Phase 3 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 multiple myeloma that has come back (relapsed), with signs of the disease that can be measured, and who have previously been treated with a stem cell transplant using their own cells (ASCT).
• People whose myeloma first came back at least 12 months after their first stem cell transplant, and who now need treatment.
• People who are reasonably well and able to carry out daily activities, as assessed by a standard medical scale called the ECOG Performance Status (scores 0, 1, or 2).
• People aged 18 years or older.
• People whose recent blood tests (taken within the last 14 days) show enough white blood cells and platelets to meet the trial's requirements — platelet transfusions within 3 days before joining are not allowed to meet these levels.
• People whose kidneys are working well enough, based on a blood test taken within the last 14 days (confirm with trial site for exact levels required).
• People whose liver is working well enough, based on blood tests taken within the last 14 days (confirm with trial site for exact levels required).
• People whose lungs are working well enough, based on a breathing test taken within the last 14 days, with no significant history of lung disease (or, if there is a history, clearance from a lung specialist is required).
• People whose heart is working well enough, based on a heart scan taken within the last 12 weeks showing the heart is pumping adequately (confirm with trial site for exact level required).
• Female participants who are either not able to become pregnant, or who agree to use two effective methods of contraception at the same time from signing the consent form until 90 days after the last dose of the study drug — or who agree to complete abstinence in line with their usual lifestyle. Contraception must follow the requirements of the Celgene Thalidomide Pregnancy Prevention Programme.
• Male participants, including those who have had a vasectomy, who agree to use effective barrier contraception throughout treatment and for 90 days after the last dose — or who agree to complete abstinence in line with their usual lifestyle. Contraception must follow the requirements of the Celgene Thalidomide Pregnancy Prevention Programme.
• Female participants who are able to become pregnant must have a negative pregnancy test carried out by a healthcare professional before joining, in line with the Celgene Thalidomide Pregnancy Prevention Programme.
• People who agree not to take part in any other clinical trial or receive any other experimental treatment from 30 days before joining this trial until their disease progresses.
• People who are able to give written consent to take part.

Who may not be able to join:

• People who have already received a second round of treatment for their relapsed myeloma, beyond what is specifically allowed (limited exceptions include certain radiotherapy, therapeutic plasma exchange, or a capped dose of dexamethasone not taken within the past 30 days — confirm with trial site).
• People who have moderate or severe nerve damage (such as numbness, tingling, or pain in hands or feet) in the 14 days before joining.
• People who are known to be HIV positive.
• People who are known to be resistant to, unable to tolerate, or allergic to any part of the planned trial treatments.
• People who have a medical or psychiatric condition that the trial doctor believes would make participation unsafe or unsuitable.
• People who have had, or currently have, another type of cancer — with the exception of certain completely removed skin cancers or early-stage cancers that have not spread (such as certain cervical cancers).
• Female participants who are pregnant, breastfeeding, or currently lactating.
• People who have not yet recovered from the side effects of previous chemotherapy (side effects must be at a mild level or gone completely before joining).
• People who have had major surgery within 14 days before joining.
• People whose myeloma has spread to the central nervous system (brain or spinal cord).
• People who have an ongoing or serious infection requiring antibiotic treatment, or who have had a serious infection within the 14 days before joining.
• People with uncontrolled heart conditions, including uncontrolled high blood pressure, uncontrolled irregular heartbeat, heart failure with symptoms, unstable chest pain, or a heart attack in the past 6 months.
• People who have taken certain strong medications (confirm with trial site for specific drug names) or supplements such as Ginkgo biloba or St. John's Wort within 14 days before starting the trial drug ixazomib.
• People who have a known stomach or bowel condition, or who have had a bowel procedure, that could affect how the trial drug ixazomib is absorbed — including difficulty swallowing tablets.
• People who have previously been treated with the trial drug ixazomib, or who have taken part in any previous study involving ixazomib.
• People who have a current or past hepatitis B or hepatitis C infection.

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