Phase 2 Myeloma Trial, Recruiting

Written by an AI model from the 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 confirmed as having symptomatic multiple myeloma (an active form of blood cancer affecting plasma cells) according to established international diagnostic standards.
• People whose myeloma was measurable at the time of diagnosis — meaning a certain level of abnormal protein was detectable in the blood, urine, or through a specific blood test at diagnosis.
• People who are over 18 years of age.
• People who have already had a stem cell transplant using a specific chemotherapy drug (Melphalan 140 mg/m²) within 12 months of starting initial myeloma treatment, and who are between 60 and 120 days after that transplant; or people who have not yet had a transplant but have started initial treatment within 12 months before the planned transplant date.
• People whose myeloma has not become resistant to a medication called lenalidomide.
• People whose myeloma has not progressed (gotten worse) at any point before joining the trial.
• People who are generally well enough to carry out light activity and care for themselves, based on a standard health scoring system (confirm with trial site).
• People whose blood test results meet specific minimum levels for red blood cells, platelets, white blood cells, liver function, kidney function, calcium, and bilirubin during the screening period and at the start of treatment (confirm with trial site for exact values).
• Women who could become pregnant must have a negative pregnancy test at screening and again within 48 hours before starting study treatment.
• Women who could become pregnant must either not be sexually active with men, have a partner who has had a vasectomy, or use at least two effective forms of contraception (at least one being highly effective) — and must continue this for 100 days after the last dose of study treatment. Women using hormonal contraception while receiving the study drug talquetamab must also use an additional barrier method.
• Women must agree not to donate or freeze eggs for reproductive purposes during the study and for 100 days after the last dose.
• Men must agree to use a condom with spermicide during any activity that could result in passing ejaculate to another person, throughout the study and for at least 100 days after the last dose; if their female partner can become pregnant, she must also use a highly effective form of contraception. Men who have had a vasectomy must still use a condom with spermicide, but their female partner does not need to use contraception.
• Men must agree not to donate sperm for reproduction during the study and for at least 100 days after the last dose.
• People who are willing and able to follow all lifestyle requirements outlined in the study, including not donating blood or blood products during the study and for 100 days after the last dose, and complying with the required safety programme (REMS) for lenalidomide, which includes regular pregnancy testing for women who can become pregnant.
• People who are willing to sign a consent form showing they understand the study and agree to take part.
• People who are willing to return to the study site for follow-up visits.

Who may not be able to join:

• People who cannot tolerate lenalidomide at a dose of 10 mg (or 5 mg for those with reduced kidney function).
• People whose myeloma has relapsed (come back) or become resistant to treatment at any time before joining.
• People who have a serious allergy, intolerance, or medical reason preventing them from taking any of the study drugs or their ingredients.
• People who have previously received certain types of treatments, including: any prior therapy targeting a specific protein called GPRC5D; prior T-cell redirection therapies or CAR-T cell therapies; gene-modified cell therapies within the last 3 months; certain experimental drug or device treatments within the last 21 days or within 5 half-lives of the drug (whichever is shorter); certain experimental vaccines (other than approved COVID-19 vaccines) within the last 4 weeks; live vaccines within the last 4 weeks; antibody treatments for myeloma within the last 21 days; chemotherapy within the last 21 days; proteasome inhibitor therapy within the last 14 days; immunomodulatory drug therapy within the last 14 days; or radiotherapy within the last 14 days (or targeted radiation within 7 days).
• People who have received a high cumulative dose of steroid medication (equivalent to 140 mg or more of prednisone) in the 14 days before the first dose of study treatment.
• People with known active spread of myeloma to the brain or spinal fluid, or signs suggesting this.
• People with plasma cell leukaemia, Waldenström's macroglobulinaemia, POEMS syndrome, or primary amyloid light chain amyloidosis (specific related blood disorders).
• People with a bone marrow condition called myelodysplastic syndrome, or any other active cancer that has been progressing or required a change in treatment in the last 24 months — with specific exceptions for certain fully treated and considered cured cancers, including some bladder, skin, cervical, prostate, and breast cancers, as well as other cancers considered cured with minimal risk of return (confirm with trial site for full details).
• People who have had a stroke, mini-stroke (TIA), or seizure within the 6 months before signing the consent form.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study or within 100 days after the last dose.
• Men who plan to father a child during the study or within 100 days after the last dose.
• People with significant heart problems, including: severe heart failure (New York Heart Association stage III or IV); a heart attack or heart bypass surgery within the last 6 months; uncontrolled irregular heart rhythm or significant abnormalities on a heart tracing (ECG); a history of serious irregular heart rhythms or unexplained fainting not due to dehydration or a simple cause; or a history of severe non-ischemic heart muscle disease.
• People known to have HIV, active hepatitis B infection, or active hepatitis C infection (people who have completed hepatitis C treatment and have had undetectable virus levels for at least 12 weeks may still be considered eligible — confirm with trial site).
• People who have had major surgery within 2 weeks before starting study treatment, have not fully recovered from surgery, or have major surgery planned during the treatment period or within 2 weeks after the last dose. Minor procedures under local anaesthetic, and certain spine procedures, are generally not considered major surgery (confirm with trial site if uncertain).
• People with other medical or mental health conditions that could interfere with the study or pose a risk, including: uncontrolled diabetes; certain serious lung conditions; active infections requiring treatment; active autoimmune disease requiring immune-suppressing medication within the last 6 months (with specific exceptions for vitiligo, controlled type 1 diabetes, and previously treated thyroid inflammation that is currently stable); serious psychiatric conditions, severe dementia, or significant changes in mental status; or any other condition that in the treating doctor's judgement would make participation unsafe or unsuitable.

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