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 to 72 who have been newly diagnosed with symptomatic multiple myeloma, where the disease can be measured through specific blood, urine, or imaging tests at the time of diagnosis.
• People whose myeloma is considered high-risk, based on specific disease staging systems (R-ISS or ISS) or the presence of certain high-risk genetic features in the myeloma cells (such as del(17p), t(4;14), t(14;16), t(14;20), or extra copies of 1q21).
• Both English and non-English speaking patients are welcome.
• People who have a reasonably good level of physical functioning, as measured by standard medical performance scales (Karnofsky score of at least 70%, or ECOG score of 2 or less).
• People who have already undergone a stem cell transplant (using their own stem cells) with a conditioning treatment of Melphalan alone, or Melphalan combined with Busulfan, and whose blood counts have recovered adequately after the transplant without needing growth factors or transfusions in the 7 days before testing.
• People whose myeloma responded at least partially to treatment before starting the maintenance phase of this trial.
• People whose kidneys, liver, and other major organs are functioning at an adequate level, based on specific blood test results (confirm exact values with trial site).
• People who are able to provide written consent, or have a legal representative who can do so on their behalf.
• Women of childbearing potential who are not pregnant or breastfeeding, have a negative pregnancy test before and during treatment, and commit to using two reliable forms of contraception (or remain abstinent) during the study and for at least 5 months after the last dose of Isatuximab.
• Men who are able to father children and agree to use accepted contraception methods and not donate sperm during the study and for at least 5 months after the last dose of Isatuximab.

Who may not be able to join:

• People whose myeloma has progressed or worsened (as defined by standard medical criteria) before the maintenance therapy phase begins.
• People who have taken part in another clinical trial or received another experimental drug within 14 days or 5 half-lives of that drug before starting this trial (exceptions may be considered by the lead investigator).
• People who have had serious allergic reactions to drugs that are chemically similar to the study medications, or who have known intolerances to certain ingredients in the study drugs that cannot be managed with pre-medications (confirm specific ingredients with trial site).
• People who have a known allergy or severe skin reaction to thalidomide or lenalidomide.
• People who currently have an active infection that requires treatment.
• People with certain serious uncontrolled health conditions, including very high blood pressure that does not respond to medication, severe heart failure, a recent heart attack, liver cirrhosis, or significant mental health or cognitive conditions that could affect their ability to follow the trial requirements.
• People who have had major surgery within the 4 weeks before starting the trial treatment.
• People who are HIV-positive or have an active hepatitis A, B, or C infection.

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