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Ibrutinib + Revlimid/Dexamethasone for Multiple Myeloma
Study Summary
This trial will test the safety and effectiveness of a new combination therapy for multiple myeloma.
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 have an infection with HIV, HCV, or HBV.You have had certain syndromes and disorders in the past.I have a serious liver condition that is affecting me now.I am 18 years old or older.I have not taken strong CYP3A inhibitors recently.I have a known bleeding disorder.My condition worsened after my last treatment.My condition worsened within 2 months after my last treatment.I had radiotherapy less than 3 weeks ago, but it was for a single spot or bone fracture.I have not had a stroke or brain bleed in the last 6 months.I have not had major surgery in the last 4 weeks.I have not had chemotherapy recently.I have had cancer before, but it might still be okay.My diabetes is not well-managed.I have a heart condition that affects my daily life.I have an ongoing infection that is not under control.My blood counts are healthy without needing transfusions or medications to help.I am not pregnant.I have not received any live vaccines in the last 4 weeks.I have lingering side effects from previous cancer treatments.I am fully active or can carry out light work.I have symptoms from my multiple myeloma, which can be measured.My condition did not worsen while on lenalidomide doses over 10mg.I have not taken ibrutinib or drugs targeting B-cell signals.I have not taken antibiotics for an infection in the last 14 days.I have had daratumumab treatment and an allogeneic stem cell transplant.My blood clotting tests are within normal limits, unless I'm on blood thinners for health reasons.Your blood test results are within certain limits.I cannot swallow pills or have a major stomach condition.I do not have severe numbness, tingling, or pain in my hands or feet.I do not have any severe illnesses or conditions that could threaten my life.
- Group 1: Dose Escalation
- Group 2: Dose Expansion
- 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
Are there numerous locations in Canada running this experiment?
"The trial is being conducted in 5 different hospitals, with notable sites including Loyola University Medical Centre, The Ohio State University Wexner Medical Center/James Cancer Hospital and Dana Farber Cancer Institute."
Are there any vacancies available for participants in this experiment?
"Yes, according to clinicaltrials.gov's information, this trial is still actively seeking patients. The research was established on August 29th 2019 and last updated July 13th 2022. A total of 28 individuals need to be enrolled from 5 sites in order for the study to continue."
What is the upper limit of participants in this clinical experiment?
"28 qualified participants are necessary to initiate this clinical trial, which can be accessed at two separate sites - Loyola University Medical Center in Maywood and The Ohio State University Wexner Medical Center/James Cancer Hospital in Columbus."
Has Ibrutinib been sanctioned by the Food and Drug Administration?
"Our assessment of Ibrutinib's safety was a rating of 1, as this is an early phase trial and the clinical data supporting efficacy and safety is currently limited."
What are the desired outcomes of this investigation?
"According to the trial's sponsor, Pharmacyclics LLC., the primary measure of success will be Objective Response Rate. Secondary metrics include Duration of Response (time between response initiation and disease progression or death), Progression Free Survival (time from registration until deterioration/death due to any cause) and Overall Survival (total time alive as measured from registration). These outcomes will be tracked over a 19 month period."
In what instances is Ibrutinib typically recommended?
"Ibrutinib is commonly used to treat ophthalmia, sympathetic and a variety of other conditions such as two prior systemic chemotherapy regimens, branch retinal vein occlusion or macular edema."
Are there any existing reports of Ibrutinib being tested in prior trials?
"At present, the number of ongoing Ibrutinib trials stands at 838 with 188 in Phase 3. While there is a concentration of such research near Ascoli Piceno, Provincia, data indicates that over 32 thousand sites around the globe are conducting clinical studies involving this medication."
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