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Pomalidomide for Waldenstrom's Macroglobulinemia
Study Summary
This trial is testing the side effects and best dose of pomalidomide for treating patients with Waldenstrom macroglobulinemia who have relapsed or are refractory.
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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Who is running the clinical trial?
Media Library
- My Waldenstrom's macroglobulinemia has returned or didn't respond to my first treatment.I can take aspirin daily or, if allergic, I can use an alternative like warfarin or heparin.Your platelet count is at least 20,000 per microliter.I have previously used pomalidomide.I stopped all cancer treatments including radiation, hormonal therapy, and surgery at least 4 weeks ago.You have enough white blood cells called neutrophils in your body.I am committed to following strict birth control measures or abstinence as required.I am known to be positive for HIV or hepatitis A, B, or C.I am not pregnant or breastfeeding, or I agree not to breastfeed while on pomalidomide and for 28 days after.Your kidneys work well enough to clear at least 45 milliliters of creatinine from your body every minute.Your bilirubin levels in your blood are not too high.I am not using any other cancer treatments.I haven't used any experimental drugs or therapies in the last 28 days.Your AST and ALT levels in your blood should not be higher than two times the normal limit.Your blood creatinine level is less than or equal to 2.0 mg/dL.My neutrophil or platelet counts are low, but not due to Waldenström's macroglobulinemia.I developed a peeling rash from thalidomide or similar medications.I do not have severe numbness or pain in my hands or feet.You are allergic to thalidomide or lenalidomide.I can take care of myself but might not be able to do heavy physical work.I have been cancer-free for 5 years, except for certain skin cancers or early-stage cervical/breast cancer.
- Group 1: Treatment (pomalidomide)
- 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 sample size of participants in this research?
"Currently, this trial is not enrolling patients. This study was published on October 6th 2010 and the latest update occurred on 11 Oct 2022. However, there are 83 clinical trials currently recruiting for those with Waldenstrom Macroglobulinemia and 87 studies searching for participants to use Pomalidomide."
Has there been prior experimentation with Pomalidomide in a clinical setting?
"At the moment, 87 studies involving pomalidomide are in progress. 10 of these exist in Phase 3 and 2794 locations worldwide are conducting clinical trials for this medication. Houston is particularly active with regards to research on Pomalidomide."
Has the Food and Drug Administration sanctioned the use of pomalidomide?
"Since this is a Phase 1 trial, with limited data concerning its safety and efficacy, Pomalidomide's risk score was assigned to be a 1."
Is enrollment for this study open to participants at present?
"Clinicaltrials.gov data reveals that this clinical trial, initially posted on October 6th 2010 and last modified on October 11th 2022, is not currently enrolling participants. However, there are 170 other studies actively seeking patients at the moment."
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