NCT04513639 The Relapse from MRD Negativity As Indication for Treatment (REMNANT) Study
| NCT ID | NCT04513639 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Oslo University Hospital |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 176 participants |
| Start Date | 2020-08-27 |
| Primary Completion | 2031-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 176 participants in total. It began in 2020-08-27 with a primary completion date of 2031-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria part one: * Each patient must meet all of the following inclusion criteria to be enrolled in the study: 1. Patient with newly diagnosed multiple myeloma (IMWG criteria) eligible for high-dose therapy and ASCT. 2. Patient must be \>18 and \< 75 years of age at the time of signing the informed consent 3. 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. 4. Voluntary written informed consent 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. ECOG 3 can be enrolled if caused by myeloma. 6. Patient must be willing and able to adhere to the study protocol visit schedule and other protocol requirements. 7. Female of childbearing potential (FCBP) must have a confirmed negative serum pregnancy test within 7 days prior to inclusion. 8. 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). Inclusion Criteria part two: * Each patient must meet all of the following inclusion criteria to be enrolled in the study 1. Patient must be MRD negative measured by Euroflow NGF after 1.L therapy. The cutoff for inclusion into part 2 will be 100 PC per 10 mill. nucleated cells monitored in BM. 2. Has received 1.L treatment in part 1 of the study. 3. ECOG performance status score 0, 1 or 2 Exclusion Criteria part one: 1. Received more than one cycle of induction treatment for multiple myeloma. 2. Patient with ongoing or active systemic infection, active hepatitis B or C virus infection or known human immunodeficiency virus (HIV) positive 3. 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. 4. No active malignancy with a lower life expectancy than myeloma 5. Female patient who have a positive serum pregnancy test during the screening period. 6. Female patient who is lactating during the screening period but are not willing to stop lactating prior to the first treatment cycle starts. 7. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent. Exclusion Criteria part two: 1. No active malignancy with a lower life expectancy than myeloma 2. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
Contact & Investigator
Fredrik Schjesvold, MD, PhD
PRINCIPAL INVESTIGATOR
Oslo University Hospital
Frequently Asked Questions
Who can join the NCT04513639 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04513639 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04513639 currently recruiting?
Yes, NCT04513639 is actively recruiting participants. Contact the research team at annemra55@gmail.com for enrollment information.
Where is the NCT04513639 trial being conducted?
This trial is being conducted at Ålesund, Norway, Bergen, Norway, Bodø, Norway, Fredrikstad, Norway and 9 additional locations.
Who is sponsoring the NCT04513639 clinical trial?
NCT04513639 is sponsored by Oslo University Hospital. The principal investigator is Fredrik Schjesvold, MD, PhD at Oslo University Hospital. The trial plans to enroll 176 participants.