NCT02916771

Trial of Combination of Ixazomib and Lenalidomide and Dexamethasone in Smoldering Multiple Myeloma

Phase II Trial of Combination of Ixazomib and Lenalidomide and Dexamethasone in Smoldering Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating a new drug called "ixazomib" as a possible treatment for Smoldering Multiple Myeloma.

Detailed description

This research study is a Phase II clinical trial, which tests the effectiveness of an investigational drug(s). The investigational drugs used in this research study are Ixazomib, Lenalidomide and Dexamethasone. "Investigational" means that the FDA (the U.S. Food and Drug Administration) has not approved the combination of Ixazomib, Lenalidomide and Dexamethasone as a treatment regimen for Smoldering Multiple Myeloma. The purpose of this research study is to learn whether the combination of Ixazomib, Lenalidomide, and Dexamethasone works in treating Smoldering Multiple Myeloma. Ixazomib is a drug that may kill or stop cancer cells from growing by blocking the proteasome within the cell, which is responsible for degrading or breaking down a variety of proteins. This type of drug is called a proteasome inhibitor. Lenalidomide is an immunomodulatory drug, meaning it modifies the participant immune system to help fight the participant disease. Dexamethasone is a steroid, which is usually combined with other drugs to enhance their effects to fight the participant disease. Ixazomib is approved by the FDA in combination with Lenalidomide and Dexamethasone for the treatment of Multiple Myeloma and is currently being evaluated for use in the treatment of several types of cancers. Both Lenalidomide and Dexamethasone have been previously approved by the FDA for the treatment of Multiple Myeloma, as well as several other cancers.

Conditions

• Smoldering Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Ixazomib	Oral, proteasome inhibitor
DRUG	Lenalidomide	Oral, immunomodulatory agent
DRUG	Dexamethasone	Oral, steroid

Timeline

• Start date: 2016-10-01
• Primary completion: 2025-01-08
• Completion: 2025-01-08
• First posted: 2016-09-27
• Last updated: 2025-08-11
• Results posted: 2025-03-05

Locations

1 site across 1 country: United States