PlasmacytomaEarly Phase 1NCT02921893
Ixazomib Citrate, Lenalidomide, and Dexamethasone in Treating Patients With POEMS Syndrome
A Early Phase 1 study testing Dexamethasone, Ixazomib Citrate and Lenalidomide in people with Plasmacytoma and POEMS Syndrome, run by Mayo Clinic at 1 site in United States.
Trial summary
This phase II trial studies how well ixazomib citrate, lenalidomide, and dexamethasone work in treating patients with polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasmacytoma, POEMS Syndrome
- What is being tested?
- Dexamethasone, Ixazomib Citrate and Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2016to 13 May 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 29Show fewer
- 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 obtained =< 14 days prior to registration
- Platelet count (PLT) >= 75,000/uL obtained =< 14 days prior to registration
- Total bilirubin =< 2.0 mg/dL unless due to known Gilbert's disease obtained =< 14 days prior to registration
- 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) obtained =< 14 days prior to registration
- Creatinine clearance >= 30 mL/min/1.73 m^2 (as determined by Cockcroft-Gault equation) obtained =< 14 days prior to registration
- 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 Risk Evaluation and Mitigation Strategy (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
Who cannot join
- 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
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- 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 event [AE]) from the reversible effects of prior chemotherapy
- Known allergy to any of the study medications, their analogs, or excipients in the various formulations of any agent
- Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of the study drugs including difficulty swallowing
- Ongoing or active systemic infection or active hepatitis B or C virus infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Ixazomib, Lenalidomide, and Dexamethasone for Patients With POEMS Syndrome
This phase II trial studies how well ixazomib citrate, lenalidomide, and dexamethasone work in treating patients with polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving ixazomib citrate, lenalidomide, and dexamethasone may work better in treating patients with POEMS syndrome.
Read the detailed description
PRIMARY OBJECTIVE:
- Normalization of VEGF after 3 cycles of therapy.
SECONDARY OBJECTIVES:
- Toxicity and safety of the combination of ixazomib citrate (ixazomib), lenalidomide, and dexamethasone.
II. Hematologic response after 3 cycles of therapy. III. Hematologic response rates and/or VEGF response at 12 months. IV. Overall survival.
EXPLORATORY OBJECTIVES:
- Improvement of peripheral neuropathy (Overall Neuropathy Limitations Scale [ONLS], Modified Neurological Impairment Score for POEMS [mNIS+7POEMS], and performance score), ascites/effusions, diffusing capacity of the lungs for carbon monoxide (DLCO) after 3 cycles of therapy.
II. Improvement of peripheral neuropathy (ONLS, mNIS+7POEMS, and performance score), ascites/effusions, DLCO, and positron emission tomography (PET)-scan (if abnormal at baseline) at 12 months (both groups) and at 24 and 36 months (group 2 only).
III. Time to VEGF response, hematologic response, and clinical response. IV. Time to VEGF progression, hematologic progression, and clinical progression.
- Doses delivered will be tabulated to establish tolerance of study drugs.
CORRELATIVE RESEARCH OBJECTIVES:
- To describe changes in bone biomarkers with treatment of ixazomib, lenalidomide, and dexamethasone.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients receive ixazomib citrate orally (PO) on days 1, 8, and 15, lenalidomide PO once daily (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 autologous stem cell transplant (ASCT) after completing 3 cycles of treatment.
GROUP II: 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.
After completion of study treatment, patients are followed up every 3 months until disease progression and then every 6 months for up to 36 months.
- Conditions
- Plasmacytoma, POEMS Syndrome
- Being tested
- Dexamethasone, Ixazomib Citrate, Lenalidomide, Questionnaire Administration
- Medical subject headings
- Plasmacytoma, POEMS Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex
Given PO
Ixazomib CitrateDrug
Also called MLN-9708, MLN9708, Ninlaro
Given PO
LenalidomideDrug
Also called CC-5013, CC5013, CDC 501, Revlimid
Given PO
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (ixazomib citrate, lenalidomide, dexamethasone, ASCT) | Experimental | 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. Receives: Drug: Dexamethasone; Drug: Ixazomib Citrate; Drug: Lenalidomide; Other: Questionnaire Administration |
| Group II (ixazomib citrate, lenalidomide, dexamethasone) | Experimental | 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. Receives: Drug: Dexamethasone; Drug: Ixazomib Citrate; Drug: Lenalidomide; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of normalization of VEGF defined as VEGF value decreasing to below upper limit of normal (86 pg/mL)
In each group, the rate of normalization of VEGF by 3 months (post-3 cycles) will be examined along with the prognostic factors for patients accrued to this study. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent binomial confidence intervals for the true success proportion will be calculated.
Measured: Up to 3 months
Secondary outcomes (5)
Hematologic response rate
Hematologic response rate after 3 cycles of therapy (or 3 months after registration) will be estimated by the number of hematologic responses (partial response, very good partial response, or complete response) observed within 3 months of registration divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true hematologic response rate after 3 cycles of therapy (or 3 months after registration) will be calculated.
Measured: Up to 3 months
Hematologic response rate
Hematologic response rate after 13 cycles of therapy (or 12 months) will be evaluated. Exact binomial 95% confidence intervals for the true rates at 12 months will be calculated.
Measured: Up to 12 months
Normalization of VEGF
Normalization of VEGF after 13 cycles of therapy (or 12 months after registration) will be evaluated. Exact binomial 95% confidence intervals for the true rates at 12 months will be calculated.
Measured: Up to 12 months
Survival time
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Measured: Time from registration to death due to any cause, assessed up to 3 years
Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study start31 Oct 2016
- Primary completion21 Apr 2022
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PlasmacytomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Dispenzieri, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921893
- Sponsor's protocol ID
- MC1682
- Other IDs
- NCI-2016-01426, MC1682, 16-002976
- Status last verified
- Feb 2025
- First submitted
- 26 Sep 2016
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ixazomib, Lenalidomide, and Dexamethasone for Patients With POEMS Syndrome
- ClinicalTrials.gov ID
- NCT02921893
- Acronym / sponsor ID
- MC1682
- Conditions
- Plasmacytoma, POEMS Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 3 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well ixazomib citrate, lenalidomide, and dexamethasone work in treating patients with polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving ixazomib citrate, lenalidomide, and dexamethasone may work better in treating patients with POEMS syndrome.
Detailed description
PRIMARY OBJECTIVE:
- Normalization of VEGF after 3 cycles of therapy.
SECONDARY OBJECTIVES:
- Toxicity and safety of the combination of ixazomib citrate (ixazomib), lenalidomide, and dexamethasone.
II. Hematologic response after 3 cycles of therapy. III. Hematologic response rates and/or VEGF response at 12 months. IV. Overall survival.
EXPLORATORY OBJECTIVES:
- Improvement of peripheral neuropathy (Overall Neuropathy Limitations Scale [ONLS], Modified Neurological Impairment Score for POEMS [mNIS+7POEMS], and performance score), ascites/effusions, diffusing capacity of the lungs for carbon monoxide (DLCO) after 3 cycles of therapy.
II. Improvement of peripheral neuropathy (ONLS, mNIS+7POEMS, and performance score), ascites/effusions, DLCO, and positron emission tomography (PET)-scan (if abnormal at baseline) at 12 months (both groups) and at 24 and 36 months (group 2 only).
III. Time to VEGF response, hematologic response, and clinical response. IV. Time to VEGF progression, hematologic progression, and clinical progression.
- Doses delivered will be tabulated to establish tolerance of study drugs.
CORRELATIVE RESEARCH OBJECTIVES:
- To describe changes in bone biomarkers with treatment of ixazomib, lenalidomide, and dexamethasone.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients receive ixazomib citrate orally (PO) on days 1, 8, and 15, lenalidomide PO once daily (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 autologous stem cell transplant (ASCT) after completing 3 cycles of treatment.
GROUP II: 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.
After completion of study treatment, patients are followed up every 3 months until disease progression and then every 6 months for up to 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (ixazomib citrate, lenalidomide, dexamethasone, ASCT) | Experimental | Drug: Dexamethasone, Drug: Ixazomib Citrate, Drug: Lenalidomide, Other: Questionnaire AdministrationPatients 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. |
| Group II (ixazomib citrate, lenalidomide, dexamethasone) | Experimental | Drug: Dexamethasone, Drug: Ixazomib Citrate, Drug: Lenalidomide, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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):
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2, or 3
- Absolute neutrophil count (ANC) >= 1000/uL obtained =< 14 days prior to registration
Key exclusion criteria (30 listed)
- Recent prior chemotherapy:
- Requirement for concomitant high dose corticosteroids
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: Aacidexam, Adexone, Aknichthol Dexa, Alba-DexGiven PO | Drug | Group I (ixazomib citrate, lenalidomide, dexamethasone, ASCT), Group II (ixazomib citrate, lenalidomide, dexamethasone) |
| Ixazomib CitrateAlso: MLN-9708, MLN9708, NinlaroGiven PO | Drug | Group I (ixazomib citrate, lenalidomide, dexamethasone, ASCT), Group II (ixazomib citrate, lenalidomide, dexamethasone) |
| LenalidomideAlso: CC-5013, CC5013, CDC 501, RevlimidGiven PO | Drug | Group I (ixazomib citrate, lenalidomide, dexamethasone, ASCT), Group II (ixazomib citrate, lenalidomide, dexamethasone) |
| Questionnaire AdministrationAncillary studies | Other | Group I (ixazomib citrate, lenalidomide, dexamethasone, ASCT), Group II (ixazomib citrate, lenalidomide, dexamethasone) |
Primary outcome
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
In each group, the rate of normalization of VEGF by 3 months (post-3 cycles) will be examined along with the prognostic factors for patients accrued to this study. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent binomial confidence intervals for the true success proportion will be calculated.
5 secondary outcomes
Hematologic response rate
Time frame: Up to 3 months
Hematologic response rate
Time frame: Up to 12 months
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Dispenzieri, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexamethasone, Ixazomib Citrate and Lenalidomide in people with Plasmacytoma and POEMS Syndrome, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.