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 are at least 18 years old.
• People who have given written consent to take part in the trial (or whose legal representative has done so).
• People who agree to allow stored tumour tissue samples from their diagnosis to be used for the study (exceptions may be possible with approval from the lead researcher).
• People who have a general health and activity level rated at 60% or above on a standard medical scale (meaning they are able to care for themselves and are up and about more than half of waking hours).
• People diagnosed with multiple myeloma that has spread to form soft-tissue tumours outside the bone marrow and not connected to any bone or bone lesion (called extramedullary disease, or EMD).
• People whose myeloma can be measured through blood, urine, or tumour tests that meet specific laboratory thresholds (confirm with trial site for exact values).
• People who have at least one of these soft-tissue tumour sites that the treating doctors feel needs palliative radiation — for example, due to pain, discomfort, or risk to a nearby vital structure.
• People whose target tumour site can be covered by a single radiation treatment field, as determined by the radiation oncologist.
• People who have previously been treated with three specific types of myeloma therapy: an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.
• People who have recovered from most side effects of previous cancer treatment before joining the trial.
• People who have completed prior cancer treatments within specific time windows before enrolling (timeframes vary by treatment type — confirm with trial site).
• People whose blood counts and organ function meet specific laboratory levels for white blood cells, platelets, haemoglobin, liver enzymes, bilirubin, and kidney function (confirm with trial site for exact values; repeat tests are permitted).
• Women who could become pregnant must have a negative pregnancy test before joining.
• People of childbearing potential who agree to use effective contraception or abstain from heterosexual activity during the study and for at least 6 months after the last dose of the study drug.

Who may not be able to join:

• People who have previously had radiation treatment to the specific tumour site being targeted in this trial.
• People who have previously received a therapy targeting a protein called GPRC5D.
• People who have previously received radiopharmaceutical therapy (radiation delivered through a drug or injection).
• People who have previously had radiation to more than 25% of their bone marrow.
• People who received an allogeneic (donor) stem cell transplant within the past 6 months, or an autologous (own cells) stem cell transplant within the past 12 weeks.
• People who have received high cumulative doses of corticosteroids (such as prednisone) — specifically 140 mg or more of prednisone or an equivalent — within the 14 days before the first study drug dose.
• People who had major surgery within 2 weeks before starting the study treatment, who have not fully recovered from surgery, or who have major surgery planned during the treatment period or within 2 weeks after the last study drug dose (minor procedures under local anaesthetic may be acceptable — confirm with trial site).
• People with an ongoing or active infection.
• People with severe persistent asthma or severe chronic obstructive pulmonary disease (COPD).
• People with certain serious heart conditions, including advanced heart failure, a recent heart attack or heart bypass surgery within 6 months, uncontrolled abnormal heart rhythms, a history of serious abnormal heart rhythms or unexplained loss of consciousness, or a history of severe non-ischemic heart muscle disease.
• People with a current hepatitis B infection, or an active hepatitis C infection (people who previously had hepatitis C but successfully completed antiviral treatment and have had no detectable virus for at least 12 weeks may be eligible — confirm with trial site).
• People with plasma cell leukaemia, Waldenström's macroglobulinaemia, POEMS syndrome, or primary amyloid light chain amyloidosis.
• People with known active myeloma involvement in the central nervous system (brain or spinal fluid), or signs suggesting this may be present.
• People with another active cancer whose treatment or progression could interfere with the safety or results of this trial.
• People who have had a stroke or seizure within 6 months before enrolling.
• People with a history of serious allergic reactions to drugs similar in composition to the study drug.
• People living with HIV who have a detectable viral load, a low CD4+ immune cell count, a recent AIDS-related infection, or recent changes to their HIV treatment due to the virus becoming resistant or due to toxicity (confirm with trial site for exact timeframes).
• People who are pregnant or breastfeeding.
• People with any other condition that the trial doctor believes would make participation unsafe.
• People who, in the trial doctor's opinion, may not be able to follow all of the study's procedures and requirements.

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