Trial · NCT02921893
Ixazomib Citrate, Lenalidomide, and Dexamethasone in Treating Patients With POEMS Syndrome
NCT02921893, Early phase 1, Completed, Mayo Clinic
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ixazomib Citrate, Lenalidomide, and Dexamethasone in Treating Patients With POEMS Syndrome. Trials, record NCT02921893. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02921893
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ixazomib Citrate, Lenalidomide, and Dexamethasone in Treating Patients With POEMS Syndrome
- NCT number
- NCT02921893
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 21 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Plasmacytoma, POEMS Syndrome
- Interventions
- Dexamethasone, Ixazomib Citrate, Lenalidomide, Questionnaire Administration
- First posted
- 2016-10-03
- Last updated
- 2025-02-12
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of normalization of VEGF defined as VEGF value decreasing to below upper limit of normal (86 pg/mL) | 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. |
| Secondary | Hematologic response rate | Up to 3 months | 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. |
| Secondary | Hematologic response rate | Up to 12 months | 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. |
| Secondary | Normalization of VEGF | Up to 12 months | 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. |
| Secondary | Survival time | Time from registration to death due to any cause, assessed up to 3 years | The distribution of survival time will be estimated using the method of Kaplan-Meier. |
| Secondary | Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 | Up to 3 years | 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. |
| Other | Change in peripheral neuropathy evaluated by Modified Neurological Impairment Score +7 polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes | Baseline up to 36 months | Improvement of peripheral neuropathy (Modified Neurological Impairment Score +7 polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) will be defined as decrease of \>= 2 points. Other neurologic tests including Overall Neuropathy Limitations Scale, polyneuropathy disability score, and EQ-5D-5L health questionnaire will be analyzed descriptively. |
| Other | Change in positron emission tomography-scan | 3 months up to 36 months | Improvements will be assessed by evaluating changes from baseline and will be described descriptively. |
| Other | Change in presence or absence of ascites/effusions/edema | 3 months up to 36 months | Improvements will be assessed by evaluating changes from baseline and will be described descriptively. |
| Other | Change in right ventricular systolic pressure evaluated by echocardiogram | 3 months up to 36 months | Improvements will be assessed by evaluating changes from baseline and will be described descriptively. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02921893
GET https://conductscience.org/api/trials/v1/NCT02921893/registered