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 at the time of signing the consent form.
• People who have given written consent following guidelines set by federal, local, and institutional standards.
• People with multiple myeloma (MM) that can be measured through blood or urine tests, based on specific levels of certain proteins detected in lab results (confirm with trial site for exact thresholds).
• People joining certain treatment groups (Sd-40 BIW, Sd-100 BIW, or Sd-100 QW under earlier versions of the trial rules) whose MM has returned or stopped responding to treatment, and who have previously received at least 4 prior MM treatments — including at least 2 from each of two drug classes (proteasome inhibitors and immunomodulatory agents) and one anti-CD38 antibody treatment (confirm with trial site which version applies).
• People joining certain treatment groups (Sd-40 BIW or Sd-100 QW under later trial rules) whose MM has returned or stopped responding, and who have received at least 3 prior MM treatments — including exposure to at least 2 drugs from two specific classes and one anti-CD38 antibody — and whose MM stopped responding to at least one drug from each of those classes (confirm with trial site).
• People joining the SVd treatment group who have previously received between 1 and 5 prior MM treatments, and whose MM stopped responding to at least one drug from each of three specific treatment classes (confirm with trial site).
• People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale, meaning they are able to carry out daily activities with at most some limitations (confirm with trial site).
• Female participants of childbearing potential who agree to use two forms of contraception during the study and for 7 months after finishing treatment, and who have a negative pregnancy test at the start.
• Male participants who agree to use an effective barrier method of contraception if sexually active with someone of childbearing potential, throughout the study and for 4 months after finishing treatment.

Who may not be able to join:

• People with active plasma cell leukaemia.
• People with a confirmed diagnosis of systemic amyloid light chain amyloidosis (a condition where abnormal proteins build up in organs).
• People whose MM has spread to the central nervous system (brain and spinal cord).
• People joining the SVd group who have moderate to severe nerve damage (such as numbness, tingling, or pain in the hands or feet) at a certain level of severity, regardless of whether medication is being taken for it.
• People who have received radiation, chemotherapy, immunotherapy, or any other cancer treatment (including experimental treatments) within 2 weeks before the first dose (a limited short course of steroids may be permitted — confirm with trial site).
• People who have active graft-versus-host disease following a stem cell transplant from a donor at the time of starting treatment.
• People who still have significant ongoing side effects from previous cancer treatments at the time of starting the trial.
• People whose liver is not functioning well enough, based on specific blood test results being above certain levels (confirm with trial site for exact values).
• People whose kidneys are not functioning well enough, based on a kidney function calculation falling below a specific threshold (confirm with trial site).
• People whose blood cell counts are too low, including low levels of infection-fighting white blood cells, platelets, or red blood cells, based on specific lab measurements (confirm with trial site for exact values).
• People whose life expectancy is estimated by the treating doctor to be less than 4 months.
• People who have had major surgery within 4 weeks before starting treatment.
• People with an active, uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungal medicines within 1 week before the first dose.
• People with digestive or swallowing problems that would make it difficult to take tablets or absorb the study medication.
• People with a known active hepatitis A, B, or C infection, or who have tested positive for certain hepatitis markers.
• People who are pregnant or breastfeeding.
• People who cannot tolerate, are allergic to, or have a medical reason not to take steroid (glucocorticoid) therapy.
• People currently receiving any other approved or experimental cancer therapy, including topical (skin-applied) treatments.
• People who have previously been treated with a drug from the SINE compound class, including selinexor (the study drug).
• People with serious active psychiatric or medical conditions that, in the opinion of the investigating doctor or study sponsor, could interfere with participation.
• People who cannot take any of the other required medications or supportive treatments used alongside the study drug.

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