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 been diagnosed with multiple myeloma for the first time (before receiving any treatment), as confirmed by standard diagnostic guidelines.
• People who have received an initial treatment plan using a combination of at least two drug types from the following groups: immune-modifying drugs (IMiDs), proteasome inhibitors (PIs), and/or anti-CD38 antibody drugs.
• People who received initial (induction) treatment — with or without a stem cell transplant using their own cells — and have been on lenalidomide maintenance therapy for 12 months or less, AND who fall into one of two groups:
  • Group 1: People whose disease is currently showing a partial or complete response to treatment, but where a sensitive lab test (called the Adaptive ClonoSeq NGS assay) can still detect myeloma cells in their body.
  • Group 2: People whose disease had reached a complete response but has since shown early signs of returning — for example, small amounts of a myeloma protein have reappeared, or the ClonoSeq test has turned positive again — but where the disease has not yet progressed to the level that meets the standard definition of full relapse (confirm with trial site for exact criteria).
• People who are well enough to carry out basic daily activities, as measured by a standard health performance scale (ECOG score of 3 or lower, where 0 is fully active and 4 is completely disabled).
• People whose blood counts and organ function (including liver, kidneys, and blood cells) meet minimum levels required by the trial.
• People who test negative for pregnancy at the screening stage (applies to women who could become pregnant).
• People who are willing and able to use highly effective contraception throughout the study and for 90 days after the last dose of treatment (applies to women who could become pregnant, and to men who are sexually active with a woman who could become pregnant).
• People who are willing and able to give written informed consent before any screening procedures begin.
• People who are willing and able to attend clinic visits and follow all study-related procedures.

Who may not be able to join:

• People who have received any other systemic (whole-body) treatments for multiple myeloma beyond the standard initial combination therapy described above. Note: corticosteroids for myeloma or other conditions, prior radiation therapy, and prior surgery are permitted.
• People who are currently taking part in another clinical trial, unless the trial doctor determines there is no interference with this study.
• People who have received a live vaccine within 4 weeks before the scheduled start of study treatment.
• People who have a known contraindication (medical reason to avoid) any of the supporting medications used alongside the trial treatment, such as medications for infusion reactions, infections, blood clotting, or hydration.
• People living with HIV who also have any of the following: a history of AIDS-defining illnesses, a low immune cell count (CD4 below 350), a detectable viral load during or within 6 months before screening, not currently on effective HIV treatment, a recent change in HIV medication within 6 months of screening, or HIV medication that may interact with the study drugs.
• People with an active hepatitis B infection, or whose test results suggest active or unresolved hepatitis B virus in their blood. Some exceptions may apply for people with evidence of prior vaccination or resolved infection (confirm with trial site).
• People with an active hepatitis C infection detected by RNA testing. People who have a history of hepatitis C but completed antiviral treatment and had undetectable virus levels 12 weeks after finishing that treatment may still be eligible (confirm with trial site).
• People with a known allergy or serious reaction to drugs chemically or biologically similar to those used in this trial.
• Women who are currently breastfeeding and unwilling to stop during treatment or within 3 months after the last dose.
• People who plan to father a child during the study or within 3 months after the last dose of treatment.
• People with certain serious heart conditions, including severe heart failure (NYHA stage III or IV), a heart attack or heart bypass surgery within the past 3 months, a history of significant irregular heartbeat or unexplained fainting, or unstable heart-related disease.
• People with uncontrolled ongoing illness, including active serious infections, uncontrolled blood clots, active bleeding, lung scarring or inflammation, active autoimmune disease (with some exceptions such as vitiligo, type 1 diabetes, or a thyroid condition that is currently well-controlled), or significant mental health or social circumstances that would make it difficult to follow study requirements, within the past 2 weeks.
• People with a history of a neurodegenerative condition, a movement disorder affecting the brain or nervous system, or who have had a seizure within the past 12 months — unless the trial doctor determines the risk is not clinically significant.
• People who have had another active cancer (other than multiple myeloma) requiring treatment in the past 6 months. People whose other cancer was treated within the past 6 months and is considered cured with very low risk of returning may still be eligible (confirm with trial site).
• People with any other condition that, in the trial doctor's opinion, would affect their wellbeing or their ability to participate safely and fully.
• People who do not have the capacity to make their own informed decisions about participation.

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