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Lenalidomide-Dexamethasone-DLI for Multiple Myeloma
Study Summary
This trial is a two-step treatment using Lenalidomide and Dexamethasone followed by Donor Leukocyte Infusions to offer an optimal disease control strategy in relapsed patients. The cytoreductive and immunomodulatory effects of Len are expected to induce a permissive immunological environment for the immunotherapeutic activity of DLIs to develop. This treatment combination has the potential to further improve depth of myeloma response, delay myeloma progression and improve patient survival.
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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Who is running the clinical trial?
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- I am between 18 and 65 years old.Your bilirubin, AST and ALT levels are too high, unless it's due to a condition called Gilbert's disease or hemolysis. Your alkaline phosphatase level is also too high.I do not have an active infection with HIV, HTLV-1 or 2, hepatitis B, or hepatitis C.You are currently struggling with drug or alcohol abuse.I have moderate to severe or uncontrolled GVHD.My myeloma has returned after my first stem cell transplant.I do not have another cancer with a low survival rate, except for certain treated early-stage cancers.I am not pregnant, surgically sterile, or have been postmenopausal for at least a year.I am a woman who could get pregnant and plan to try during or within 4 weeks after the study.My heart, lungs, or kidneys are not working well.I had a stem cell transplant from a donor after my own cells' transplant didn't work.You have any health issues or test results that could change how you respond to treatment or follow the study's plan.I received Len therapy after a stem cell transplant, before any relapse.You have a detectable disease based on specific criteria at the time of a relapse.I agree to use effective birth control methods during and after taking Len.You are allergic to Lenalidomide or Dexamethasone.My condition did not improve with Len treatment before a stem cell transplant.I need assistance with my daily activities.I have severe or uncontrolled chronic GVHD.My condition worsened within 6 months after my transplant.I agree to follow the pregnancy testing schedule as required.It's estimated that you have less than 6 months to live after starting treatment with Len and Dex.
- Group 1: Lenalidomide-Dexamethasone-DLI
- 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
How is the Lenalidomide-Dexamethasone-DLI protocol typically implemented?
"Ocular inflammation, empathetic response, inadequate responses to at least two previous chemotherapy protocols and branch retinal vein occlusion can be alleviated with the Lenalidomide-Dexamethasone-DLI medication regimen."
Is the age limit of this research confined to those who are under 45 years of age?
"This clinical trial is open to patients who have attained the age of consent and are below 65 years old."
Are there any openings available to join this clinical venture?
"For consideration in this medical trial, applicants must have been diagnosed with multiple myeloma and should be between 18 to 65 years old. Presently, around 10 participants are being sought."
Has the Lenalidomide-Dexamethasone-DLI combination been given regulatory clearance by the FDA?
"Given the Phase 2 status of this study, our team at Power has assigned Lenalidomide-Dexamethasone-DLI a safety rating of 2 due to limited evidence that it is safe and effective."
To what extent have Lenalidomide-Dexamethasone-DLI trials been conducted?
"At present, 696 medical studies are underway to analyze the efficacy of Lenalidomide-Dexamethasone-DLI. 166 trials have progressed into Phase 3 and while Mishawaka, Indiana is housing a large number of trials for this treatment option - 25489 locations worldwide are also conducting research on it's effectiveness."
What is the size of the participant pool for this research endeavor?
"At the present moment, recruitment for this trial has been paused. Initially opening on February 12th 2018 and last edited on July 19th 2022, there are currently 1,039 trials actively recruiting patients with multiple myeloma and 696 studies utilizing Lenalidomide-Dexamethasone-DLI therapy that are accepting volunteers."
Are there any opportunities for potential participants to join this experiment?
"Data hosted on clinicaltrials.gov displays that this specific medical trial is not actively looking for participants at the present moment, having been last edited in July 2019. Nevertheless, there are still 1735 other trials which are open to recruitment currently."
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