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Lenalidomide +/- Ixazomib + Dexamethasone for Multiple Myeloma
Study Summary
This trial is testing how well lenalidomide alone or with ixazomib citrate and dexamethasone works in treating patients with multiple myeloma that remains after a donor stem cell transplant.
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 2021 Phase 2 trial • 8 Patients • NCT03202628Trial Design
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- I haven't had radiotherapy in the last 14 days, or if it was a small area, in the last 7 days.I do not have any serious health or mental conditions that could stop me from completing the treatment.I haven't taken any antibiotics, antivirals, or antifungals in the last two weeks.Your heart's electrical activity, measured by a test called an electrocardiogram, shows a longer than normal QT interval.I am currently taking lenalidomide and can handle a higher dose.My condition has not worsened while on lenalidomide.Your bilirubin levels must be within a certain range.You are expected to live for at least 3 more months.My diabetes is not under control.I do not have uncontrolled heart conditions like severe heart failure or recent heart attacks.I have severe nerve damage in my hands or feet, or moderate with pain.I am not pregnant or breastfeeding.I have mild to no diarrhea without taking medication.I have signs of residual disease detectable by specific blood tests or bone marrow analysis.I haven't taken specific strong medications or herbal supplements in the last 14 days.I finished my first treatment for myeloma and started maintenance therapy with Revlimid.I am able to care for myself and perform daily activities.I agree to use effective contraception or practice true abstinence during and up to 90 days after the study.I am a woman who cannot become pregnant or agrees to use 2 birth control methods or practice true abstinence during the study.My cancer has worsened despite being on lenalidomide.I have not had major surgery in the last 2 weeks.Your platelet count is 75 or more billion per liter.I have been on lenalidomide for 3 to 4 months.I haven't had any cancer besides nonmelanoma skin cancer or carcinoma in situ, or if I have, it was more than 2 years ago and fully treated.I started lenalidomide maintenance within 3 months after my stem cell transplant.Your absolute neutrophil count is at least 1.0 x 10^9/L.My kidney function, measured by creatinine clearance, is normal or near normal.I do not have an active infection, hepatitis B or C, or HIV.Your liver enzymes (AST and ALT) should not be more than three times the upper limit of normal.Your hemoglobin level is at least 8 grams per deciliter.You have had an allergic reaction to mannitol in the past.I have started or received a multi-drug treatment after my transplant, except for lenalidomide maintenance.My cancer has spread to my brain or spinal cord.I have a GI condition or had a procedure that affects my ability to take pills.
- Group 1: Arm II (lenalidomide)
- Group 2: Arm I (ixazomib citrate, lenalidomide, dexamethasone)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- 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 many participants are currently in this clinical research study?
"This clinical trial has already concluded its recruitment process. Initially posted on March 2nd 2015, the last edit was made to this study's page on October 5th 2021. However, there are currently 822 trials open for enrolment related to multiple myeloma and 714 studies accepting participants for Ixazomib Citrate treatments."
What medical purposes is Ixazomib Citrate commonly employed to treat?
"Ixazomib Citrate has been proven successful in treating ophthalmia, sympathetic disorders, those with a history of at least two systemic chemotherapy regimens, and branch retinal vein occlusion."
Is recruitment currently open for this experiment?
"Sadly, this experiment is no longer enrolling participants. Initially posted on March 2nd 2015, the study was most recently updated October 5th 2021. For those seeking alternatives there are 822 clinical trials actively recruiting patients with multiple myeloma and 714 studies accepting applicants for Ixazomib Citrate treatments."
Has the FDA granted authorization to Ixazomib Citrate?
"Our team at Power believes that Ixazomib Citrate carries a level of safety rated as 2. This is because this medication has only successfully passed Phase 2 trials, which indicate the presence of some evidence for its security, but no proof regarding its efficacy yet."
Are there any related investigations that have utilized Ixazomib Citrate?
"Currently, there are 714 trials dedicated to Ixazomib Citrate; 168 of those studies have progressed into the third phase. Although the majority of these research projects are conducted in Joliet, Illinois, a total of 25 980 sites around the world offer patients this treatment."
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