Clinical Trials Logo

Clinical Trial Summary

The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).


Clinical Trial Description

This study consists of 3 phases: Screening Phase (up to 35 days), an Active Monitoring Phase or a Treatment Phase of 39 cycles or 36 months (whichever occurs first), and a Follow-up Phase which will continue until death, lost to follow-up, consent withdrawal, or study end (approximately 8 years after the first participant is randomized), whichever occurs first. Active monitoring cycles and treatment cycles are 4 weeks in length. For all participants, disease evaluations will be performed every 12 weeks until confirmed progressive disease (PD). After PD, survival is to be followed at least every 6 months, until the end of the study. Participants will undergo tumor assessments, pharmacokinetics, biomarkers and safety evaluations (adverse events, laboratory tests, vital sign measurements, physical examinations, Eastern Cooperative Oncology Group [ECOG] performance status) over the time. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03301220
Study type Interventional
Source Janssen Research & Development, LLC
Contact
Status Active, not recruiting
Phase Phase 3
Start date November 7, 2017
Completion date July 11, 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Withdrawn NCT00503763 - Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma Phase 2
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 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
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
Enrolling by invitation NCT03815279 - A Nationwide Phase 2 Trial of Patients With Smoldering and Active Multiple Myeloma (MM) Phase 2