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 have given written consent to participate and agree to allow their personal health information to be used for the study, understanding they may withdraw at any time.
• People who are willing and able to follow the study visit schedule and other study requirements, in the judgment of the study doctor.
• People who are considered at high risk of serious side effects from standard intensive myeloma treatment — this is defined as scoring 2 or higher on a standard frailty scale (IMWG), having a Karnofsky Performance Status score of 70 or below, or being considered by their treating doctor as unsuitable for full-intensity treatment due to other health conditions or limitations (confirm with trial site).
• People who have been diagnosed with measurable multiple myeloma, confirmed by specific bone marrow and blood or urine test results showing abnormal protein levels and signs of organ involvement such as high calcium, kidney problems, anaemia, or bone damage.
• People who have had little or no prior treatment for myeloma — specifically, no systemic myeloma treatment lasting more than 28 days, and any prior treatment must have been completed at least 14 days before starting the study drugs.
• People who need localised radiation therapy may still be considered, provided the radiation is completed and at least 14 days have passed before starting the study treatment.
• People whose blood counts and kidney function meet the minimum levels required by the study, even if those levels were reached with the help of transfusions or growth factor support.
• Women of childbearing potential who test negative for pregnancy before starting treatment, and who commit to using two forms of birth control at the same time throughout treatment and for a set period afterward, as well as ongoing pregnancy testing during and after treatment.
• Men who agree to use a condom during sexual contact with a woman of childbearing potential throughout treatment and for a set period afterward, and who agree not to donate sperm during that time.
• All participants must be enrolled in and comply with the REVLIMID REMS program (a required safety programme for the study drug lenalidomide).

Who may not be able to join:

• People who have an active infection requiring antibiotics, or who have had a serious infection within 14 days before starting the study treatment.
• People whose treating doctor considers them unsuitable for any systemic treatment at all, due to extreme frailty, severe health conditions unrelated to myeloma, or other serious limitations unlikely to improve with myeloma therapy.
• People with significant uncontrolled medical conditions that, in the study doctor's opinion, could put them at excessive risk or affect study results.
• People with a diagnosis of light-chain (AL) amyloidosis, unless the amyloidosis is a secondary finding related to myeloma and is not causing any significant organ problems.
• People who have had a heart attack within the 3 months before study treatment, or who have severe heart failure (Class III or IV), uncontrolled chest pain, severe uncontrolled heart rhythm problems, or signs of acute heart stress on an ECG.
• People with a known allergy to any of the study medications or their ingredients.
• People with a known sensitivity or history of intolerance to specific ingredients in the study drugs that cannot be managed with standard pre-medications.
• People with a known digestive condition that could prevent them from properly absorbing or tolerating the oral study medications, including difficulty swallowing.
• People with a serious medical or psychiatric condition likely to make participation in the trial difficult.
• People currently taking other experimental treatments within 14 days or 5 half-lives of starting this study (whichever is longer).
• People currently receiving other cancer treatments, with limited exceptions as determined by the study team.
• People known to be HIV positive, or who have an active infection with hepatitis A, B, or C, or tuberculosis.
• People taking regular daily corticosteroids for conditions unrelated to myeloma at doses higher than a low daily threshold (for example, prednisone 10 mg daily or more).
• People taking other medications listed as prohibited in the study protocol that cannot be stopped or replaced with an alternative.

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