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 who are over 18 years old
• People who have been confirmed to have multiple myeloma (but not the slow-growing "smoldering" type, and not plasma cell leukemia), without significant organ damage from a related condition called amyloidosis
• People whose multiple myeloma was classified at any stage (1, 2, or 3) at the time of diagnosis — or, if the stage at diagnosis is not known, people whose doctors plan to use post-transplant maintenance therapy
• People who received no more than 2 rounds of treatment before their stem cell transplant, as long as their myeloma did not stop responding to certain specific drug types (see exclusions below)
• People who are either planning to have a stem cell transplant using high-dose melphalan chemotherapy, or who have already had one within the last 180 days and have not yet started maintenance therapy afterward
• People whose myeloma showed at least a partial response to treatment before the stem cell transplant
• People who were in reasonably good general health (able to carry out daily activities with little or no limitation) within the 30 days before enrolling
• People whose blood counts, kidney function, liver function, and blood clotting levels fall within the ranges required by the trial (confirmed by tests done within 30 days before enrolling)
• People for whom a confirmed supply of lenalidomide is already available through standard care at the time of joining the trial — note that the trial itself does not provide this medication
• People who are able to swallow oral capsules whole and who do not have significant digestive conditions that could affect how the study drug is absorbed (such as severe nausea, uncontrolled diarrhoea, malabsorption conditions, or previous bowel removal surgery)
• Women who could become pregnant and men must be willing to use two effective forms of contraception from the time of consent until 5 months after treatment ends (for women) or 1 month after treatment ends (for men), and to follow ongoing pregnancy testing and planning requirements during the study
• People who are willing to take a blood clot prevention medication (such as aspirin, low molecular weight heparin, a direct oral anticoagulant, or warfarin) while taking lenalidomide

Who may not be able to join:

• People whose myeloma stopped responding to, or got worse during or within 60 days of, treatment with anti-CD38 antibody therapy (such as daratumumab) or lenalidomide
• People who previously had a serious reaction or could not tolerate isatuximab or lenalidomide
• People who have previously had an allogeneic stem cell transplant (a transplant using cells from a donor)
• People who have had a solid organ transplant (such as a kidney or liver transplant) and are still taking immunosuppressive medication
• People with another active cancer that is growing or being treated — though some exceptions may apply, such as certain early-stage or fully treated cancers, or cancers for which the person has been cancer-free for at least three years (confirm with trial site)
• People whose myeloma has spread to the brain or spinal fluid at the time of enrollment
• People who have taken any experimental or investigational drug within the 30 days before enrolling
• People whose planned transplant is part of a back-to-back (tandem) transplant plan for newly diagnosed myeloma
• People with serious uncontrolled health conditions, including active infection, certain heart conditions, unstable heart rhythms, or significant mental health or social circumstances that could make it difficult to follow the study requirements
• Women who are pregnant, as the study drug carries a risk of serious harm to an unborn baby
• Women who are breastfeeding, as the study drug may pose a risk to nursing infants
• People with HIV may not be eligible unless their viral load is undetectable on active treatment and their immune cell count meets the required level (confirm with trial site)
• People with active or uncontrolled hepatitis B infection — those with certain past hepatitis B exposure may still be considered depending on their current test results (confirm with trial site)
• People with active hepatitis C infection may not be eligible, unless their viral load is undetectable with or without treatment (confirm with trial site)

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