Phase 3 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:

To register for the trial:

• People who have been newly diagnosed with symptomatic multiple myeloma, plasma cell leukaemia, or non-secretory multiple myeloma
• People whose treating doctor has decided that a stem cell transplant using their own cells is not appropriate as part of their first treatment
• People whose doctor has planned for them to receive a combination of three medicines: Daratumumab, Lenalidomide, and dexamethasone (DRd) as their first treatment
• People aged 18 years or older
• People who are able to give full informed consent to participate
• People who are willing to follow a pregnancy prevention plan during the study

To be assigned to a treatment group (randomisation) — all groups:

• People who have completed 6 cycles of DRd treatment after registering in this trial
• People who are able to give full informed consent
• People who are willing to follow a pregnancy prevention plan

Additional criteria depending on which treatment group a person may be assigned to (confirm with trial site):

• People who have had a partial response to treatment, or who have had a very good partial response or better but still have detectable disease at a very sensitive level (relevant to some groups)
• People who have had a very good partial response or better and have no detectable disease at a very sensitive level (relevant to one group)
• People classified as "fit" or "unfit" according to a standard frailty assessment tool (relevant to one group)
• People classified as "frail" according to a standard frailty assessment tool (relevant to one group)
• People who meet certain blood test requirements within 14 days before being assigned to a treatment group (relevant to one group; confirm with trial site)

Who may not be able to join:

At registration:

• People who have a less advanced or different form of the disease, including smouldering myeloma, primary amyloidosis, or a single tumour without wider evidence of myeloma
• People who are pregnant, breastfeeding, planning to become pregnant, or planning to father a child during the study or within 3 months after the last dose
• People who have previously received treatment for myeloma, except where the trial protocol specifically allows it (confirm with trial site)
• People who have an active serious infection requiring treatment with systemic medicines (specific rules about chronic infections are detailed in the trial protocol — confirm with trial site)
• People who are already taking part in another interventional clinical trial for myeloma that involves an investigational medicine

At the point of being assigned to a treatment group — all groups:

• People who have received any anti-myeloma treatment other than DRd before being assigned to a group (steroids taken for reasons unrelated to myeloma control are permitted)
• People who have had a stem cell transplant
• People who are already taking part in another interventional clinical trial for myeloma involving an investigational medicine
• People who are pregnant, breastfeeding, planning to become pregnant, or planning to father a child during the study or within a specified period after the last dose

Additional exclusion criteria depending on treatment group:

• People whose disease has remained stable or has gotten worse during treatment (relevant to some groups)
• People who have had only a partial response, stable disease, or worsening disease (relevant to one group)
• Certain safety-related criteria that apply to one specific group (confirm with trial site)

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