Phase 1 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 have been diagnosed with active multiple myeloma and have a specific genetic marker called t(11;14), confirmed through a special bone marrow test run under an approved testing program — the bone marrow sample must be tested within 72 hours of collection
• People in Group 1 (previously treated): Those who have had at least one prior round of treatment for multiple myeloma, and that treatment did not include a drug called venetoclax
• People in Group 2 (newly diagnosed): Those who have had no more than one cycle of a standard myeloma treatment since their diagnosis
• People in Group 2 who are not being considered for a stem cell transplant
• Adults aged 18 or older
• People whose kidneys are functioning well enough, based on a blood test result taken within the past 14 days (confirm with trial site for specific threshold)
• People with blood test results within the past 14 days showing adequate levels of white blood cells, platelets, and red blood cells (confirm with trial site for specific thresholds)
• People with blood test results within the past 14 days showing the liver is functioning within acceptable ranges (confirm with trial site for specific thresholds)
• People whose myeloma is measurable, meaning at least one of the following is present: a certain level of abnormal protein in the blood, a certain amount of abnormal protein in a 24-hour urine sample, or abnormal levels of specific proteins in the blood called free light chains
• People who are reasonably physically active and able to carry out daily activities, rated on a standard scale (score of 0, 1, or 2 on the ECOG scale)
• People who are able to give written consent to participate
• People who are able to complete questionnaires, either on their own or with help
• Women who could become pregnant must have a negative pregnancy blood test done within 7 days before joining the trial
• Women who could become pregnant must be willing to follow strict birth control requirements, including using two forms of contraception starting 4 weeks before treatment, throughout treatment, and for 4 weeks after the last dose of lenalidomide — or commit to complete abstinence from heterosexual intercourse on a long-term and persistent basis
• Men must be willing to refrain from donating sperm and to use a condom (even after vasectomy) from the first dose of treatment until 28 days after the last dose of lenalidomide, and their female partners of childbearing potential must also use a highly effective contraceptive method — or men must commit to complete abstinence from heterosexual intercourse on a long-term and persistent basis
• People with a life expectancy of at least 12 weeks
• People willing to return to the enrolling site for follow-up visits during the active monitoring phase
• People willing to provide a bone marrow sample for research purposes
• People willing to follow the requirements of the Revlimid (lenalidomide) safety and risk management program (note: this may not apply to some patients in Group 2)

Who may not be able to join:

• People who have had another active cancer in the past 2 years, unless it was: a fully treated early-stage cervical condition, a fully treated skin cancer (basal cell or localised squamous cell), prostate cancer that requires no treatment, or a previous cancer that was fully removed or treated with the intent to cure
• People currently receiving other chemotherapy or other experimental treatments (note: bone-strengthening medications called bisphosphonates are allowed)
• People who have had major surgery within the past 14 days before joining the trial
• People with any medical condition, ongoing treatment, or abnormal test result that, in the treating doctor's opinion, could interfere with the trial results or with the person's ability to participate safely for the full duration
• People with a known history of HIV
• People who have taken certain medications that strongly or moderately affect how the body processes drugs (called CYP3A inhibitors or inducers) within the past 28 days (confirm with trial site for specific medications)
• People with a known allergy to any of the study medications or their ingredients
• People who have participated in another clinical trial within the past 30 days
• People with a known stomach or bowel condition, or who have had a bowel procedure, that could affect how the body absorbs venetoclax — including difficulty swallowing
• People with moderate to severe heart failure (rated above Class II on a standard heart failure scale)
• People with a current active hepatitis C infection confirmed by blood testing (people with a past hepatitis C infection that has fully resolved may still be eligible if a follow-up blood test confirms the infection is no longer active)

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