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Corticosteroid
Ixazomib + Pomalidomide + Dexamethasone for Multiple Myeloma
Phase 1 & 2
Recruiting
Research Sponsored by Paul Richardson, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Previously diagnosed with MM based on standard IMWG criteria and currently requires treatment
Patients with relapsed and relapsed refractory myeloma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from first dose of study drug to death or date last known alive, whichever came first, assessed up to 60 months
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat multiple myeloma in patients who have not responded to other treatments.
Who is the study for?
This trial is for adults with Multiple Myeloma that has come back or didn't respond to treatment. They must have tried at least two therapies, be in decent physical shape (able to perform daily activities), and not have had certain other treatments recently. Women who can get pregnant must follow specific pregnancy testing rules.Check my eligibility
What is being tested?
The study tests a combination of three drugs: Ixazomib, Pomalidomide, and Dexamethasone given twice weekly for patients whose Multiple Myeloma has relapsed or is refractory. It's designed to see how safe this mix is and how well it works.See study design
What are the potential side effects?
Possible side effects include digestive issues, blood clots, low blood counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or pain, allergic reactions, and others depending on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple myeloma and need treatment now.
Select...
My myeloma has returned after treatment.
Select...
I can care for myself but may not be able to do active work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from first dose of study drug to death or date last known alive, whichever came first, assessed up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from first dose of study drug to death or date last known alive, whichever came first, assessed up to 60 months
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 dose limiting toxicity
Overall Response Rate
Secondary outcome measures
Duration of Response
Overall Survival
Progression Free Survival
+1 moreSide effects data
From 2021 Phase 4 trial • 45 Patients • NCT0341637426%
Diarrhoea
23%
White blood cell count decreased
21%
Platelet count decreased
15%
Neutrophil count decreased
13%
Pneumonia
8%
Rash
8%
Anaemia
8%
Constipation
8%
Malaise
8%
Pyrexia
5%
Acute kidney injury
5%
Nasopharyngitis
5%
Influenza
3%
Pneumonia bacterial
3%
Tumour lysis syndrome
3%
Febrile neutropenia
3%
Prinzmetal angina
3%
Bile duct stone
3%
Gastroenteritis
3%
Interstitial lung disease
3%
Taste disorder
3%
Enterocolitis
3%
Duodenal ulcer
100%
80%
60%
40%
20%
0%
Study treatment Arm
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy
[Overall]; Combination Therapy + Ixazomib Therapy
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: ixazomib plus pomalidomide and dexamethasoneExperimental Treatment3 Interventions
The study drugs will be administered within a 21-day cycle
Phase I will follow a standard "3 +3" dose escalation design: Starting with the first cohort, 3 to 6 patients will be treated at this and each subsequent dose level.
The Phase II portion of the study will be a single-arm open-label enrollment with dosing based on the MTD determination in the Phase I portion of the study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Ixazomib
2017
Completed Phase 4
~3370
Pomalidomide
2011
Completed Phase 2
~1020
Find a Location
Who is running the clinical trial?
Paul Richardson, MDLead Sponsor
1 Previous Clinical Trials
729 Total Patients Enrolled
1 Trials studying Multiple Myeloma
729 Patients Enrolled for Multiple Myeloma
Paul G. Richardson, MDLead Sponsor
1 Previous Clinical Trials
729 Total Patients Enrolled
1 Trials studying Multiple Myeloma
729 Patients Enrolled for Multiple Myeloma
TakedaIndustry Sponsor
1,202 Previous Clinical Trials
4,178,205 Total Patients Enrolled
50 Trials studying Multiple Myeloma
18,172 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any health or personal issues that would make it hard for me to follow the study's requirements.I have a GI condition or had surgery that may affect medication absorption.I am not pregnant or breastfeeding.I haven't had certain treatments recently.I have not had major surgery or radiation therapy in the last 14 days.I have heart problems that are not well-managed.I take more than the specified amount of corticosteroids daily.I am experiencing hair loss of any severity.I am not currently infected with HIV, HBV, or HCV.I haven't had or been treated for another cancer in the last 3 years.I've had at least two treatments for my condition or one if it included specific drugs and my disease got worse within 60 days after treatment.I haven't taken any systemic treatments recently.I agree to follow the pregnancy testing schedule as required.I have been diagnosed with POEMS syndrome.I haven't needed antibiotics for an infection in the last 14 days.I have been diagnosed with multiple myeloma and need treatment now.My myeloma has returned after treatment.I have amyloidosis or plasma cell leukemia with symptoms.I cannot tolerate blood clot prevention treatments.I have been treated with ixazomib or my condition did not improve with pomalidomide.My nerve damage symptoms are mild or moderate without pain.I can care for myself but may not be able to do active work.I still have side effects from my last chemotherapy.Your disease can be accurately measured using specific medical guidelines from 2014.You have had a severe allergic reaction to similar medications in the past.Your recent lab test results need to be within certain ranges.My cancer has spread to my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: ixazomib plus pomalidomide and 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the aims of this research project?
"The primary metric that will be used to gauge the success of this clinical trial over the course of 21 days is Overall Response Rate. Additionally, Secondary outcomes like Progression Free Survival, Duration of Response, and Overall Survival will also be estimated using Kaplan-Meier."
Answered by AI
Why is Ixazomib often prescribed?
"Ixazomib is an effective treatment for ophthalmia, sympathetic eye disorder, and branch retinal vein occlusion."
Answered by AI
How many participants are being enrolled in this trial?
"That is correct. The clinical trial is currently recruiting patients, with the most recent update on recruitment happening on 4/13/2022. The study was originally posted on 9/18/2019 and 61 patients are needed from 1 location."
Answered by AI
Are researchers actively looking for more participants for this trial?
"That is correct, the study detailed on clinicaltrials.gov appears to be ongoing and currently looking for patients. The listing indicates that the trial began on September 18th, 2019 and was last updated April 13th, 2022. At this time, 61 people are needed at a single location."
Answered by AI
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