Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02916771
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Active, not recruiting
Phase Phase 2
Start date October 2016
Completion date April 8, 2025

See also
  Status Clinical Trial Phase
Completed NCT01222286 - Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma Phase 2
Withdrawn NCT00503763 - Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma Phase 2
Completed NCT01955395 - Genomic and Psychosocial Effects of the 3RP on Patients With MGUS and Smoldering Multiple Myeloma N/A
Completed NCT01237054 - Imaging in MGUS, SMM and MM Phase 2
Completed NCT02903381 - A Phase II Trial If Nivolumab, Lenalidomide and Dexamethasone in High Risk Smoldering Myeloma Phase 2
Active, not recruiting NCT03301220 - A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma Phase 3
Active, not recruiting NCT03236428 - Phase II Study of the CD38 Antibody Daratumumab in Patients With High-Risk MGUS and Low-Risk Smoldering Multiple Myeloma Phase 2
Completed NCT01718899 - Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma Phase 1
Completed NCT00112827 - Melphalan and Radiation Therapy Followed By Lenalidomide in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant for Stage I, Stage II, or Stage III Multiple Myeloma Phase 1/Phase 2
Completed NCT00099047 - Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma Phase 2
Terminated NCT01248455 - A Phase II Trial of Anti-KIR in Smoldering Multiple Myeloma Phase 2
Active, not recruiting NCT03289299 - Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant Phase 2
Not yet recruiting NCT06365060 - Screening for AL Amyloidosis in Smoldering Multiple Myeloma
Active, not recruiting NCT02415413 - Carfilzomib in Treatment Patients Under 65 Years With High Risk Smoldering Multiple Myeloma Phase 2
Completed NCT01302886 - Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma Phase 2
Recruiting NCT05841550 - The TG01 Study With TG01/QS-21 Vaccine in Patients With High-risk Smouldering Multiple Myeloma and Multiple Myeloma Phase 1/Phase 2
Active, not recruiting NCT02886065 - A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM Phase 1
Withdrawn NCT01571726 - Imaging Studies and the Development of Multiple Myeloma Phase 2
Terminated NCT01838369 - A Phase II Study of BI-505 in Smoldering Multiple Myeloma Phase 2
Active, not recruiting NCT04920084 - A Study of a Plant-Based Diet in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM) N/A