Actively Recruiting
The Relapse from MRD Negativity As Indication for Treatment (REMNANT) Study
Led by Oslo University Hospital · Updated on 2025-03-20
176
Participants Needed
13
Research Sites
613 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
S
St. Olavs Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Relapse from MRD Negativity As Indication for Treatment (REMNANT) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed multiple myeloma patients eligible for high-dose therapy and autologous stem cell transplantation
- Aged over 18 and under 75 years at the time of consent
- Measurable disease with serum monoclonal protein level greater than 10 g/L or abnormal serum immunoglobulin free light chain ratio
- Voluntary written informed consent given
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; ECOG 3 allowed if caused by myeloma
- Willing and able to comply with the study visit schedule and protocol requirements
- Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to inclusion
- Female patients of childbearing potential and sexually active males with such partners must agree to use effective contraception during the study and for at least 28 days after last study drug dose
- MRD negative status measured by Euroflow NGF after first-line therapy
- Received first-line treatment in part 1 of the study
- ECOG performance status score 0, 1, or 2
You will not qualify if you...
- Received more than one cycle of induction treatment for multiple myeloma
- Ongoing or active systemic infection, active hepatitis B or C infection, or known HIV positive
- Concurrent medical or psychiatric conditions incompatible with high-dose therapy and stem cell transplantation or likely to reduce study compliance
- Presence of active malignancy with life expectancy shorter than that of myeloma
- Positive serum pregnancy test during the screening period
- Lactating female patients unwilling to stop lactating before treatment start
- Known allergy to any study medications, their analogues, or excipients
AI-Screening
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Trial Site Locations
Total: 13 locations
1
Ålesund Hospital
Ålesund, Norway
Actively Recruiting
2
Haukeland University Hospital
Bergen, Norway
Actively Recruiting
3
Nordland Hospital Bodø
Bodø, Norway
Actively Recruiting
4
Sykehuset Ostfold
Fredrikstad, Norway
Actively Recruiting
5
Førde Central Hospital
Førde, Norway
Actively Recruiting
6
Sørlandet Hospital Kristiansand
Kristiansand, Norway
Actively Recruiting
7
Levanger Hospital
Levanger, Norway
Actively Recruiting
8
Akershus University Hospital
Lørenskog, Norway
Actively Recruiting
9
Oslo University Hospital
Oslo, Norway
Actively Recruiting
10
Helse Stavanger HF
Stavanger, Norway
Actively Recruiting
11
University Hospital North Norway
Tromsø, Norway
Actively Recruiting
12
St. Olavs Hospital
Trondheim, Norway
Actively Recruiting
13
The Hospital of Vestfold
Tønsberg, Norway
Actively Recruiting
Research Team
A
Anne-Marie Rasmussen, PhD
CONTACT
A
Anna Lysen, MSC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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