CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 2 enrolled
Drug / intervention
Daratumumab Injectiondrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04396496
NCT04396496Phase 2Completed
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A Phase II Trial for the Treatment of POEMS Syndrome With Daratumumab

University of Arkansas·interventional·Posted May 20, 2020·Updated Nov 13, 2023

In Brief

A Phase 2 clinical trial evaluating Daratumumab Injection for POEMS Syndrome. Completed, enrolled 2 participants across 1 site.

Detailed Summary

This trial investigates the use of Daratumumab (DARA), an antibody directed at the human cluster of differentiation 38 (CD38) molecule, for the treatment of patients with Polyneuropathy, Organomegaly, Endocrinopathy, m Protein Component, Skin Changes (POEMS) syndrome. This trial will enroll ten subjects, who will complete 12 four-week cycles of DARA, in combination with the immunomodulatory drug (IMiD) lenalidomide. Objectives of this study include improvement in neuropathy and performance status, as well as improvement in laboratory values and survival.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPOEMS Syndrome
CountriesUnited States
CollaboratorsJanssen Scientific Affairs, LLC

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 20, 2020
Enrollment StartSep 22, 2020
Primary CompletionAug 29, 2023
Study CompletionOct 16, 2023
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.1 years ago

Interventions

Daratumumab Injectiondrug

DARA is a human monoclonal antibody that specifically recognizes the CD38 molecule that is expressed at a high level in a variety of hematological malignancies, including myeloma cells. DARA injection will be given with oral lenalidomide for up to 12 four week cycles.