Phase 1 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 older than 18 years of age.
• People who have been diagnosed with multiple myeloma (confirmed by tissue testing) that has come back or gotten worse, based on standard international guidelines.
• People whose myeloma can be measured through specific blood or urine markers, or through a light chain blood test if the other markers are not detectable.
• People who have already received at least one course of treatment that included three specific types of therapy: a proteasome inhibitor, an anti-CD38 antibody, and an immunomodulatory drug (confirm with trial site for specific examples).
• People who meet the FDA's requirements for receiving the drug talquetamab, as set out in the most recent official prescribing information.
• People who are planning to receive cilta-cel and meet the FDA's requirements for its commercial use, as set out in the most recent official prescribing information.
• People who are generally able to carry out basic daily activities, rated 0 to 2 on a standard medical performance scale (meaning someone who is fully active to someone who is unable to do physically demanding work but can care for themselves).
• People whose blood test results at the start of the trial show that their bone marrow, liver, and kidneys are functioning at an acceptable level, as defined by specific measurements (confirm with trial site for exact values; some blood support before testing may be allowed).
• Female participants who are post-menopausal for at least one year, have had a surgical procedure that prevents pregnancy, or — if there is any chance of becoming pregnant — agree to use two reliable methods of contraception from the time of signing consent until three months after the last dose, and follow any pregnancy prevention program linked to the study treatments; true abstinence in line with one's usual lifestyle is also accepted (note: periodic methods such as calendar tracking or withdrawal are not accepted).
• Male participants, including those who have had a vasectomy, who agree to use effective barrier contraception throughout the study and for 90 days after the last dose, follow any relevant pregnancy prevention program linked to study treatments, or practice true abstinence in line with their usual lifestyle (note: periodic methods such as calendar tracking or withdrawal are not accepted).
• People who are able to understand and are willing to sign a written consent form.

Who may not be able to join:

• People who have previously received any form of CAR T-cell therapy or other adoptive T-cell therapy at any point.
• People who have previously received any bispecific antibody treatment, whether approved or investigational, at any point.
• People who have previously received talquetamab at any point.
• People who have previously received any therapy targeting BCMA or GPRC5D, including antibody-drug conjugates or monoclonal antibodies targeting these proteins.
• People who have previously received a donor (allogeneic) stem cell transplant at any point.
• People who received their own (autologous) stem cell transplant within the two months before enrolling.
• People who received high-dose chemotherapy within 28 days before enrolling.
• People who received certain chemotherapy drugs such as cyclophosphamide within 14 days before enrolling.
• People who received specific myeloma treatments — including a proteasome inhibitor, immunomodulatory drug, anti-CD38 antibody, or venetoclax — within 7 days before enrolling.
• People who received a total dose of dexamethasone of 100 mg or more within 14 days before enrolling.
• People who received radiation therapy within 7 days before enrolling.
• People who are currently experiencing serious (Grade 3 or higher) side effects from a previous treatment that are not related to blood counts.
• People whose myeloma has spread to the brain or spinal cord (central nervous system).
• People who have plasma cell leukaemia.
• People whose myeloma cannot be measured using standard markers (sometimes called non-secretory or oligosecretory myeloma).
• People who also have a condition called AL amyloidosis at the same time.
• People with serious heart conditions, including severe heart failure, a recent heart attack or related heart procedure within the past 6 months, weak heart pumping function, or severe non-ischemic heart muscle disease.
• People who need continuous supplemental oxygen at 2 litres per minute or more due to lung problems.
• People with serious neurological or psychiatric conditions, including confusion, dementia, or any condition that would prevent safe use of high-dose steroids or make it difficult to assess certain side effects.
• People with any medical condition that would prevent them from safely receiving the study drugs.
• People who have an active, uncontrolled bacterial, viral, or fungal infection.
• People who are HIV-positive and on combination antiretroviral therapy.
• People who are pregnant or breastfeeding, as the study drugs may cause harm to an unborn baby or infant.

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