RecruitingPhase 2Phase 3NCT04513639

The Relapse from MRD Negativity As Indication for Treatment (REMNANT) Study


Sponsor

Oslo University Hospital

Enrollment

176 participants

Start Date

Aug 27, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The REMNANT study will evaluate whether treating minimal residual disease (MRD) relapse after first line treatment prolongs progression free survival and overall survival for myeloma patients versus treating relapse after first line treatment at progressive disease. To establish a homogenous group of MRD negative patients after first line treatment including autologous stem cell transplantation, patients are enrolled at diagnosis and treated with Norwegian standard of care first line treatment. MRD negative patients will move on to the randomized part.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the best time to restart treatment in newly diagnosed multiple myeloma patients who achieve complete remission (no detectable cancer) after stem cell transplant, but then show early signs that the disease may be returning. **You may be eligible if...** - You have been newly diagnosed with multiple myeloma - You are between 18 and 75 years old and eligible for high-dose chemotherapy and stem cell transplant - You have achieved a deep remission (MRD negative status) after treatment - You later show signs of early disease return on sensitive testing **You may NOT be eligible if...** - You have significant other health conditions that would make participation unsafe - You cannot tolerate the study treatment regimens - You have had a prior stem cell transplant for a different condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGEarly treatment of relapse with carfilzomib, dexamethasone, daratumumab

Second line treatment will start at MRD reapperance

DRUGStandard treatment of relapse with carfilzomib, dexamethasone, daratumumab

Second line treatment will start at progressive disease


Locations(13)

Ålesund Hospital

Ålesund, Norway

Haukeland University Hospital

Bergen, Norway

Nordland Hospital Bodø

Bodø, Norway

Sykehuset Ostfold

Fredrikstad, Norway

Førde Central Hospital

Førde, Norway

Sørlandet Hospital Kristiansand

Kristiansand, Norway

Levanger Hospital

Levanger, Norway

Akershus University Hospital

Lørenskog, Norway

Oslo University Hospital

Oslo, Norway

Helse Stavanger HF

Stavanger, Norway

University Hospital North Norway

Tromsø, Norway

St. Olavs Hospital

Trondheim, Norway

The Hospital of Vestfold

Tønsberg, Norway

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04513639


Related Trials