CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
Nivolumab +2 moredrug
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/NCT02903381
NCT02903381Phase 2Completed

Phase II Trial of the PD-1 Antibody Nivolumab in Combination With Lenalidomide and Low Dose Dexamethasone in Patients With High-Risk Smoldering Multiple Myeloma

Dana-Farber Cancer Institute·interventional·Posted Sep 16, 2016·Updated Jun 13, 2023

In Brief

A Phase 2 clinical trial evaluating Nivolumab, Lenalidomide, and 1 other intervention for Smoldering Multiple Myeloma. Completed, enrolled 8 participants across 1 site.

Detailed Summary

This research study is evaluating a new drug called "nivolumab" as a possible treatment for smoldering multiple myeloma in order to prevent or postpone development of active multiple myeloma. \- Patients with smoldering multiple myeloma do not have symptoms but are at risk for progressing to active multiple myeloma. Multiple myeloma is a cancer of the plasma cell, which is an important part of the immune system. Patients with active multiple myeloma generally require treatment.

Study Details

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

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 16, 2016
Enrollment StartOct 20, 2016
Primary CompletionJun 28, 2018
Study CompletionSep 16, 2021
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.8 years ago

Interventions

Nivolumabdrug

Intravenous, predetermined dosage, Days 1 and 15 during cycles 1-12 and

Lenalidomidedrug

Oral, predetermined dosage, Days 1-21 of cycle 1-12

Dexamethasonedrug

Oral, Days 1, 8, 15 of cycle 1-6