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 aged 18 or older who have given written consent to participate.
• People with a confirmed diagnosis of multiple myeloma that has come back or stopped responding to treatment, with measurable signs of the disease in blood or urine tests.
• People whose myeloma is causing symptoms, as determined by recognised international guidelines.
• People whose blood tests show measurable levels of myeloma-related proteins (specific thresholds apply depending on the type of myeloma — confirm with trial site).
• People whose side effects from previous treatments have mostly resolved before starting the trial.
• People who are well enough to carry out basic daily activities (assessed using a standard scale — confirm with trial site).
• People whose liver is functioning well enough, based on blood tests done within 28 days before starting treatment (the specific levels required depend on which treatment arm a person is enrolled in — confirm with trial site).
• People whose kidneys are functioning above a certain level, measured by a standard calculation (the minimum level required depends on which treatment arm applies — confirm with trial site).
• People whose blood counts (white cells, red cells, and platelets) are above certain levels within 28 days before starting treatment (exact levels vary by treatment arm — confirm with trial site).
• Women who could become pregnant must have a negative pregnancy test before starting, and both women who could become pregnant and men who could father a child must use highly effective contraception during and for 90 days after treatment.
• Depending on which treatment arm applies, people must also meet specific prior treatment history requirements — for example, having received a certain number of previous therapies, or not having previously received certain specific drugs. These vary by arm and should be confirmed with the trial site.

Who may not be able to join:

• People with smouldering (slow-developing, non-symptomatic) myeloma.
• People with a form of myeloma that does not produce measurable proteins in the blood or urine (non-secretory myeloma).
• People with an active condition called systemic amyloid light chain amyloidosis (a related but separate disease involving protein deposits in organs).
• People with active plasma cell leukaemia (a rare and aggressive blood cancer related to myeloma).
• People who have received blood transfusions or blood cell growth factor injections too recently before starting treatment (within 7–14 days, depending on the treatment arm).
• People who have had radiation, chemotherapy, immunotherapy, or other cancer-directed treatments within 2 weeks before starting (or radio-immunotherapy within 6 weeks), with some exceptions for certain steroids and targeted spot radiation.
• People who have had a major surgical procedure within 4 weeks before starting treatment.
• People with a history of spinal cord compression that has led to ongoing paralysis (applies to the dose escalation phase only).
• People who have taken part in another experimental cancer treatment within 3 weeks before starting.
• People who have had a stem cell transplant using their own cells less than 1 month ago, or a stem cell transplant using a donor's cells less than 3 months ago.
• People who have active graft-versus-host disease following a donor stem cell transplant.
• People with a life expectancy of less than 3 months.
• People with active, unstable heart problems, such as uncontrolled heart rhythm problems, heart failure of a certain severity, a heart attack within the past 3 months, or a reduced pumping function of the heart (specifics vary by treatment arm — confirm with trial site).
• People with uncontrolled high blood pressure (applies to most arms — confirm with trial site).
• People with an active, serious infection currently being treated with intravenous antibiotics, antiviral, or antifungal medications.
• People with a known active hepatitis A, B, or C infection.
• People with a known HIV infection.
• People with a digestive condition that prevents swallowing tablets or stops the body from absorbing medications properly.
• People who are currently pregnant or breastfeeding.
• People with a serious active psychiatric or medical condition that, in the doctor's opinion, would interfere with treatment.
• People with a known allergy or sensitivity to any of the medications used in the treatment arm they would be enrolled in.
• People in certain treatment arms (Arms 2, 4, and 8) who have significant nerve damage (neuropathy) of Grade 2 or higher, or nerve pain of Grade 2 or higher.
• People who have previously taken a type of drug called a selective inhibitor of nuclear export (SINE), including the drug selinexor.
• People in Arm 10 (SBd) who have an active corneal (eye surface) disease other than a mild form.
• People in Arm 12 (SMd) who have ever had a donor stem cell transplant or a solid organ transplant.
• People in Arm 12 (SMd) with a known severe allergic reaction to certain related drugs including thalidomide, lenalidomide, pomalidomide, carfilzomib, or dexamethasone.
• People in Arm 12 (SMd) who are unable or unwilling to follow the required blood clot prevention measures.
• People in Arm 12 (SMd) who are unable or unwilling to avoid donating blood during and after treatment.
• People in Arm 12 (SMd) who are taking certain medications that strongly affect how the liver processes drugs (strong CYP3A4 modulators) or certain stomach acid-reducing medications (proton pump inhibitors such as omeprazole) within 2 weeks before starting.
• People in Arm 12 (SMd) who are unable or unwilling to take required anti-nausea medications.
• People with another active cancer, or a history of another cancer within the past 3 years, with some exceptions for certain early-stage or treated skin cancers, cervical or breast carcinoma in situ, or organ-confined prostate cancer.
• People in Arm 12 (SMd) with a history of chronic hepatitis B with a detectable viral load.

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