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 18 years of age or older (or the legal age of consent in their country) at the time of signing the consent form.
• People diagnosed with high-risk smoldering multiple myeloma (a pre-cancer blood condition), meeting at least one of two specific risk definitions based on protein levels in the blood, a type of immune cell ratio, or the proportion of abnormal cells in the bone marrow (confirm with trial site for which definition applies).
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard health performance scale (ECOG score of 0 or 1).
• People whose kidneys are functioning at a sufficient level, based on a blood or urine test done during the screening period.
• People with recent blood test results (within 21 days before screening) showing liver function values within acceptable ranges for bilirubin, AST, and ALT.
• People with a haemoglobin (red blood cell) level of at least 8.0 g/dL, without having received a blood transfusion in the 7 days before the test (the use of a medication to boost red blood cell production is allowed).
• People with a neutrophil count (a type of white blood cell) of at least 1.0 × 10⁹/L, without having received growth factor support in the 7 days before the test.
• People with a platelet count of at least 75 × 10⁹/L, without having received a platelet transfusion in the 7 days before the test.
• People with a lymphocyte count (another type of white blood cell) of at least 0.3 × 10⁹/L.
• People who test negative for HIV, or who are HIV positive but have the infection under control.
• Women who could become pregnant must have a negative pregnancy test at screening and within 72 hours before the first dose, and must agree to further pregnancy tests during the study.
• Women who could become pregnant must agree to use at least one highly effective form of contraception throughout the study and for 6 months after the last dose of study treatment; women using the oral contraceptive pill must also use an additional barrier method (such as a condom).
• Women who could become pregnant must agree not to donate or freeze eggs for the purpose of assisted reproduction during the study and for 6 months after receiving the study treatment (called cilta-cel), and should consider preserving eggs before starting treatment, as the treatment may affect fertility.
• Men must agree to use a condom during any activity that could result in passing ejaculate to another person, throughout the study and for 1 year after receiving cilta-cel; if their partner is a woman who could become pregnant, that partner must also use a highly effective form of contraception; men who have had a vasectomy must still use a condom, though their partner does not need to use additional contraception.
• Men must agree not to donate sperm for reproduction during the study and for 1 year after the last dose of study treatment, and should consider preserving sperm before starting treatment, as the treatment may affect fertility.
• Men must agree not to plan to father a child while in the study or within 1 year after the last dose of study treatment.
• People who are willing and able to sign a consent form showing they understand the study's purpose and procedures.
• People who are willing to provide additional biological samples as required by the study, confirmed by a separate consent form.
• People who are willing and able to follow the lifestyle requirements set out in the study guidelines.

Who may not be able to join:

• People with a history of certain uncontrolled conditions, including a different pre-cancer blood condition (MGUS), standard-risk smoldering myeloma, active multiple myeloma, light chain amyloidosis affecting organs, or disease that has spread outside the bone marrow.
• People who have been treated for non-muscle-invasive bladder cancer within the last 24 months, even if considered fully cured.
• People who have been treated for skin cancer (including or excluding melanoma) within the last 24 months, even if considered fully cured.
• People who have been treated for non-invasive cervical cancer within the last 24 months, even if considered fully cured.
• People with certain types of localised prostate cancer — including those with a low Gleason score treated recently or under monitoring, those with a Gleason score of 3+4 treated less than 6 months ago, or those currently receiving hormone-suppressing therapy for prostate cancer — depending on the specific circumstances (confirm with trial site).
• People who have been treated for certain early-stage, non-invasive breast conditions (lobular carcinoma in situ or ductal carcinoma in situ) and are considered fully treated.
• People with a history of localised breast cancer who are currently receiving anti-hormonal treatment and are considered to have a very low risk of the cancer returning.
• People who have a known allergy or intolerance to the study treatment (cilta-cel) or any of its ingredients.
• People who have had major surgery or a significant injury within 14 days before the first day of treatment.
• Women who are currently pregnant or breastfeeding.
• Men or women who could become pregnant and are unwilling to use adequate contraception.
• People with other serious health conditions that could interfere with participation, such as an uncontrolled infection or significant heart or lung disease.
• People with a mental or physical health condition that, in the treating doctor's opinion, could interfere with completing the treatment as planned.
• People with a history of a neurodegenerative condition (such as Parkinson's disease) or a stroke within the past 6 months.
• People who have received treatment for another cancer within 2 years before joining the trial, or who are currently receiving other chemotherapy or investigational treatments (note: bone-strengthening medications called bisphosphonates are allowed).
• People with an active or uncontrolled viral infection including HIV, hepatitis B (HBV), hepatitis C (HCV), or COVID-19 — with specific conditions applying to each (confirm with trial site for details, as some people with past or controlled infections may still be eligible depending on test results).
• People who, in the treating doctor's opinion, should not participate for any other reason related to their wellbeing or their ability to complete the required assessments.

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