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:

• Adults aged 18 or older (male or female)
• People who have a specific gene mutation (called a RAS/KRAS/NRAS mutation at codon 12 or 13) found in bone marrow testing using a particular panel called VariantPlex Myeloid Panel
• People who have been diagnosed with high-risk smoldering multiple myeloma (an early, not-yet-active stage of myeloma) meeting specific international diagnostic guidelines, with certain abnormal blood or bone marrow results measured at screening (confirm with trial site for exact thresholds)
• People who have been diagnosed with active multiple myeloma, still have measurable signs of the disease, and have already received at least one round of treatment
• People whose disease can still be measured according to international myeloma guidelines at the time of joining
• People with multiple myeloma who were suitable for a stem cell transplant must have already had that transplant, and at least 3 months must have passed since the transplant before joining
• People who are not expected to need a new or urgent treatment for their myeloma for at least 2 months
• People whose myeloma markers (signs of the disease in blood or bone marrow) have not been decreasing over the last two treatment cycles or two months
• People who had a stem cell transplant and whose myeloma markers were reducing during the last two cycles before transplant must have already tried a standard maintenance medication called lenalidomide for at least two cycles after the transplant (lenalidomide would be stopped upon entering the study)
• People who are in good general health, able to carry out everyday activities with little to no limitation (measured by a standard health scale called ECOG 0–1)
• Women who could become pregnant must have a negative pregnancy test at the start of the study and agree to use a highly effective form of contraception during treatment and for 3 months after the last dose
• Men who are sexually active with a woman who could become pregnant must use an effective barrier form of contraception during treatment and for 3 months after the last dose
• People who are able to give written consent and are willing and able to follow the study requirements

Who may not be able to join:

• Women who are pregnant, breastfeeding, or who have not had a pregnancy test at the start of the study (women who have not had a period for at least 12 months are considered past childbearing age)
• People with certain serious medical conditions, including any uncontrolled infection, severe uncontrolled heart failure (class III or IV), uncontrolled inflammation affecting the body or digestive system, or a history of bad reactions to vaccines
• People who have another active cancer that is considered more serious or harder to treat than multiple myeloma
• People who are likely to need treatment for their multiple myeloma within two months of starting the trial treatment
• People with a known history of HIV/AIDS, hepatitis B, or hepatitis C
• People who are planning to receive a yellow fever vaccine or any other live or weakened-virus vaccine during the study
• People who are known to be allergic to one of the trial medications called QS-21
• People who are unable to give their own informed consent to participate

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