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:

• Adults aged 18 to 69 years old (inclusive).
• People who have given voluntary written consent to participate before any study-related procedures begin.
• People who have been newly diagnosed with multiple myeloma and whose doctors consider them suitable for high-dose chemotherapy (using a drug called melphalan) and a stem cell transplant using their own stem cells.
• People with confirmed active (symptomatic) multiple myeloma that can be measured through specific blood, urine, or bone marrow tests, and who show at least one sign of disease impact such as high calcium levels, reduced kidney function, low red blood cell levels, bone damage, or a high proportion of abnormal cells in the bone marrow.
• People whose general health and ability to carry out daily activities meets a minimum level, as rated by their doctor on a standard scale (ECOG score of 2 or below).
• People whose recent blood test results (within 15 days of starting treatment) meet specific minimum levels for red blood cells, infection-fighting cells, liver function, kidney function, calcium, and platelets — as assessed by the trial site.
• Women who could become pregnant must have a negative pregnancy test during the screening period and again within 3 days before starting treatment.
• People who are willing and able to attend all scheduled appointments, follow the treatment plan, and complete all required study procedures.

Who may not be able to join:

• People who have previously received any systemic treatment for multiple myeloma (though limited use of corticosteroids before screening may be acceptable — confirm with trial site).
• People who have received radiotherapy within 14 days before starting treatment.
• People who currently have moderate to severe nerve damage affecting sensation or movement (Grade 3 or higher peripheral neuropathy).
• People with a history of a serious nerve condition called Guillain-Barré Syndrome (GBS), or any history of severe peripheral motor nerve disease.
• People diagnosed with a related but different condition, such as primary amyloidosis, MGUS (monoclonal gammopathy of undetermined significance), smoldering myeloma, or a single isolated plasma cell tumour (solitary plasmacytoma).
• People with Waldenström's macroglobulinemia or similar conditions involving a specific type of abnormal protein (IgM) without the bone damage typical of multiple myeloma.
• People who have undergone plasmapheresis (a blood-filtering procedure) within 14 days before starting treatment.
• People with signs that multiple myeloma has spread to the fluid surrounding the brain and spinal cord.
• People with plasma cell leukaemia or a condition called POEMS syndrome.
• People with serious ongoing medical or psychiatric conditions — such as uncontrolled infections, uncontrolled diabetes, or certain lung conditions — that may interfere with the study or pose a risk to the person, as assessed by the treating doctor.
• People with significant heart problems, including a heart attack within the past year, unstable or uncontrolled heart conditions, uncontrolled irregular heart rhythms, or certain abnormal heart rhythm readings on an ECG.
• People currently taking certain specific medications that strongly affect how the body processes drugs (specific CYP1A2 and CYP3A inhibitors or inducers), or who have taken Ginkgo biloba or St. John's Wort within 14 days before starting treatment (confirm specific medications with trial site).
• People with known intolerance or allergies to any of the study medications or their ingredients that cannot be managed with standard pre-medications.
• People who have had major surgery within 2 weeks before joining the study, have not fully recovered from surgery, or have surgery planned during the study period (minor procedures such as kyphoplasty or vertebroplasty are not considered major surgery).
• People who have had another cancer (other than multiple myeloma) within the past 5 years, with some exceptions for certain early-stage or successfully treated cancers — confirm with trial site.
• Women who are pregnant or breastfeeding.
• Women who are able to become pregnant and are unwilling to abstain from heterosexual intercourse or use adequate contraception, starting at least 4 weeks before treatment begins and continuing for specified periods after each study drug is stopped.
• Men with partners who could become pregnant who are unwilling to use a condom during intercourse from the start of treatment until at least 4 weeks after stopping one of the study drugs, or who are unwilling to avoid donating sperm during this period.
• People who are known to be HIV positive, or who have active hepatitis A, B, or C infections that are uncontrolled — though some people with past hepatitis B or C exposure or those receiving antiviral treatment may still be eligible (confirm with trial site).
• People with an active serious infection currently requiring antibiotics given through a drip or injection.
• People with a stomach or bowel condition that may significantly affect how oral medications are absorbed.
• People who are unable or unwilling to take blood clot prevention medication as required by the study.
• People who are under legal guardianship, trusteeship, or who are detained by a legal or administrative order.

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