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IRD Regimen for Multiple Myeloma
Study Summary
This trial is testing a new treatment for people who have had stem cell transplants, to see if it can help prolong the time they are disease-free.
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 not pregnant or breastfeeding.I am scheduled for or have had two stem cell transplants using my own cells.Your blood and organ function should be within specific ranges, and you should not have received platelet transfusions within 7 days before the study.I am not planning to receive any other cancer treatments until 28 days after my transplant.I do not have severe heart issues or uncontrolled blood pressure problems.I have an active hepatitis infection or am HIV positive.I do not have any stomach or intestine problems that could affect how a medicine is absorbed.I agree to follow the study's rules about preventing pregnancy.I have been diagnosed with symptomatic multiple myeloma.I can take care of myself and perform daily activities.I am following strict birth control and pregnancy testing as required if I can have children.I have had plasma cell leukemia or myeloma that spread to the brain.I don't have any serious health or mental conditions that could stop me from completing the treatment.I have severe nerve damage in my hands or feet, or moderate with pain.I have not had major surgery in the last 2 weeks.I started my first treatment for multiple myeloma between 2 to 16 months ago and have completed at least two cycles.I am not receiving treatment for any cancer other than multiple myeloma or secondary amyloidosis.I am between 18 and 70 years old.I have had an organ transplant and am on immunosuppressive drugs.I have not needed antibiotics for a serious infection in the last 2 weeks.My multiple myeloma has worsened before joining this study.
- Group 1: Consolidation: Ixazomib, Lenalidomide, & Dexamethasone
- Group 2: Maintenance Arm 1: Ixazomib
- Group 3: Maintenance Arm 2: Lenalidomide
- 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 opportunities available to participation in this medical trial currently?
"According to the data found on clinicaltrials.gov, patient recruitment for this trial has ceased; originally posted in January of 2015 and last edited on November 8th 2022. However, there are presently 1,522 other studies recruiting participants across the globe."
What detrimental effects might Lenalidomide have on human health?
"Lenalidomide has not been proven to be efficacious yet, hence it was rated a 2 on the safety scale. This is because this trial is currently in its second phase of development where some data exists validating its security but none verifying effectiveness."
What other research endeavors have been conducted centered around Lenalidomide?
"At present, there are 715 studies in progress for Lenalidomide. Out of these research initiatives, 168 have reached Phase 3 status. Although the majority of trials related to this treatment operate from Joliet, Illinois - an overall total of 26000 sites are running these experiments."
Are there any age restrictions for participating in this scientific investigation?
"As indicated by the eligibility requirements, individuals aged 18 to 70 are encouraged to participate in this medical trial."
What medical conditions has Lenalidomide been utilized to treat?
"Lenalidomide has been demonstrated to have a positive effect on treating and managing the symptoms of ophthalmia, sympathetic disorders, two or more rounds of chemotherapy, and branch retinal vein occlusions."
How many participants have been selected to take part in this clinical study?
"This clinical trial is now closed for patient recruitment. It was first published on January 20th 2015 and the last update recorded was November 8 2022. For those interested in other options, there are currently over 800 trials actively recruiting patients with multiple myeloma and 715 studies involving lenalidomide that require participants."
Are there any research centers in North America that are performing this investigation?
"Ten different clinical trial sites are currently accepting participants, located in Duarte, Denver and Atlanta as well as other cities. To reduce the need to travel far away for appointments, it is advised that patients choose a clinic close by when enrolling."
Is it possible for me to enroll in this experiment?
"To be considered for inclusion in this trial, potential participants must have multiple myeloma and fall between the ages of 18 and 70. Ultimately, 236 individuals will complete the study."
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