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

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.

Conditions

• Multiple Myeloma

Interventions

DRUG

Early treatment of relapse with carfilzomib, dexamethasone, daratumumab

Second line treatment will start at MRD reapperance

DRUG

Standard treatment of relapse with carfilzomib, dexamethasone, daratumumab

Second line treatment will start at progressive disease

Sponsors & Collaborators

• St. Olavs Hospital

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• University Hospital of North Norway

  collaborator OTHER

• University Hospital, Akershus

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• Førde Central Hospital

  collaborator OTHER

• Sorlandet Hospital HF

  collaborator OTHER_GOV

• Nordlandssykehuset HF

  collaborator OTHER

• The Hospital of Vestfold

  collaborator OTHER

• Helse Nord-Trøndelag HF

  collaborator OTHER

• Alesund Hospital

  collaborator OTHER

• Sykehuset Ostfold

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Fredrik Schjesvold, MD, PhD · Oslo University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-27

Primary Completion

2031-06-01

Completion

2032-06-01

Countries

• Norway

Study Locations