Phase 2 Leukaemia 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 newly diagnosed with ultra high-risk multiple myeloma, defined as one of the following: (1) "double hit" myeloma, meaning the cancer has two or more high-risk genetic features, (2) myeloma that has spread outside the bone marrow, or (3) a form called primary plasma cell leukemia.
• People who have not yet received any treatment for multiple myeloma, or have only received bone-strengthening medication (bisphosphonates) or localised radiation therapy.
• People aged between 18 and 70 years.
• People considered fit enough for intensive chemotherapy and a stem cell transplant, as assessed by their treating doctor.
• People with a general health and activity level rated at 2 or below on a standard medical scale (meaning someone who is up and about and capable of self-care, even if not doing heavy physical activity) before starting treatment.

Who may not be able to join:

• People whose myeloma does not meet the definition of high-risk disease as described above.
• People whose primary diagnosis is Waldenström's disease, POEMS syndrome, or light chain amyloidosis (these are related but different blood conditions).
• People who have already received treatment specifically for multiple myeloma.
• People who have had, or currently have, another invasive cancer.
• People with a general health and activity level rated above 2 on the standard medical scale before starting treatment.
• People with a known significant allergy or intolerance to any of the drugs used in this trial, including daratumumab, carfilzomib, lenalidomide, dexamethasone, cisplatin, epirubicin, cyclophosphamide, melphalan, or etoposide.
• People who cannot safely take blood clot prevention medication.
• People with uncontrolled or serious heart or lung disease.
• People whose blood counts before treatment fall below certain thresholds — specifically, low platelet levels, low white blood cell counts, or low haemoglobin (confirm with trial site for exact values).
• People whose kidney function, liver enzyme levels, or bilirubin levels fall outside acceptable ranges before treatment — a liver condition called Gilbert syndrome may be considered separately (confirm with trial site).
• People known to be HIV positive, or who have active hepatitis B or hepatitis C infection.
• People whose heart pumping function or lung function test results fall below the levels required by the trial (confirm with trial site for exact values).
• People with uncontrolled diabetes, serious psychiatric illness, or other significant medical conditions that could interfere with completing the treatment.
• People with underlying health conditions that, in the treating doctor's opinion, would make taking the trial drugs unsafe.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial or within at least 6 months after the last dose of treatment.
• Men who plan to father a child during the trial or within at least 6 months after the last dose of treatment.
• People who have taken part in another clinical trial or used an experimental medical device within the 4 weeks before joining this trial, or who are currently enrolled in another interventional study.
• People who have had major surgery within 2 weeks before joining the trial, have not fully recovered from surgery, or have planned surgery during the trial period (note: certain minor spinal procedures are not considered major surgery — confirm with trial site).
• People who, for any reason, may not be able to follow the trial procedures as required.

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