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Corticosteroid
Lenalidomide +/- Ixazomib + Dexamethasone for Multiple Myeloma
Phase 2
Waitlist Available
Led By Andrzej Jakubowiak
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who completed induction treatment followed by autologous stem cell transplant as initial therapy for symptomatic myeloma as per IMWG criteria and initiated Revlimid (lenalidomide) maintenance
Patients must have initiated lenalidomide maintenance at approximately 3 months post autologous stem transplant (preferably 70-90 but not more than 120 days)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
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.
Who is the study for?
This trial is for multiple myeloma patients with residual disease after a donor stem cell transplant. They must have been on lenalidomide maintenance for 3-4 months, have measurable residual disease, and proper organ function. Women of childbearing potential and men must agree to effective contraception methods. Exclusions include uncontrolled conditions like heart issues or diabetes, recent infections or surgeries, other cancer treatments within 30 days, certain drug allergies, severe neuropathy, CNS involvement, and QTc >470 msec.Check my eligibility
What is being tested?
The study compares the effectiveness of lenalidomide alone versus in combination with ixazomib citrate and dexamethasone in treating remaining multiple myeloma post-transplant. Lenalidomide may boost the immune system's ability to kill cancer cells; ixazomib could interfere with cancer cell growth; dexamethasone aims to stop cancer spread.See study design
What are the potential side effects?
Potential side effects include immune system complications due to lenalidomide; gastrointestinal issues from ixazomib citrate affecting absorption or tolerance; blood sugar changes from dexamethasone use; fatigue; infection risk increase due to weakened immunity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I finished my first treatment for myeloma and started maintenance therapy with Revlimid.
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I started lenalidomide maintenance within 3 months after my stem cell transplant.
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My condition has not worsened while on lenalidomide.
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I am able to care for myself and perform daily activities.
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I am currently taking lenalidomide and can handle a higher dose.
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My kidney function, measured by creatinine clearance, is normal or near normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of MRD between the two arms, as measured by flow cytometry and sequencing
Secondary outcome measures
Duration of response (MRD-negative disease)
Estimated OS
Estimated PFS
+4 moreOther outcome measures
Markers of response
Side effects data
From 2021 Phase 2 trial • 8 Patients • NCT03202628100%
Fatigue
100%
Neutrophil count decreased
100%
White blood cell decreased
88%
Platelet count decreased
75%
Diarrhea
75%
Lymphocyte count decreased
63%
Constipation
63%
Peripheral sensory neuropathy
50%
Nausea
50%
Creatinine increased
25%
Hyperglycemia
13%
Urinary tract infection
13%
Wrist fracture
13%
Cardiac disorders - Other, specify
13%
Vomiting
13%
Anorexia
13%
Insomnia
13%
Hypoxia
13%
Resp, thoracic, mediastinal - Oth spec
13%
Hypoglycemia
13%
Tremor
13%
Anemia
13%
Blood and lymph sys disorders - Oth Spec
13%
Febrile neutropenia
13%
Fever
13%
Alkaline phosphatase increased
13%
Pneumonitis
13%
Rash maculo-papular
13%
Thromboembolic event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (ixazomib citrate, lenalidomide, dexamethasone)Experimental Treatment3 Interventions
Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only).
Group II: Arm II (lenalidomide)Active Control1 Intervention
Patients receive lenalidomide PO as in Arm I.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Ixazomib
FDA approved
Lenalidomide
FDA approved
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,735 Total Patients Enrolled
16 Trials studying Multiple Myeloma
1,927 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,675 Previous Clinical Trials
40,926,935 Total Patients Enrolled
581 Trials studying Multiple Myeloma
189,159 Patients Enrolled for Multiple Myeloma
Multiple Myeloma Research FoundationOTHER
10 Previous Clinical Trials
3,535 Total Patients Enrolled
10 Trials studying Multiple Myeloma
3,535 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (lenalidomide)
- Group 2: Arm I (ixazomib citrate, lenalidomide, dexamethasone)
Awards:
This trial has 3 awards, including:- 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.
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.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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