CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
Elotuzumab +6 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/NCT01729091
NCT01729091Phase 2Completed

Phase II Study of Umbilical Cord Blood-Derived Natural Killer Cells in Conjunction With Elotuzumab, Lenalidomide and High Dose Melphalan Followed by Autologous Stem Cell Transplant for Patients With Multiple Myeloma

M.D. Anderson Cancer Center·interventional·Posted Nov 20, 2012·Updated May 9, 2025

In Brief

A Phase 2 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation, Elotuzumab, and 5 other interventions for Plasma Cell Leukemia and Plasma Cell Myeloma. Completed, enrolled 72 participants across 1 site.

Detailed Summary

This phase II trial studies the side effects and best dose of umbilical cord blood-derived natural killer cells when given together with elotuzumab, lenalidomide, and high dose melphalan before autologous stem cell transplant and to see how well they work in treating patients with multiple myeloma. Before transplant, stem cells are taken from patients and stored. Immunotherapy with monoclonal antibodies, such as elotuzumab, may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide and melphalan, may work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving natural killer cells from donor umbilical cord blood before transplant may also kill myeloma cells that remain in the body after the last chemotherapy treatment. After treatment, stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

Study Details

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

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 20, 2012
Enrollment StartJun 10, 2013
Primary CompletionJun 25, 2024
TodayJul 2, 2026
Enrollment to primary: 11.0 yearsPosted 13.6 years ago

Interventions

Autologous Hematopoietic Stem Cell Transplantationprocedure

Undergo autologous stem cell transplant

Elotuzumabbiological

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Lenalidomidedrug

Given PO

Melphalandrug

Given IV

Natural Killer Cell Therapybiological

Given IV

Umbilical Cord Blood-Derived Lymphocyte Therapybiological

Given IV