CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
Anakinra +4 morebiological
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/NCT02492750
NCT02492750Phase 1Completed

Phase I/II Double Blind Randomized Trial of Lenalidomide/Dexamethasone/Anakinra vs. Lenalidomide/Dexamethasone/Placebo in Patients With Early Stage Multiple Myeloma and High Plasma Cell Growth Rate

Mayo Clinic·interventional·Posted Jul 9, 2015·Updated Mar 25, 2020

In Brief

A Phase 1 clinical trial evaluating Anakinra, Dexamethasone, and 3 other interventions for Indolent Plasma Cell Myeloma and 2 related conditions. Completed, enrolled 14 participants across 1 site.

Detailed Summary

This partially randomized phase I/II trial studies the side effects and best dose of anakinra when given together with lenalidomide and dexamethasone in treating patients with early stage multiple myeloma. Biological therapies, such as lenalidomide and anakinra, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, 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. It is not yet known whether lenalidomide and dexamethasone are more effective with or without anakinra in treating patients with multiple myeloma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 9, 2015
Enrollment StartApr 1, 2016
Primary CompletionJun 5, 2019
Study CompletionSep 13, 2019
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 11.0 years ago

Interventions

Anakinrabiological

Given SC

Dexamethasonedrug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Lenalidomidedrug

Given PO

Placeboother

Given SC