Early Phase 1 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 or older at the time of registration.
• People who have had a full health history review and physical examination within the 28 days before registration.
• People with a general health status that allows them to carry out some daily activities (confirm with trial site for specific performance level required).
• People who have a confirmed diagnosis of active, symptomatic multiple myeloma with measurable levels of the disease in the blood, urine, or light chain tests at the time of diagnosis, and who required systemic treatment before a stem cell transplant. People with "smoldering" (slow-developing) myeloma are not eligible unless it has progressed to active myeloma.
• People who are willing and able to take blood clot prevention medication and follow the safety program requirements associated with the study drug lenalidomide.
• Women who could become pregnant must have negative pregnancy tests before starting the study drug, use two forms of birth control at the same time starting at least 28 days before the study drug begins, and agree to ongoing pregnancy testing and to not become pregnant for at least 3 months after the last dose of study treatment.
• Men must agree to use a latex condom during sexual contact with a woman who could become pregnant throughout the study and for 3 months after the last dose, even if they have had a vasectomy.
• People with kidney function at or above the minimum level required, as measured within 28 days before registration (confirm with trial site for specific values).
• People with adequate liver function, based on blood test results taken within 28 days before registration.
• People who meet the transplant suitability requirements of the treating institution.
• People living with HIV, provided they are on effective treatment and have an undetectable viral load at their most recent test within the 6 months before registration.
• People who are able to swallow oral capsules whole.
• People who have been informed about the study and have signed a written consent form.

Who may not be able to join:

• People who have organ involvement or organ damage related to a condition called amyloidosis.
• People whose myeloma has progressed (worsened) at any point before registration.
• People who have not been able to tolerate the starting dose of the study drug lenalidomide (10 mg).
• People who have previously had a donor (allogeneic) stem cell transplant, an organ transplant requiring ongoing immune-suppressing medication, or who have already had a previous autologous (own cells) stem cell transplant.
• People with a history of another cancer, with some exceptions: adequately treated certain skin cancers, early-stage cervical cancer, a Stage I or II cancer that is currently in full remission, or any cancer from which the person has been cancer-free for three or more years.
• People who have received any experimental treatments within 14 days before registration.
• People who test positive for Hepatitis B.
• People who test positive for Hepatitis C.
• People with high calcium levels in the blood at the time of study entry.
• People whose myeloma did not respond to lenalidomide (refractory disease).
• People with significant stomach or bowel conditions that could affect how the study drug is absorbed, such as uncontrolled nausea, vomiting, diarrhoea, or certain bowel diseases or surgeries.
• People with known allergies to any of the study drugs.

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