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 were previously enrolled and treated in a specific trial called GMMG-HD8 / DSMM XIX, OR people who received a four-drug treatment for myeloma that included a proteasome inhibitor (such as bortezomib), an immunomodulatory drug (such as thalidomide or lenalidomide), dexamethasone, and an anti-CD38 antibody (such as daratumumab or isatuximab)
• People whose total induction and consolidation treatment added up to at least 4 and no more than 6 cycles, with no more than 2 cycles given after stem cell transplant
• People who have received at least one round of high-dose melphalan chemotherapy followed by an autologous stem cell transplant (where a person's own stem cells are used)
• People whose myeloma has responded to treatment at a level described as at least "Partial Response" based on international myeloma guidelines
• People aged 18 or older at the time of joining the trial
• People with a general health and activity level rated as 0, 1, or 2 on the WHO performance scale (meaning able to carry out at least some daily activities)
• Women who could become pregnant must have a negative pregnancy test at the time of joining
• All men and women who could become pregnant must be willing and able to use adequate contraception throughout the entire treatment period
• People who are able to understand what the trial involves and what it means for them personally
• People who have provided written consent to participate before enrolling

Who may not be able to join:

• People with a digestive or gut condition that could significantly affect how the study drug iberdomide is absorbed by the body
• People with a known allergy or serious sensitivity to any component of the study treatment that cannot be managed with standard pre-medications
• People who have had a serious allergic reaction to another immunomodulatory drug such as thalidomide, lenalidomide, or pomalidomide, including severe skin reactions or severe swelling
• People currently taking medications that are strong inhibitors or activators of a liver enzyme called CYP3A4/5 (confirm with trial site)
• People with certain other blood or plasma cell conditions, including systemic AL amyloidosis, plasma cell leukaemia, POEMS syndrome, or Waldenström macroglobulinemia
• People who have received any other systemic myeloma treatment beyond what is described in the inclusion criteria above
• People with severe heart failure classified as NYHA class III or IV
• People with significantly reduced liver function, unless this is due to myeloma itself or the stem cell transplant procedure
• People with active or uncontrolled hepatitis B or C, or detectable liver disease caused by these viruses (a history of hepatitis B or C may be acceptable under certain conditions — confirm with trial site)
• People who are HIV positive
• People with active infections that are not under control
• People with severe kidney problems (creatinine clearance below 30 ml/min) or who require dialysis
• People with nerve pain or nerve damage rated at grade 2 or higher
• People who have had another active cancer in the past 5 years, with some exceptions such as certain treated skin cancers or early-stage cancers (borderline cases must be reviewed by the study office before enrolment)
• People with serious widespread lung or heart lining (pericardial) disease
• People with certain immune-related blood conditions, including autoimmune haemolytic anaemia with a positive indirect Coombs test, or immune thrombocytopenia
• People with a platelet count below 75 x 10⁹/L
• People with a haemoglobin level of 8.0 g/dl or below, unless this is due to myeloma
• People with an absolute neutrophil count (a measure of infection-fighting white blood cells) below 1.0 x 10⁹/L (colony stimulating factor medications must not have been used within 14 days before this is tested)
• People with a corrected blood calcium level above 14 mg/dl (or above 3.5 mmol/l)
• People who are unable or unwilling to take blood clot prevention (thromboprophylaxis) treatment
• People who are pregnant or breastfeeding
• People with any other serious uncontrolled medical or psychiatric condition that could interfere with the trial or pose a risk to the person, in the opinion of the investigating doctor
• People who are in institutional care by order of a court or government authority
• People currently participating in another interventional clinical trial (note: being in a long-term follow-up period of a previous trial, with no active treatment, may be acceptable — confirm with trial site)

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