CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 5 enrolled
Drug / intervention
Lenalidomide +2 moredrug
Likely dose
Lenalidomide 10 mgfrom 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/NCT02481934
NCT02481934Phase 1Completed

Phase 1 Clinical Trial to Evaluate Security and Dose of Expanded and Activated Autologous NK Cells Infusions in Consolidation of Multiple Myeloma Patients Treatment on Second or Later Relapse.

Joaquín Martínez López, MD, PhD·interventional·Posted Jun 25, 2015·Updated Aug 20, 2021

In Brief

A Phase 1 clinical trial evaluating NKAE cells infusion, Lenalidomide, and 1 other intervention for Multiple Myeloma. Completed, enrolled 5 participants across 1 site.

Detailed Summary

The purpose of this study is to determine wether activated and expanded autologous Natural Killer cells (NKAEs) are effective in the treatment of patients with multiple myeloma on second or later relapse. NKAEs are used in combination with anti-myeloma drugs such as lenalidomide or bortezomib.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 25, 2015
Enrollment StartMar 1, 2013
Primary CompletionJul 1, 2016
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.0 years ago

Interventions

NKAE cells infusionprocedure

Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.

Lenalidomidedrug

Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.

Bortezomibdrug

Bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles.