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Corticosteroid
IRD Regimen for Multiple Myeloma
Phase 2
Waitlist Available
Led By Ravi Vij, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2
Women of childbearing potential must follow pregnancy testing requirements as outlined in the Revlimid REMS program material. This is defined as either committing to continued abstinence from heterosexual intercourse or beginning TWO acceptable methods of contraception (one highly effective method and one additional effective method AT THE SAME TIME) at least 28 days prior to the start of lenalidomide, for the duration of study participation, and for 28 days following the last dose of lenalidomide. Women of childbearing potential must also agree to ongoing pregnancy testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after the completion of maintenance treatment (estimated to be day 1125 of maintenance treatment)
Awards & highlights
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.
Who is the study for?
Adults aged 18-70 with symptomatic multiple myeloma, who've had initial therapy and are within 2-16 months of starting it. They must have good organ function, not be pregnant or breastfeeding, agree to contraception if applicable, and follow REMS program requirements for lenalidomide. Exclusions include other active cancers needing treatment, recent major surgery or serious infections, certain heart conditions, severe neuropathy among others.Check my eligibility
What is being tested?
The trial is testing the IRD regimen (Ixazomib, Lenalidomide, Dexamethasone) after stem cell transplantation in multiple myeloma patients. Post four cycles of IRD treatment participants will randomly receive maintenance therapy with either Ixazomib or Lenalidomide to see which helps keep the disease at bay longer.See study design
What are the potential side effects?
Possible side effects include low blood counts leading to increased infection risk; nerve damage causing pain or numbness; digestive issues like nausea and diarrhea; rash; fatigue; liver problems indicated by abnormal tests; and potential blood clots due to lenalidomide.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
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I am following strict birth control and pregnancy testing as required if I can have children.
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I am between 18 and 70 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days after the completion of maintenance treatment (estimated to be day 1125 of maintenance treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after the completion of maintenance treatment (estimated to be day 1125 of maintenance treatment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Improvement in Minimal Residual Disease (MRD)
Secondary outcome measures
Association of Overall Survival With MRD-negativity
Association of Overall Survival With MRD-positivity
Association of Progression-free Survival With MRD-negativity
+11 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Maintenance Arm 2: LenalidomideExperimental Treatment1 Intervention
Lenalidomide will be administered daily continuously for a 28-day cycle at a starting dose of 10 mg. If lenalidomide is tolerated well (i.e. no dose modification required) during the first three cycles, lenalidomide dose will be increased to 15 mg daily and will continue until patient progresses or experiences an unacceptable toxicity.
Group II: Maintenance Arm 1: IxazomibExperimental Treatment1 Intervention
Ixazomib will be administered on Days 1, 8, and 15 of a 28-day cycle at a starting dose of 4 mg until patient progresses or experiences an unacceptable toxicity.
Group III: Consolidation: Ixazomib, Lenalidomide, & DexamethasoneExperimental Treatment3 Interventions
Consolidation therapy will begin between Day 80 and Day 120 following ASCT and will consist of four 28-day cycles of IRD (ixazomib, lenalidomide, & dexamethasone). Barring dose modifications for toxicity, 4 mg of ixazomib and 40 mg of dexamethasone will be administered on Days 1, 8, and 15, and 15 mg of lenalidomide will be administered on daily on Days 1-21.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib
2017
Completed Phase 4
~3370
Dexamethasone
2007
Completed Phase 4
~2590
Lenalidomide
2005
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,473 Total Patients Enrolled
31 Trials studying Multiple Myeloma
1,981 Patients Enrolled for Multiple Myeloma
Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
46,678 Total Patients Enrolled
82 Trials studying Multiple Myeloma
9,826 Patients Enrolled for Multiple Myeloma
Multiple Myeloma Research ConsortiumNETWORK
20 Previous Clinical Trials
1,122 Total Patients Enrolled
19 Trials studying Multiple Myeloma
1,069 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Consolidation: Ixazomib, Lenalidomide, & Dexamethasone
- Group 2: Maintenance Arm 1: Ixazomib
- Group 3: Maintenance Arm 2: Lenalidomide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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