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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02921893
Date of registration: 26/09/2016
Prospective Registration: Yes
Primary sponsor: Mayo Clinic
Public title: Ixazomib Citrate, Lenalidomide, and Dexamethasone in Treating Patients With POEMS Syndrome
Scientific title: Ixazomib, Lenalidomide, and Dexamethasone for Patients With POEMS Syndrome
Date of first enrolment: October 31, 2016
Target sample size: 34
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02921893
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Clinical Trials Referral Office
Address: 
Telephone: 855-776-0015
Email: mayocliniccancerstudies@mayo.edu
Affiliation: 
Name:     Angela Dispenzieri
Address: 
Telephone:
Email:
Affiliation:  Mayo Clinic
Key inclusion & exclusion criteria

Inclusion Criteria:

- POEMS syndrome requiring therapy, previously treated or untreated

- Plasma vascular endothelial growth factor (VEGF) > 2 x upper limit of normal (ULN)

- Presence of a plasma cell clone (any of the following):

- Monoclonal protein in the serum or urine

- Measurable light chains by free light chain assay

- Measurable plasmacytoma

- Monoclonal plasma cells in bone marrow

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2, or 3

- Absolute neutrophil count (ANC) >= 1000/uL

- Platelet count (PLT) >= 75,000/uL

- Total bilirubin =< 2.0 mg/dL unless due to known Gilbert's disease

- NOTE: If total bilirubin is > 2 mg/dL, a direct bilirubin should be performed and
must be < 1.5 mg/dL for Gilbert's to be diagnosed

- Alanine aminotransferase (ALT/serum glutamic pyruvic transaminase [SGPT]) and
aspartate aminotransferase (AST, serum glutamic oxaloacetic transaminase [SGOT]) =< 3
x upper limit of normal (ULN)

- Creatinine clearance >= 30 mL/min/1.73 m^2 (as determined by Cockcroft-Gault equation)

- Negative serum pregnancy test done =< 7 days prior to registration, for women of
childbearing potential only

- NOTE: Females of reproductive potential must adhere to the scheduled pregnancy
testing as required in the Revlimid REMS program

- Birth control

- 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

- NOTE: Patients of childbearing potential are those who have not been
surgically sterilized or have not been free from menses for > 1 year

- Male patients must agree to use an adequate method of contraception starting with
the first dose of study therapy through 120 days after the last dose of study
therapy

- NOTE: Abstinence is acceptable (for either males or females) if this is the
established and preferred method of contraception for the subject

- Willing to adhere to the guidelines of the Revlimid REMS (formerly known as RevAssist)
program

- NOTE: The counseling must be documented

- Provide written informed consent

- Willing to return to enrolling institution for follow-up (during the active monitoring
phase of the study)

- Note: During the active monitoring phase of a study (i.e., active treatment and
observation), participants must be willing to return to the consenting
institution for follow-up

- No contraindication to be on a minimum of 81 mg aspirin a day (or other anticoagulant
therapy as prescribed) for thromboembolism prophylaxis

- Willing to provide mandatory blood and bone marrow samples for research purposes

- Ability to complete questionnaire(s) by themselves or with assistance

Exclusion Criteria:

- Recent prior chemotherapy:

- Newly diagnosed patients (regardless of group); any prior chemotherapy for POEMS
with the following exceptions:

- Prior immunomodulators like azathioprine, cyclosporin, and/or
corticosteroids are not exclusionary therapies if used for prior diagnosis
of chronic inflammatory demyelinating polyneuropathy

- Prior chemotherapy directed at a "myeloproliferative neoplasm" like
hydroxyurea is not exclusionary

- Previously treated patients (group 2)

- Alkylators (e.g. melphalan, cyclophosphamide) =< 28 days prior to
registration

- Anthracyclines =< 28 days prior to registration

- High dose corticosteroids, immune modulatory drugs (thalidomide or
lenalidomide), or proteosome inhibitors (e.g. ixazomib or bortezomib) =< 28
days prior to registration

- Requirement for concomitant high dose corticosteroids

- EXCEPTION: Patients may be on chronic steroids (maximum dose 20 mg/day prednisone
equivalent) if they are being given for adrenal insufficiency, rheumatoid
arthritis, etc

- Receiving any other investigational agent, which would be considered as a treatment
for the primary neoplasm

- Participation in other clinical trials, including those with other investigational
agents not included in this trial, =< 30 days prior to registration and throughout the
duration of this trial

- Prior refractoriness to proteasome inhibitor or immunomodulatory drugs (IMiD)

- Any of the following because this study involves an agent that has known genotoxic,
mutagenic and teratogenic effects:

- Pregnant women

- Nursing women

- Men or women of childbearing potential who are unwilling to employ adequate
contraception

- Other active malignancy =< 3 years prior to registration

- EXCEPTIONS: Non-melanotic skin cancer, ductal carcinoma in-situ, or
carcinoma-in-situ of the cervix

- NOTE: If there is a history of prior malignancy, they must not be receiving other
specific treatment for their cancer

- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study or
interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens, e.g. uncontrolled infection (infection requiring systemic
antibiotic therapy or other serious infection =< 14 days prior to registration); or
uncompensated heart or lung disease

- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV)
positive and currently receiving antiretroviral therapy

- Systemic treatment with strong CYP3A inducers (rifampin, rifapentine, rifabutin,
carbamazepine, phenytoin, phenobarbital), or use of St. John's wort =< 14 days prior
to registration

- History of myocardial infarction =< 6 months prior to registration, or congestive
heart failure requiring use of ongoing maintenance therapy for life-threatening
ventricular arrhythmias

- Radiotherapy =< 14 days prior to registration

- Major surgery =< 14 days prior to registration

- Failure to fully recover (i.e. =< grade 1 adverse even



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Plasmacytoma
POEMS Syndrome
Intervention(s)
Drug: Dexamethasone
Drug: Ixazomib Citrate
Drug: Lenalidomide
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration
Primary Outcome(s)
Rate of normalization of VEGF defined as VEGF value decreasing to below upper limit of normal (86 pg/mL) [Time Frame: Up to 3 months]
Secondary Outcome(s)
Hematologic response rate [Time Frame: Up to 12 months]
Hematologic response rate [Time Frame: Up to 3 months]
Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [Time Frame: Up to 3 years]
Normalization of VEGF [Time Frame: Up to 12 months]
Survival time [Time Frame: Time from registration to death due to any cause, assessed up to 3 years]
Secondary ID(s)
MC1682
NCI-2016-01426
P30CA015083
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Cancer Institute (NCI)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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