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SPd vs EloPd Chemotherapy for Multiple Myeloma
Study Summary
This trial will compare two different chemotherapy regimens for multiple myeloma patients who have received one to four prior treatments. The first regimen contains the drugs pomalidomide, dexamethasone, and a monoclonal antibody. The second regimen contains the drugs elotuzumab, pomalidomide, and dexamethasone. The trial will measure efficacy, safety, and quality of life.
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.Side effects data
From 2015 Phase 2 trial • 36 Patients • NCT02011113Trial Design
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- I have been treated with a drug like selinexor before.I can take aspirin or am fully anticoagulated if I have a history of blood clots.I might be using alternative blood thinners as decided by my doctor.I have had 1 to 4 treatments for my multiple myeloma.I am experiencing complications from a stem cell transplant.I haven't had cancer treatments or high dose steroids in the last 2 weeks.My blood counts are within normal ranges as of last week.I have a serious heart condition.I have been diagnosed with active systemic light chain amyloidosis.I have not had a stem cell transplant within the last 2 months (autologous) or 4 months (allogeneic).My multiple myeloma has returned or didn't respond to treatment and can be measured.I can take care of myself but might not be able to do heavy physical work.I haven't had a platelet transfusion in the last week.I had hepatitis C but was treated successfully and now have an undetectable viral load.I am a woman who can have children and have had two negative pregnancy tests before starting the study treatment.I am allergic or cannot take certain medications needed for the trial.My side effects from previous treatments are mild as of the first treatment day.I have HIV with a CD4 count ≥350, no AIDS infections in the last year, and have been on ART for 4 weeks.I have trouble swallowing pills due to a stomach or gut problem.I have not had major surgery in the last 4 weeks.I am willing and able to follow the study's requirements.My kidney function is normal as tested within the last 28 days.I haven't received blood cell growth support in the last 2 weeks.I haven't had a blood transfusion in the last 2 weeks.My liver is functioning well, as tested within the last 28 days.I am 18 years old or older.I have hepatitis B but have been on antiviral therapy for over 8 weeks and my viral load is under 100 IU/mL.I do not have an active infection needing IV drugs within the last week.I have taken Pomalidomide and/or Elotuzumab.My condition is smoldering multiple myeloma.I have a history of brain or spinal cord cancer.I have been diagnosed with plasma cell leukemia.
- Group 1: Elotuzumab, Pomalidomide and Dexamethasone (EloPd)
- Group 2: Selinexor, pomalidomide and dexamethasone (SPd)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Is Pomalidomide a danger to patients?
"There is some evidence that Pomalidomide is effective, as this is a Phase 3 trial. Furthermore, multiple rounds of data support Pomalidomide's safety, leading to a score of 3."
What diseases or conditions does Pomalidomide commonly help with?
"ophthalmia, sympathetic is often treated with Pomalidomide. However, Pomalidomide can also be used to ameliorate other issues such as macular edema, branch retinal vein occlusion, and communicable diseases."
Can you give me a ballpark number of the hospitals participating in this research?
"There are 25 sites that are currently enrolling patients for this clinical trial. The sites are located in cities such as West Reading, Greenville, Winston-Salem and 25 other locations. It would be best to choose the location closest to you to reduce travel time and effort, if you do decide to participate."
What other scientific investigations have used Pomalidomide as a research drug?
"First appearing in medical literature in 2002, pomalidomide has been studied in 1152 completed clinical trials. Of these, 629 are active and ongoing, with several originating from West Reading, Pennsylvania."
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