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:

• Adults aged 18 or older at the time of giving consent to participate.
• People who are not eligible to receive an autologous stem cell transplant (a procedure where a person's own stem cells are collected and returned after high-dose treatment).
• People who have tested negative for COVID-19.
• People who have a confirmed diagnosis of multiple myeloma (MM) according to standard international criteria.
• People whose MM still shows measurable signs of disease after their first round of treatment, based on specific protein levels in the blood or urine, as confirmed by laboratory tests.
• People whose planned next treatment is a second or later line of therapy using the combination of lenalidomide, dexamethasone, and a proteasome inhibitor (a type of cancer drug).
• People whose myeloma did not progress for more than 6 months after stopping a proteasome inhibitor, or who have never received one.
• People whose myeloma has progressed (worsened) during or after their most recent treatment, according to standard criteria.
• People who are reasonably able to carry out daily activities, as measured by a standard health performance scale (scores of 0–2 are eligible; a score of 3 may be considered if the only reason is bone pain from MM — confirm with trial site).
• People who are willing and able to follow the trial's strict pregnancy prevention plan, including using two forms of birth control at the same time (for women who could become pregnant) or using condoms (for men), and agreeing to regular pregnancy testing as required.
• People who are able to take blood clot prevention medication.
• People whose blood test results during the screening period meet specific minimum levels for white blood cells, platelets, haemoglobin, liver function, and kidney function (confirm exact values with trial site).
• People whose blood and kidney function results also meet specific minimum levels when checked again within 72 hours before starting the study treatment (confirm with trial site).
• People who are able and willing to receive treatment delivered through a small pump worn on the body at home (ambulatory therapy).
• People who have someone at home who is willing to be trained by a nurse to help manage the pump.

Who may not be able to join:

• People who are pregnant or breastfeeding.
• People who have already had an autologous stem cell transplant.
• People who have had a blood clot in a vein within the 12 months before starting the trial.
• People with active hepatitis B, hepatitis C, or HIV who are currently receiving treatment for those conditions.
• People currently taking any experimental (investigational) treatment for myeloma, unless at least 28 days have passed since that treatment ended.
• People who previously received lenalidomide as part of a treatment and did not respond to it.
• People who had to stop taking lenalidomide in a previous treatment because they could not tolerate it.
• People currently taking certain medications known to strongly interfere with the breakdown of the study drug in the body (confirm specific medications with trial site).
• People who have certain related blood or protein disorders at the same time as their myeloma, such as amyloidosis, plasma cell leukaemia, or POEMS syndrome.
• People who currently have an active infection that requires treatment with antibiotics or antiviral medications (preventive medications are acceptable).
• People who have had another cancer in the past 3 years, with some exceptions such as certain treated skin cancers, cervical or breast carcinoma in situ, or some low-risk prostate cancers under monitoring (confirm with trial site).
• People who have had major surgery or radiation therapy within 4 weeks before starting the study treatment (short radiation treatment for bone pain within 7 days is an exception).
• People who have any other condition that, in the treating doctor's judgement, would prevent them from safely participating or following the trial procedures.

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