Phase 1 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 diagnosed with multiple myeloma.
• People whose multiple myeloma has come back or stopped responding to three specific types of treatment: proteasome inhibitors, IMiDs, and anti-CD38 antibody therapy.
• People who have received at least 3 previous rounds (lines) of treatment for their multiple myeloma.
• People aged 18 or older.
• People who are well enough to carry out basic daily activities, as measured by a standard health performance scale (a score of 2 or lower on the ECOG scale, where 0 means fully active and 2 means up and about but unable to do heavy work).
• People who have more than 20% myeloma plasma cells found in a bone marrow sample taken within the last 30 days before joining.
• People whose blood counts meet minimum levels — specifically, white blood cell and platelet counts above certain thresholds — without needing recent blood transfusions.
• People whose liver and kidney function fall within acceptable ranges as determined by blood tests.
• People of childbearing potential (both men and women) who agree to use adequate contraception during the study and for 6 months after treatment ends.
• People who are able to understand the study and are willing to sign a written consent form.
• Before receiving the vaccine part of the trial, people whose serious side effects from a prior treatment (elranatamab) have reduced to mild or baseline levels.
• Before receiving the vaccine, people whose myeloma has not gotten worse after 2 cycles of elranatamab treatment.
• Before receiving the vaccine, people for whom the trial team has successfully produced at least 2 doses of the study vaccine.

Who may not be able to join:

• People who are currently taking part in another clinical trial involving an experimental treatment.
• People whose myeloma produces no detectable proteins in the blood or urine and no abnormal free light chains in the blood (a type called purely non-secretory myeloma). People with light chain myeloma detectable by a specific blood test are still potentially eligible (confirm with trial site).
• People who have a condition called Plasma Cell Leukemia.
• People who have HIV, or currently active hepatitis B or hepatitis C infection.
• People who have had a heart attack within the past 6 months, or who have severe heart failure, uncontrolled chest pain, serious heart rhythm problems, or signs of acute heart stress on a heart tracing (ECG).
• People with an active autoimmune or inflammatory condition that currently requires treatment.
• People with a history of another cancer, unless they have been cancer-free for at least 2 years and are considered low risk for it returning — or unless the other cancer was a non-invasive (in situ) cancer or a common skin cancer (basal cell or squamous cell) diagnosed and treated within the last 5 years.
• People who are pregnant or breastfeeding.
• People who have previously received an organ transplant and are taking medication to prevent rejection.
• People who previously received a type of immunotherapy called a PD-1 antibody and had to stop it due to serious side effects.
• People with uncontrolled or serious ongoing illness, including active infections, severe heart conditions, or mental health or personal circumstances that would make it difficult to follow the study requirements.
• People with a history of Guillain-Barré Syndrome (a nerve condition) or a history of severe nerve or muscle weakness affecting movement.

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