blood chemistry results (within 7 days before starting) show: poor kidney function (creatinine clearance below 30 mL/min) or elevated liver enzymes or bilirubin above certain thresholds (confirm with trial site).
• People with serious or uncontrolled heart or brain blood vessel conditions, including: significant heart failure, unstable chest pain not controlled by medication, a heart attack within the past 6 months, poorly controlled irregular heartbeat, an abnormal heart rhythm reading on an ECG (QTcF above 470 msec), reduced heart pumping function (ejection fraction below 40%), poorly controlled high blood pressure, or a stroke or mini-stroke within the past 6 months.
• People with certain lung conditions, including: chronic obstructive pulmonary disease (COPD) with significantly reduced lung function, moderate-to-severe or uncontrolled asthma, or certain types of lung inflammation (interstitial lung disease) requiring steroid treatment or suggested by current evidence.
• People who have an active bacterial, viral, or fungal infection, or who have needed intravenous antibiotics within 72 hours before starting the study drug.
• People with active or uncontrolled hepatitis B, hepatitis C, or HIV.
• People who are currently pregnant or breastfeeding.
• People who have a serious active mental health condition, medical illness, or other circumstances that the trial doctor believes could affect treatment, the ability to follow the study, or the ability to give informed consent.

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