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:

• You are willing to sign a consent form agreeing to take part in the study.
• You are aged 18 or older but under 70 years old.
• You have been newly diagnosed with multiple myeloma, and your disease can be measured through specific blood, urine, or protein tests that meet certain levels.
• Your myeloma has at least two specific high-risk genetic changes identified through testing (confirm with trial site for exact types).
• Your general health and ability to carry out daily activities meets a certain minimum level on a standard scale, or your limited mobility is due to myeloma affecting your bones.
• You have not previously received chemotherapy, major radiation to the pelvis, or steroid medicines for myeloma — except short-term steroids (14 days or less) used to manage symptoms.
• Your liver is working well enough, based on blood test results that fall within acceptable ranges.
• Your kidneys are working at a minimum level, based on a standard calculation of kidney function.
• Your blood counts (white blood cells, infection-fighting cells, red blood cells, and platelets) meet minimum levels on a recent blood test.
• If you have recently received growth factor injections to boost blood cells, at least 2 weeks have passed before your screening tests.
• If you have recently had a blood or platelet transfusion, enough time has passed (at least 1–2 weeks) before your blood levels are assessed.
• You are able to take blood-thinning (anticoagulant) medication as recommended by the study.
• If you are a woman who could become pregnant, you agree to use effective contraception from signing the consent form until 3 months after your last dose, and you have a negative pregnancy test during screening.

Who may not be able to join:

• You have a type of blood cancer called primary plasma cell leukemia.
• You have a condition called secondary amyloidosis (a build-up of abnormal proteins in organs).
• Your myeloma has spread to your brain or spinal cord (central nervous system).
• You are planning to receive a bone marrow transplant from a donor (allogeneic transplant).
• You have moderate to severe nerve damage (numbness, tingling, or pain in hands/feet) above a certain severity level.
• You have a known allergy, intolerance, or medical reason preventing you from taking steroids, bortezomib, lenalidomide, or daratumumab (medicines used in this trial).
• You have significant heart problems, such as a recent heart attack, uncontrolled heart failure, severe heart rhythm problems, or an abnormal heart electrical reading above a certain level.
• You have diabetes or high blood pressure that is not well controlled.
• You have been diagnosed with another cancer within the last 5 years.
• You have an active HIV infection or test positive for HIV.
• You have active hepatitis B or C infection, or certain positive test results that cannot be confirmed as inactive before joining.
• You are currently pregnant or breastfeeding.
• Your life expectancy is less than 6 months.
• You have a digestive condition that prevents you from properly swallowing or absorbing tablets.
• You have had major surgery within 2 weeks before screening, have not fully recovered from surgery, or have surgery planned during the study (minor procedures under local anaesthetic may be acceptable — confirm with trial site).
• You have received a live vaccine (such as certain flu or travel vaccines) within 4 weeks before your first dose of the study drug.
• You have a serious mental health or physical condition that, in the doctor's opinion, could affect your treatment or ability to participate safely.
• You have any other condition, complication, or circumstance that could interfere with the study or your safety (confirm with trial site).
• You are unwilling or unable to follow the study rules and schedule.

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