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Corticosteroid
Ixazomib + Lenalidomide + Dexamethasone for POEMS Syndrome
Phase < 1
Waitlist Available
Led By Angela Dispenzieri
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female patients of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2, or 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat POEMS syndrome. Ixazomib citrate, lenalidomide, and dexamethasone may work better together to treat this disease.
Who is the study for?
This trial is for patients with POEMS syndrome, a condition involving nerve damage, organ enlargement, and abnormal blood protein levels. Participants must have high plasma VEGF levels, evidence of a plasma cell clone, adequate liver function (ALT/AST <= 3x ULN), creatinine clearance >= 30 mL/min/1.73 m^2, and be able to take aspirin daily for blood clot prevention. Women must test negative for pregnancy and use birth control; men also need to agree to contraception. They should not have had recent chemotherapy or radiation therapy.Check my eligibility
What is being tested?
The study tests the effectiveness of ixazomib citrate combined with lenalidomide and dexamethasone in treating POEMS syndrome. Ixazomib may block enzymes needed by cancer cells to grow; lenalidomide can kill or stop these cells from dividing; dexamethasone lowers immune response aiding other cancer treatments.See study design
What are the potential side effects?
Possible side effects include digestive issues due to oral drug absorption problems, increased risk of infections including hepatitis B or C reactivation if previously infected, potential heart complications like myocardial infarction within the last six months before starting treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am using two birth control methods or am not having sex to avoid pregnancy during and after the study.
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I can care for myself but may not be able to do heavy physical work.
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I have POEMS syndrome that needs treatment, whether or not I've been treated before.
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I can safely take aspirin or other blood thinners daily.
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 normalization of VEGF defined as VEGF value decreasing to below upper limit of normal (86 pg/mL)
Secondary outcome measures
Hematologic response rate
Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Normalization of VEGF
+1 moreOther outcome measures
Change in bone biomarkers procollagen type I N propeptide and collagen type 1 C-telopeptide
Change in diffusion capacity of the lung for carbon monoxide
Endocrine System Diseases
+11 moreSide 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
Group I: Group II (ixazomib citrate, lenalidomide, dexamethasone)Experimental Treatment4 Interventions
Patients receive ixazomib citrate PO, lenalidomide PO QD, and dexamethasone PO as in Group I. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Group I (ixazomib citrate, lenalidomide, dexamethasone, ASCT)Experimental Treatment4 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. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo standard of care ASCT after completing 3 cycles of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Ixazomib Citrate
2012
Completed Phase 2
~200
Lenalidomide
2005
Completed Phase 3
~1480
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,208 Previous Clinical Trials
3,767,029 Total Patients Enrolled
1 Trials studying POEMS Syndrome
240 Patients Enrolled for POEMS Syndrome
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,860 Total Patients Enrolled
Angela DispenzieriPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
149 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function, measured by creatinine clearance, is adequate.I am using two birth control methods or am not having sex to avoid pregnancy during and after the study.I haven't taken strong CYP3A inducers or St. John's wort in the last 14 days.My total bilirubin level is 2.0 mg/dL or less, or it's high due to Gilbert's disease.I am newly diagnosed or have had chemotherapy for POEMS with some exceptions.I haven't taken certain cancer drugs or high dose steroids in the last 28 days.I have a stomach or intestine condition that affects how I absorb pills.I agree to use contraception during and for 120 days after the study.I need to take high doses of corticosteroids.My condition did not improve after treatment with proteasome inhibitors or immunomodulatory drugs.I am immunocompromised or HIV positive and on antiretroviral therapy.I have not had radiotherapy in the last 14 days.I am not pregnant, nursing, or if capable of childbearing, I agree to use contraception.I still have side effects from my last chemotherapy.I can care for myself but may not be able to do heavy physical work.I haven't had another cancer within the last 3 years, with some exceptions.I have POEMS syndrome that needs treatment, whether or not I've been treated before.I have had a heart attack in the last 6 months or have heart failure needing ongoing treatment.I have not had major surgery in the last 14 days.My liver function tests are within normal limits.My white blood cell count is healthy.I do not have an ongoing infection or active hepatitis B or C.I have other serious illnesses besides my cancer.I can safely take aspirin or other blood thinners daily.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open spots for this investigation?
"This clinical trial has concluded patient recruitment, with the first posting of 10/31/2016 and last edit being 11/9/2022. There are numerous alternatives available: 1,418 studies actively recruiting patients suffering from plasmacytoma and 715 trials involving Ixazomib Citrate that are open to participants."
Answered by AI
What is the total sample size participating in this research?
"At this time, enrollment for this trial has ceased. It was first posted on October 31st 2016 and last modified on November 9th 2022. If you're looking to join another study, there are 1418 trials actively enrolling patients who have plasmacytoma and 715 studies admitting participants into Ixazomib Citrate therapy research."
Answered by AI
Is Ixazomib Citrate currently being tested in any other clinical trials?
"At present, 715 trials are underway exploring the efficacy of Ixazomib Citrate. Of those active investigations, 167 have reached Phase 3. Mishawaka in Indiana is home to a majority of these studies; however, there are 26046 research sites globally conducting this trial."
Answered by AI
For which medical conditions is Ixazomib Citrate prescribed?
"Ixazomib Citrate is an effective therapeutic option for treating ophthalmia, sympathetic conditions, patients who have undergone two or more systemic chemotherapy regimens, and branch retinal vein occlusion."
Answered by AI
Who else is applying?
What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
How is care coordinated between the Mayo Clinic and Birmingham VA Medical Center and our affiliate hospital, University of Alabama Birmingham?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
My husband Derek Bracy was diagnosed and has been treated for CIDP since 2017. However, in August 2023 he was admitted to the hospital for an exacerbation of symptoms. The plan was to receive a five day course of IVIG. In short, the Internal Medicine team consulted Hem Onc, and Endocrine because many of Derek's labs were abnormal. He has since been diagnosed with POEMS syndrome and I am interested in stopping the progression of the disease.
PatientReceived 2+ prior treatments
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