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:

• You have been diagnosed with a plasma cell cancer (such as multiple myeloma or a related condition) and your doctor has decided you need treatment.
• If joining Phase A of the trial, you must have already received at least 2 previous lines of treatment for your condition, as defined by international guidelines.
• If joining Phase A, your kidneys must be working well enough (above a certain threshold on a kidney function test — confirm with trial site).
• If joining Phase A, your doctor must consider you suitable to receive a standard high-dose chemotherapy preparation (melphalan 200 mg/m²).
• If joining Phase B of the trial, this stem cell transplant must be part of your very first round of treatment.
• Your white blood cell count (specifically neutrophils) must be at an acceptable level.
• Your platelet count (cells that help blood clot) must be at an acceptable level.
• Your liver function, as shown by blood tests, must be within an acceptable range.
• Your heart must be pumping strongly enough (at least 45% efficiency, measured by a heart scan).
• Your lung function tests must show your lungs are working above a minimum level.
• You must be well enough to carry out basic daily activities (your doctor will assess this using a standard scale).
• If you are a woman who could become pregnant, you must have a negative pregnancy test before starting treatment, and agree to use reliable contraception during the study.
• If you are a man taking part, you must agree to use reliable contraception during the study and for 3 months after treatment ends.
• You must be willing to follow the study's guidelines around fertility.
• You must be willing and able to sign a consent form showing you understand the study.
• If you have had or currently have another type of cancer, you may still be eligible if it is unlikely to affect the safety or results of this study (confirm with trial site).

Who may not be able to join:

• Your cancer has gotten worse or come back between your initial screening appointment and the planned start of chemotherapy.
• You have a significant heart condition, such as severe heart failure, a serious heart muscle disease, a heart attack within the last 6 months, uncontrolled chest pain, uncontrolled high blood pressure, serious irregular heartbeats, or an abnormal heart electrical reading above a certain level.
• You are HIV positive, unless you meet all of the following: your immune cell count is above a safe level, your virus levels are undetectable, you are on a modern HIV treatment that does not interfere with the study drugs, and you have no untreated HIV-related infections.
• You currently have or recently had an active Hepatitis B infection (certain exceptions may apply depending on your test results — confirm with trial site).
• You have Hepatitis C, unless it has been fully cleared from your body for at least 12 weeks after completing antiviral treatment.
• You have been diagnosed with certain specific related conditions including POEMS syndrome, AL amyloidosis, or Waldenström's macroglobulinemia.
• You have another medical condition or active infection that could interfere with the study or put you at risk.
• There are concerns that you may not be able to follow the study procedures for any reason, including health or personal circumstances (confirm with trial site).
• You are currently pregnant, as the treatment could harm an unborn baby.
• You are currently breastfeeding, as the treatment could potentially affect a nursing infant.

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