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Iberdomide Maintenance Therapy for Multiple Myeloma
Study Summary
This trial will test if iberdomide is a safe and effective maintenance therapy for people with Multiple Myeloma who have had an Autologous Hematopoietic Stem Cell Transplant and have already had lenalidomide as maintenance therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My hemoglobin level is above 8 g/dL without recent blood transfusions.I had a specific bone marrow transplant for myeloma and am on a maintenance treatment.I have not had serious bleeding in the last 30 days.My multiple myeloma has spread to my brain or spinal cord.I have had an organ transplant and am on drugs to suppress my immune system.My kidney function, measured by creatinine clearance, is adequate.I am currently on long-term immunosuppressant medication.My white blood cell count is healthy without recent medication.Your liver enzymes (AST or ALT) are not more than 2.5 times the normal limit.I am a male and will not have unprotected sex or donate sperm while on the study treatment.Your corrected serum calcium level is lower than 13.5 mg/dL.Your bilirubin level in the blood should not be higher than twice the normal limit, unless you have Gilbert's disease.I am of childbearing potential and agree to follow strict pregnancy prevention measures.I have a history of specific blood disorders.I have had a stem cell transplant from a donor.I am not willing to take blood clot prevention medication during my iberdomide treatment.I have tested positive for HIV, hepatitis B, hepatitis C, or acute hepatitis A.I cannot or do not want to go back to the transplant center for treatment or follow-up.You have had a severe allergic reaction to thalidomide, lenalidomide, or pomalidomide in the past.I am able to care for myself but may not be able to do active work.I have recovered from side effects of previous treatments, except for mild neuropathy.I am a woman who can have children and have a negative pregnancy test.My blood clotting tests are within normal limits, unless I'm on blood thinners.I have not had cancer, except for treated skin cancer or in situ carcinoma, in the last 5 years.I do not have any ongoing serious infections.I had a blood clot while on blood thinners during previous IMiD therapy.My condition worsened after my last stem cell transplant.I am between 18 and 75 years old.My multiple myeloma diagnosis has been confirmed by tests.My platelet count is above 75,000 without recent transfusions.I've had 2-3 treatments for myeloma and a specific bone marrow transplant recently.
- Group 1: 2 to 3 prior lines of systemic anti-myeloma therapy +/- prior autoHCT
- Group 2: Single prior autoHCT with melphalan
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the participant size for this clinical investigation?
"This trial requires 86 participants, with adherence to the inclusionary criteria. Those hoping to partake in this study can do so from two different locations: Medical College of Wisconsin (Data Collection Only) situated in Milwaukee, WI or Memorial Sloan Kettering Westchester (Consent and Follow Up), located in Harrison, NJ."
Are there numerous medical institutions offering this research program in the state?
"Right now, this trial is welcoming participants from 10 different sites. Milwaukee, Harrison and Commack are among these locations as well as an additional 10 spots. To minimize travel demands, it would be wise to select the closest location possible if you decide to join in on the study."
Has Iberdomide been given the green light by the FDA?
"Here at Power, our collective opinion is that Iberdomide has a safety rating of 2 due to the current Phase 2 status and lack of efficacy evidence."
Is this research trial open to those in the geriatric population?
"This study is accessible to individuals aged 18 or above, and below the age of 75."
Are there any vacancies available for participants in this clinical examination?
"According to the info hosted on clinicaltrials.gov, this medical research is in need of subjects and has been actively recruiting since April 26th 2022 as evidenced by its most recent edit on June 10th 2022."
Is participation in this research endeavor open to the public?
"This research trial is searching for 86 participants aged 18 to 75 with an official diagnosis of multiple myeloma. The necessary criteria include: a neutrophil count higher than 1,000/mm3 without prior filgrastim use in the two weeks before evaluation; histological confirmation from the medical institution; Karnofsky performance at least 70%; recovery from all non-hematologic side effects due to earlier treatments (excepting peripheral neuropathy grade 2); platelet counts above 75,000/mm3 sans transfusions within seven days or thrombopoietin mimetics inside 28 days; hemoglobin levels over 8 g"
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