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 have previously been diagnosed with multiple myeloma (a type of blood cancer) based on standard diagnostic guidelines.
• People who have been treated with at least 4 previous lines of myeloma treatment, including three specific types of therapy: an immunomodulating agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
• People who, in addition to those prior treatments, have received a specific cell therapy called ide-cel (in line with its approved prescribing guidelines in the US), responded to it at least partially, and are within 90 days of receiving that infusion.
• People who have signed a voluntary written consent form before any study-related procedures take place, with the understanding that consent can be withdrawn at any time.
• People who are physically well enough to carry out basic daily activities, as measured by a standard health performance scale (ECOG score of 2 or less, or Karnofsky score of 60% or more).
• People whose blood test results at screening fall within the following ranges: a white blood cell count of at least 1,000 cells/dL (without growth factor support in the 7 days prior); a platelet count of at least 75,000 cells/dL (without transfusion in the 7 days prior); a haemoglobin level of at least 8.0 g/dL (red blood cell transfusions are allowed); liver function values within acceptable limits; and kidney function showing a clearance rate of at least 30 ml/min based on a standard formula.
• People aged 18 or older.
• People who are able to understand and are willing to sign a written consent form.
• Women who could become pregnant must have two negative pregnancy tests before joining the trial, and must use specific contraceptive methods throughout the trial and for at least 28 days after the last dose of study medication.
• Sexually active men (including those who have had a vasectomy) must agree to use specific contraceptive methods during the trial and for at least 28 days after the last dose of study medication.
• All participants, regardless of sex or reproductive status, must agree not to donate blood products for at least 28 days after the last dose, and not to donate semen or sperm while taking the study medication or for at least 28 days after the last dose.

Who may not be able to join:

• People who have previously been treated with a drug called Iberdomide.
• People who are currently participating in another clinical trial or have done so within the 30 days before this trial starts.
• People who have been diagnosed with or treated for another cancer within the past 3 years, with some exceptions: completely removed skin cancers (basal cell or squamous cell), cancers that had not yet spread beyond their original location, or low-risk prostate cancer that has been successfully treated.
• People with known cancer involvement in the central nervous system (brain or spinal cord).
• People who have taken certain medications known to strongly affect how the body processes drugs (specific CYP3A inducers or CYP1A2 inhibitors, including some antibiotics, anti-seizure medicines, and others) within 14 days before the first dose, or who use St. John's wort herbal supplement.
• People whose medical or mental health situation, in the opinion of the trial doctor, would put them at excessive risk or make it difficult to participate safely or follow the study requirements.
• People who have active graft-versus-host disease (a complication from a donor stem cell transplant) at any stage.
• People who have had major surgery or radiation therapy within 14 days before starting treatment (though people who need a limited course of radiation for bone pain more than 14 days before starting treatment are not excluded).
• People with active or uncontrolled heart or blood vessel conditions, including uncontrolled high blood pressure, uncontrolled irregular heartbeat, symptomatic heart failure, unstable chest pain (angina), a significant blood clot event (grade 3 or higher), or a heart attack within the past 6 months.
• People who have received certain treatments too recently before starting the trial, including: chemotherapy for myeloma within 21 days (or 42 days for a specific type called nitrosoureas); live vaccines within 30 days; immunomodulating drugs or proteasome inhibitors within 14 days; other investigational treatments or monoclonal antibodies within 4 weeks; a peripheral stem cell transplant within 12 weeks; or an allogeneic (donor) stem cell transplant with active graft-versus-host disease.
• People who need more than 10 mg per day of a steroid medication (such as prednisone) on an ongoing daily basis, unless the dose has been stable for at least 7 days before starting treatment and is needed for a physiological reason (confirm with trial site); inhaled steroids are not affected by this rule.
• People with a condition called amyloidosis (protein build-up in organs) that is causing symptoms, or with plasma cell leukaemia (a related blood cancer).
• People with a condition called POEMS syndrome (a rare disorder involving blood cell abnormalities and effects on multiple body systems).
• People who have had a serious infection requiring antibiotic treatment within 7 days of starting therapy, unless they are only on preventive antibiotics or have confirmed that their active infection has fully resolved.
• People who test positive for active HIV, active hepatitis B, or active hepatitis C infections. People who test positive for certain hepatitis B markers must have a negative PCR test result before joining; those who test positive on the PCR test cannot join. People who test positive only because of a hepatitis B vaccine are not excluded.
• Women who are pregnant or breastfeeding.
• People who are currently receiving any other investigational (unapproved) treatment for any condition.
• People who have a history of a serious skin reaction (erythema multiforme) or severe allergic reaction to a previous immunomodulating drug, or who have a known allergy to any of the study medications or their ingredients.
• People who are unable to take blood clot prevention medication (thromboprophylaxis).
• People who have not sufficiently recovered from the side effects of previous chemotherapy (side effects must be at grade 2 or lower according to a standard medical grading scale).

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