The Relapse from MRD Negativity As Indication for Treatment (REMNANT) Study
1 other identifier
interventional
176
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started Aug 2020
Longer than P75 for phase_2 multiple-myeloma
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2020
CompletedFirst Posted
Study publicly available on registry
August 14, 2020
CompletedStudy Start
First participant enrolled
August 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2032
March 20, 2025
March 1, 2025
10.8 years
August 12, 2020
March 17, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Progression Free Survival (PFS)
Median PFS of Arm A (MRD guided) vs Arm B (PD guided) defined as the time from randomization to disease progression or death due to any cause following 2.L treatment.
10 years
Overall survival (OS)
Median OS of Arm A vs Arm B (MRD guided) defined as the time from randomization to death of any cause following 2.L treatment.
11 years
Minimal residual disease negativity after first line treatment
The number of participants who achieve MRD negativity measured by Euroflow NGF at 30-45 after consolidation therapy has ended
30-45 days post consolidation
Secondary Outcomes (3)
Time-to-next treatment
10 years
Minimal residual disease negativity during second line treatment
6 months after starting second line treatment
Health-related quality of life (HRQOL)
10 years
Study Arms (2)
Arm A
EXPERIMENTALPatients will be followed with MRD assessment every 4 month and start 2.L treatment at loss of MRD negative complete response.
Arm B
ACTIVE COMPARATORPatients will be followed up by standard criteria and start 2.L treatment at progressive disease.
Interventions
Second line treatment will start at MRD reapperance
Second line treatment will start at progressive disease
Eligibility Criteria
You may qualify if:
- Patient with newly diagnosed multiple myeloma (IMWG criteria) eligible for high-dose therapy and ASCT.
- Patient must be \>18 and \< 75 years of age at the time of signing the informed consent
- Must have measurable disease as defined by the International Myeloma Working Group; serum monoclonal paraprotein (M-protein) level \> 10 g/L or light chain multiple myeloma without measurable disease in the serum; serum immunoglobulin FLC \> 100 mg/L and abnormal serum immunoglobulin kappa lambda FLC ratio.
- Voluntary written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. ECOG 3 can be enrolled if caused by myeloma.
- Patient must be willing and able to adhere to the study protocol visit schedule and other protocol requirements.
- FCBP and male subject who are sexually active with FCBP must agree to use highly effective concomitant methods of contraceptive during the study and for at least 28 days following the last study drug dose. Male subjects must use contraception and refrain from donating sperm for at least 28 days after the last dose of lenalidomide according to Pregnancy Prevention Plan (Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information).
- Has received 1.L treatment in part 1 of the study.
- ECOG performance status score 0, 1 or 2
You may not qualify if:
- Received more than one cycle of induction treatment for multiple myeloma.
- Patient with ongoing or active systemic infection, active hepatitis B or C virus infection or known human immunodeficiency virus (HIV) positive
- Concurrent medical or psychiatric condition or disease that is incompatible to HDM and ASCT or that will likely result in reduced study compliance and reduce ability to follow study procedures, or that in the opinion of the investigator, would constitute a hazard for participating in this study.
- No active malignancy with a lower life expectancy than myeloma
- Female patient who have a positive serum pregnancy test during the screening period.
- Female patient who is lactating during the screening period but are not willing to stop lactating prior to the first treatment cycle starts.
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- No active malignancy with a lower life expectancy than myeloma
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- St. Olavs Hospitalcollaborator
- Haukeland University Hospitalcollaborator
- University Hospital of North Norwaycollaborator
- University Hospital, Akershuscollaborator
- Helse Stavanger HFcollaborator
- Førde Central Hospitalcollaborator
- Sorlandet Hospital HFcollaborator
- Nordlandssykehuset HFcollaborator
- The Hospital of Vestfoldcollaborator
- Helse Nord-Trøndelag HFcollaborator
- Alesund Hospitalcollaborator
- Sykehuset Ostfoldcollaborator
Study Sites (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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fredrik Schjesvold, MD, PhD
Oslo University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Oslo Myeloma Center
Study Record Dates
First Submitted
August 12, 2020
First Posted
August 14, 2020
Study Start
August 27, 2020
Primary Completion (Estimated)
June 1, 2031
Study Completion (Estimated)
June 1, 2032
Last Updated
March 20, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share