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Corticosteroid
Triple Drug Regimen for Multiple Myeloma
Phase 1 & 2
Waitlist Available
Led By Shaji Kumar
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of multiple myeloma (MM) with deletion 17p (del17p) or monosomy 17 by fluorescence in situ hybridization (FISH) who have received at least one line of therapy
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing idasanutlin, ixazomib citrate, and dexamethasone to see if they're effective in treating patients with multiple myeloma that has returned.
Who is the study for?
This trial is for patients with relapsed multiple myeloma, specifically those who have certain genetic changes (deletion 17p or monosomy 17). Participants must have had at least one prior therapy, adequate organ function, and agree to use birth control. Excluded are those with significant neuropathy, recent major surgery, other active cancers needing treatment, known allergies to study drugs, heart conditions within the last six months, uncontrolled infections or diseases that could affect participation.Check my eligibility
What is being tested?
The trial is testing a combination of idasanutlin and ixazomib citrate with dexamethasone in patients whose multiple myeloma has returned. It aims to find the best dose while assessing how these drugs might stop cancer growth by killing cells or preventing them from dividing and spreading.See study design
What are the potential side effects?
Potential side effects include reactions related to chemotherapy such as fatigue, nausea, risk of infection due to low blood counts; nerve damage symptoms like numbness or pain; possible liver issues indicated by elevated enzymes; gastrointestinal problems including difficulty swallowing; and increased risk of bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have multiple myeloma with a specific genetic change and have undergone treatment.
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I am able to care for myself and perform daily activities.
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My kidneys are functioning well enough, with a creatinine clearance of at least 30 mL/min.
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I am willing to give bone marrow and blood samples for research.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 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 Confirmed Response, Defined as a Patient Who Has Achieved a Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) on Two Consecutive Evaluations (Phase II)
The Number of Participants Who Experienced Dose Limiting Toxicities. Maximum Tolerated Dose (MTD) of Ixazomib Citrate and Idasanutlin in Combination With Dexamethasone (Phase I)
Secondary outcome measures
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Overall Survival (Phase II)
+3 moreOther outcome measures
Changes in Macrophage Inhibitory Cytokine-1 (MIC) Levels
Impact of MDM2 Inhibition on Activation of p53 and Clonal Selection
Potential Biomarkers Associated With Response Determined Using Gene Expression Profiling
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ixazomib citrate, idasanutlin, dexamethasone)Experimental Treatment5 Interventions
Patients receive ixazomib citrate PO on days 1, 8, and 15 and idasanutlin PO QD on days 1-5 every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive dexamethasone PO on days 1, 8, 15, and 22 every 28 days for 12 courses at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Idasanutlin
2018
Completed Phase 2
~380
Ixazomib Citrate
2012
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,751 Total Patients Enrolled
76 Trials studying Multiple Myeloma
9,678 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,120 Total Patients Enrolled
578 Trials studying Multiple Myeloma
188,697 Patients Enrolled for Multiple Myeloma
Shaji KumarPrincipal InvestigatorMayo Clinic
15 Previous Clinical Trials
1,661 Total Patients Enrolled
15 Trials studying Multiple Myeloma
1,661 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any major health issues that would prevent me from joining the trial.I have moderate to severe nerve damage in my hands or feet, or mild with pain.I am HIV positive.I am not pregnant or breastfeeding.You have a certain amount of abnormal protein in your blood or urine.I have mild or no diarrhea and am not on antidiarrheal medication.I have been treated with ixazomib or was in a study for it.I have multiple myeloma with a specific genetic change and have undergone treatment.I am able to care for myself and perform daily activities.I do not have uncontrolled heart conditions or recent heart attacks.Your heart takes too long to recover after each beat, as shown in a special heart test.Your total bilirubin level should not be higher than 1.5 times the upper limit of the normal range.I need medication to prevent blood clots.Your white blood cell count is at least 1500 per cubic millimeter.My kidneys are functioning well enough, with a creatinine clearance of at least 30 mL/min.I am not undergoing treatment for any cancer except for skin, breast, or cervical pre-cancers.Women who can have babies need to have a negative pregnancy test within 7 days before joining the study.I have stopped taking all CYP2C8 related medications for at least 7 days.Your hemoglobin level is at least 8.0 grams per deciliter.Your AST and ALT levels in your blood are not more than 3 times the upper limit of normal.Your platelet count is at least 75,000 per cubic millimeter.I am willing to give bone marrow and blood samples for research.You have a current or suspected infection of hepatitis B or C.I haven't taken strong CYP3A4 medications in the last 14 days.I have a stomach or intestine condition that affects how I absorb pills or makes it hard for me to swallow.I have not had major surgery in the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ixazomib citrate, idasanutlin, dexamethasone)
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.
Why was this clinical research created?
"The primary goal of this 28 day trial is to observe and document any adverse events that occur. These will be graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events. Additionally, researchers will keep track of the rate of complete and partial responses in order to better understand the efficacy of the treatment."
Answered by AI
Are there any participating hospitals in Canada?
"A few of the 8 locations where this study is recruiting patients are Mayo Clinic in Rochester, Minnesota, City of Hope Comprehensive Cancer Center in Duarte, California, and Wayne State University/Karmanos Cancer Institute in Detroit, Michigan."
Answered by AI
Are there any other drugs that have been trialed in a similar way to Pharmacological Study?
"Pharmacological Study was first trialed in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. So far, a total of 1719 trials have been completed with 605 ongoing clinical trials. Many of these current studies are based out of Rochester, Minnesota."
Answered by AI
What do doctors use Pharmacological Study to manage?
"Pharmacological Study is often used to treat ophthalmia, sympathetic. However, it has also been known to effectively manage conditions such as branch retinal vein occlusion, macular edema, and other issues with the eye."
Answered by AI
Are patients currently being signed up for this clinical trial?
"According to the information available on clinicaltrials.gov, this particular study is no longer recruiting patients for participation. The trial was initially posted on December 30th, 2015 but was most recently updated on June 1st, 2022. Although this trial is not currently looking for new participants, there are 1433 other studies that are still recruiting patients."
Answered by AI
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