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

Sponsor
Oslo University Hospital
Study ID
NCT04513639
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 27, 2020
Status verified
Mar 2025
Primary completion
Jun 1, 2031
Completion
Jun 1, 2032

Study Design

Enrollment
176 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Patients will be followed with MRD assessment every 4 month and start 2.L treatment at loss of MRD negative complete response.
  • Active Comparator: Arm B
    Patients will be followed up by standard criteria and start 2.L treatment at progressive disease.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 10 years ]

Central Contacts

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