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 19 years of age or older at the time of signing the consent form.
• People who are willing to sign a consent form before any study-related procedures take place, and who are able to follow the study schedule and requirements.
• People who have a confirmed diagnosis of multiple myeloma (MM) with measurable disease, shown through specific blood, urine, or light chain protein tests. (Note: People whose only measurable disease is outside the bone marrow as a plasmacytoma are not eligible.)
• People who have received 2 or more prior treatment courses for multiple myeloma.
• People who have previously been treated with at least one proteasome inhibitor and the drug lenalidomide.
• People whose myeloma responded at least minimally to at least one prior treatment.
• People whose myeloma has gotten worse during or after their most recent treatment.
• People whose general health and ability to carry out daily activities is rated at a score of 0, 1, or 2 on a standard medical scale (ECOG scale), meaning they are fully active, restricted in strenuous activity, or up and about more than half of waking hours (confirm with trial site).
• People who can become pregnant must have two negative pregnancy tests before starting treatment and must agree to ongoing pregnancy testing throughout the study. They must also agree to either avoid all heterosexual contact or use two forms of contraception — one highly effective method and one barrier method — starting 28 days before treatment, throughout treatment, and for at least 28 days after the last dose of mezigdomide or 150 days after the last dose of elranatamab, whichever is longer.
• Male participants must agree to use a condom during any sexual contact with a pregnant person or a person who could become pregnant, throughout the study and for at least 28 days after the last dose of mezigdomide, even after a vasectomy.
• Male participants must agree not to donate sperm during treatment and for at least 28 days after the last dose of mezigdomide.
• People who can become pregnant must agree not to donate eggs during treatment and for at least 28 days after the last dose of mezigdomide.
• All participants must agree not to donate blood during treatment and for at least 28 days after the last dose of mezigdomide.
• All participants must agree not to receive any live vaccines during treatment or for at least 90 days after the last dose of study treatment.

Who may not be able to join:

• People who have previously been treated with the study drug mezigdomide.
• People who have previously received any treatment targeting a protein called BCMA, including CAR T-cell therapy, bispecific antibodies, or BCMA-directed antibodies.
• People who have taken any other experimental treatment within 28 days (or within 5 half-lives of that drug, whichever is shorter) before starting this study.
• People who have had plasmapheresis (a procedure to filter the blood) within 28 days before starting treatment.
• People who have had major surgery within 28 days before starting treatment.
• People who have had radiation therapy (other than local pain-relief radiation for bone problems) within 14 days before starting treatment.
• People who have taken any systemic myeloma treatment within 14 days before starting treatment.
• People who have taken certain stomach acid-blocking medications (potassium competitive acid blockers such as tegoprazan or vonoprazan) within 7 days before starting treatment.
• People who have had a donor stem cell transplant within the past year, or their own stem cell transplant within 12 weeks before starting treatment. People who had a donor transplant must not have active graft-versus-host disease.
• People with plasma cell leukaemia, Waldenström's macroglobulinaemia, POEMS syndrome, or clinically significant light-chain amyloidosis.
• People whose myeloma has spread to the central nervous system (brain or spinal cord).
• People with significant medical conditions, active or uncontrolled infections, serious abnormal lab results, or psychiatric illness that would put them at unacceptable risk in the trial.
• People who have had COVID-19 within 7 days (mild or no symptoms) or 14 days (moderate or severe) before starting treatment, and whose symptoms have not fully resolved.
• People with any condition that would make it difficult to interpret study results.
• People with certain abnormal blood test results, including: low white blood cell counts, low platelet counts, low haemoglobin (anaemia), poor kidney function or being on dialysis, very high calcium levels, or elevated liver enzyme levels beyond set thresholds (confirm specific values with trial site).
• People with moderate or severe nerve damage in their hands or feet (peripheral neuropathy Grade 2 or higher).
• People with a digestive tract condition or prior stomach surgery (such as gastric bypass) that could affect how the body absorbs the study drugs.
• People who have had another cancer within the past 3 years, with some exceptions such as certain treated skin cancers or some pre-cancerous conditions treated with the intent to cure (confirm with trial site).
• People who have taken immune-suppressing medications within 14 days before starting treatment, with some exceptions for low-dose steroids or locally applied steroids (confirm with trial site).
• People who have taken certain medications that strongly affect how the body processes drugs (strong CYP3A modulators) or common proton pump inhibitor acid reflux medications (such as omeprazole or pantoprazole) within 2 weeks of starting treatment.
• People who have had significant heart problems within the past 6 months, including heart attack, unstable chest pain, serious irregular heartbeat, blood clots, stroke, a prolonged electrical interval on a heart tracing (QTcF greater than 470 msec), or reduced heart pumping function below 40%.
• People with uncontrolled high blood pressure or uncontrolled diabetes within 14 days before starting treatment.
• People who have received a live vaccine within 3 months before starting study treatment.
• People who are unable or unwilling to take required blood clot prevention or antiviral medications as part of the study.
• People who are HIV positive, or have active or chronic hepatitis B, active hepatitis A, or active hepatitis C (specific testing requirements apply — confirm with trial site).
• People who have had a severe allergic reaction to thalidomide, lenalidomide, pomalidomide, dexamethasone, or related drugs, or who have any other reason listed in the local product information that would prevent them from taking these medicines.
• People with severe ongoing nerve damage (Grade 3 or higher peripheral sensory or motor neuropathy), a history of Guillain-Barré syndrome, or a history of severe peripheral motor nerve disease.
• People who are currently pregnant, breastfeeding, or who plan to become pregnant during the study.

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