Study of Iberdomide for People with Multiple Myeloma After Stem Cell Transplant
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT05354557
This study is testing if iberdomide is a safe and effective ongoing treatment for people with Multiple Myeloma who have had a stem cell transplant and previously used lenalidomide as maintenance therapy.
Patient Parameters
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Program Overview
The study aims to determine if iberdomide can be a safe and effective maintenance treatment for people with Multiple Myeloma who have undergone a stem cell transplant and have already used lenalidomide. Participants will continue receiving iberdomide as long as it benefits them and will stop if the disease progresses or if there are unacceptable side effects. Follow-up will be according to standard care, and no extra research samples will be needed.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of multiple myeloma.
- Aged between 18 and 75 years.
- Good overall health with a performance score of 70 or higher.
- Recovery to near-normal levels from any side effects of previous treatments, except for mild nerve damage.
- Meet specific blood test criteria, including:
- Neutrophil count of at least 1,000/mm3 without recent growth factor use.
- Platelet count of at least 75,000/mm3 without recent transfusions.
- Hemoglobin level above 8 g/dL without recent transfusions.
- Kidney function with creatinine clearance of at least 30 mL/min.
- Normal calcium, liver enzymes, and bilirubin levels.
- Normal blood clotting times unless on blood thinners.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
Cohort 1:
- Had a single stem cell transplant with specific conditions within 12 months of starting treatment.
- Used lenalidomide maintenance therapy for at least 6 months.
- Achieved a very good partial response or less to treatment.
- Within 12 months of their stem cell transplant.
Cohort 2:
- Had 2 to 3 previous treatments for multiple myeloma, with or without a prior stem cell transplant.
- Used lenalidomide maintenance therapy after a previous treatment.
- Had a recent high-dose melphalan stem cell transplant within the last 2-6 months.
Pregnancy:
- Women of childbearing potential must have two negative pregnancy tests before starting treatment and agree to ongoing testing.
- Must use two forms of contraception or practice true abstinence.
- Men must use condoms during sexual contact and agree not to donate sperm.
- All participants must agree not to donate blood during and after treatment.
Exclusion Criteria
- Previous allogeneic stem cell transplant.
- Disease progression after the most recent stem cell transplant.
- Active central nervous system involvement with multiple myeloma.
- Previous organ transplant requiring immunosuppressive therapy.
- History of blood clots while on full anticoagulation during previous treatment with similar drugs.
- Unwilling to take blood clot prevention medication during iberdomide treatment.
- Recent significant bleeding.
- History of certain blood disorders or amyloidosis.
- Ongoing treatment with chronic immunosuppressants.
- Positive for HIV, hepatitis B, or C, or acute hepatitis A.
- Other cancers treated less than 5 years ago, unless approved by the study investigator.
- Allergic reactions to similar drugs.
- Uncontrolled infections at the time of enrollment.
- Serious medical or psychiatric conditions that may interfere with participation.
- Unwilling or unable to provide informed consent.
- Unable or unwilling to return to the transplant center for treatment and follow-up.
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