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A Phase II Trial If Nivolumab, Lenalidomide and Dexamethasone in High Risk Smoldering Myeloma

NCT02903381 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-06-13

Study results available
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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.

Conditions

  • Smoldering Multiple Myeloma

Interventions

DRUG

Nivolumab

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

DRUG

Lenalidomide

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

DRUG

Dexamethasone

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

Sponsors & Collaborators

Principal Investigators

  • Irene M. Ghobrial, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-20
Primary Completion
2018-06-28
Completion
2021-09-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02903381 on ClinicalTrials.gov