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Corticosteroid
Ixazomib + Pomalidomide + Dexamethasone for Multiple Myeloma
Phase 1 & 2
Waitlist Available
Led By Amrita Krishnan
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the initial treatment to 24 months
Awards & highlights
Study Summary
This trial is testing ixazomib given with pomalidomide and dexamethasone to see if it is effective in treating patients with relapsed or relapsed/refractory multiple myeloma.
Who is the study for?
This trial is for patients with multiple myeloma who have tried at least one but no more than five previous treatments. They must not be pregnant or breastfeeding, should not have severe infections or other serious health issues that could interfere with the study, and cannot have had certain recent medical procedures. Participants need to agree to birth control measures and join a drug safety program.Check my eligibility
What is being tested?
The trial is testing the combination of ixazomib (which interferes with protein breakdown in cells), pomalidomide (which modifies the immune system), and dexamethasone (a steroid) to see if they are effective and safe for treating relapsed or refractory multiple myeloma. It's also determining the best dose of ixazomib when used with these drugs.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system changes such as fatigue, digestive issues, blood disorders, increased risk of infection, potential organ inflammation due to immune response, nerve damage symptoms like numbness or tingling in extremities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the initial treatment to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the initial treatment to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) of MLN9708 (Phase I)
Number of Patients With Dose-Limiting Toxicities (Phase I)
Overall Response Rate at the Recommended Phase II Dose (RP2D)
Secondary outcome measures
Clinical Benefit Response Rate at the Recommended Phase II Dose (RP2D)
Duration of Response at the Recommended Phase II Dose (RP2D)
One-Year Overall Survival at the Recommended Phase II Dose (RP2D)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Treatment (4mg MLN9708)Experimental Treatment3 Interventions
Patients receive 4mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Treatment (3mg MLN9708)Experimental Treatment3 Interventions
Patients receive 3mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pomalidomide
2011
Completed Phase 3
~1110
ixazomib citrate
2014
Completed Phase 2
~40
dexamethasone
1995
Completed Phase 3
~9520
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
568 Previous Clinical Trials
1,924,628 Total Patients Enrolled
37 Trials studying Multiple Myeloma
3,427 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,680 Previous Clinical Trials
40,928,487 Total Patients Enrolled
584 Trials studying Multiple Myeloma
189,288 Patients Enrolled for Multiple Myeloma
Amrita KrishnanPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
21 Total Patients Enrolled
1 Trials studying Multiple Myeloma
18 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a high level of M protein in your blood.You have not fully recovered from the side effects of previous chemotherapy.You have taken a combination of medications that included pomalidomide, except for a combination of pomalidomide and dexamethasone.You have received radiation treatment within 14 days before joining the study. If the treatment area is small, a 7-day interval is needed before taking the MLN9708 drug.You have cancer that has spread to your brain or spinal cord.You have severe nerve problems in your arms or legs during the screening period.Patients must have disease that can be measured.You have an ongoing serious infection, hepatitis B or C, or HIV.You have had another type of cancer within the past 2 years, except for nonmelanoma skin cancer or carcinoma in situ that has been completely removed.Your kidneys are working well enough to clear out waste from your body.You are able to perform daily activities without any difficulty (ECOG performance status 0, 1, or 2).Your absolute neutrophil count is at least 1,000 per cubic millimeter.You are not able or willing to take medication to prevent blood clots.You have been diagnosed with multiple myeloma that has come back after treatment, and you have received at least one but no more than five previous treatment regimens.You have more than 200 milligrams of M protein in your urine in a 24-hour period.Your blood test shows a high level of a specific protein called serum free light chain, and the ratio of different types of this protein is abnormal.You have a stomach or intestine condition that could make it hard for your body to absorb or tolerate the study drugs MLN9708 or pomalidomide.You have not responded to treatment with pomalidomide, either alone or with dexamethasone, and your disease has progressed within 60 days of taking this medication.You have taken specific medications for your condition and they haven't worked according to specific guidelines.You have taken certain medications within 14 days before starting the trial that may interact with the study drug MLN9708.You have uncontrolled heart problems or have had a heart attack in the past 6 months.Your blood platelet count needs to be at least 75,000 per microliter if most of your bone marrow cells are not plasma cells, or at least 50,000 per microliter if most of your bone marrow cells are plasma cells. You can't have received a platelet transfusion within 3 days of the last platelet count check to be eligible.The amount of bilirubin in your blood is within a certain range.Your levels of ALT and AST in your blood should be less than 3 times the upper limit of normal.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (4mg MLN9708)
- Group 2: Treatment (3mg MLN9708)
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 there openings for this clinical experiment available at present?
"This clinical trial is not currently seeking patients. It was initially published on June 30th, 2014 and most recently edited on March 28th 2022. However, there are 807 active trials recruiting participants with multiple myeloma and 591 studies searching for candidates to take part in a pomalidomide-based study."
Answered by AI
What ailments is pomalidomide used to alleviate?
"Pomalidomide has been observed to be effective in the treatment of ophthalmia, sympathetic eye disorder, and branch retinal vein occlusion."
Answered by AI
Has any research been conducted to explore the impact of pomalidomide on health?
"Pomalidomide was initially tested in 2002 at the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba and has since accumulated 1,932 completed clinical trials. Currently, 591 studies are actively recruiting patients with a large number of these based in Atlanta, Georgia."
Answered by AI
How many health care centers are currently conducting this investigation in the city?
"This research is enrolling patients at places such as Emory University/Winship Cancer Institute in Atlanta, Georgia; Mayo Clinic in Rochester, Minnesota; and Sarah Cannon Research Institute (SCRI) in Scottsdale, Arizona. There are 5 other sites involved too."
Answered by AI
How many participants are currently enrolled in this research endeavor?
"The trial is no longer actively recruiting participants, as it was last modified on the 28th of March 2022. If you are exploring other options, there are currently 807 trials searching for patients with multiple myeloma and 591 studies utilizing pomalidomide that need volunteers."
Answered by AI
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