Clinical Trials Logo

Clinical Trial Summary

This research study is studying a drug as a possible treatment for Monoclonal Gammopathy of Unknown Significance (MGUS) or Smoldering Multiple Myeloma (SMM). The drug involved in this study is: -Daratumumab


Clinical Trial Description

This research study is a Phase II clinical trial, which tests the effectiveness of an investigational drug. Preliminary experience suggests that daratumumab may prevent or postpone SMM from becoming active multiple myeloma. The purpose of this research study is to determine if the this drug may improve the rate of prevention of 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. There are currently no approved therapies for smoldering multiple myeloma or Monoclonal Gammopathy of Unknown Significance. Daratumumab is a drug that may kill or stop cancer cells from growing through a variety of mechanisms by attaching to the CD38 molecule, which is over-expressed in multiple myeloma cells. This type of drug is called a monoclonal antibody. The FDA (the U.S. Food and Drug Administration) has not approved Daratumumab for the participant specific disease but it has been approved for use in active Multiple Myeloma. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03236428
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Active, not recruiting
Phase Phase 2
Start date November 24, 2017
Completion date October 4, 2026

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Withdrawn NCT00503763 - Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma Phase 2
Active, not recruiting NCT02916771 - Trial of Combination of Ixazomib and Lenalidomide and Dexamethasone in 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
Completed NCT01718899 - Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma Phase 1
Completed NCT00099047 - Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma Phase 2
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
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
Recruiting NCT06183489 - Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma Phase 2
Recruiting NCT06383143 - Promoting Diagnosis and Management of AL in Italy (ProDigALIty)
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