Clinical trial · Observational
The Norwegian Immunotherapy in Multiple Myeloma Study
The Norwegian Immunotherapy in Multiple Myeloma Study - A Population-based Longitudinal Observational Multicenter Study on Effectiveness and Complications of Immunotherapy in Multiple Myeloma in the Norwegian Myeloma Cohort
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to study the effectiveness and complications of novel immunotherapies used in the treatment of multiple myeloma in routine care in Norway. The aim is to close knowledge gaps, generate evidence for future clinical trials and contribute to future consensus on how to monitor for adverse events, and what mitigation strategies should be implemented, so that we can increase patient survival and quality-of-life.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AL Amyloidosis | AL Amyloidosis | ONTOLOGY_EXACT | 0.98 |
| Myeloma Multiple | Multiple Myeloma | ALIAS | 0.90 |
| Plasma Cell Leukemia | Plasma Cell Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ciltacabtagene Autoleucel | Biological | Ciltacabtagene Autoleucel | ALIAS |
| Elranatamab | Drug | Elranatamab | ALIAS |
| Idecabtagene vicleucel | Biological | Idecabtagene Vicleucel | ALIAS |
| Talquetamab | Drug | Talquetamab | ALIAS |
| Teclistamab | Drug | Teclistamab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (10)
- measure
- Determine the real-world overall response rates (ORR)
- timeFrame
- From date of treatment start and until date of first documented progression or start of next line of therapy, whichever came first, assessed up to ten years.
- measure
- Determine real-world progression-free survival (PFS)
- timeFrame
- From date of treatment start and until date of first documented progression or death, whichever came first, , assessed up to ten years.
- measure
- Determine real-world time-to-next treatment (TTNT)
- timeFrame
- From date of treatment start and until date of start of next treatment, assessed up to ten years.
- measure
- Determine real-world overall survival (OS)
- timeFrame
- From date of treatment start and until death, assessed up to ten years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * Participants age ≥ 18 years * Prior diagnosis of one of the following * Multiple myeloma as defined according to IMWG criteria * Primary plasma cell leukemia as defined according to IMWG consensus definition * AL-amyloidosis as defined according to IMWG criteria * Planned treatment with one of the following outside clinical trials (list to be amended based on approvals within the EU): * Teclistamab (Tecvayli) * Elranatamab (Elrexfio) * Talquetamab (Talvey) * Idecabtagene vicleucel (ide-cel/Abecma) * Ciltacabtagene autoleucel (cilta-cel/Carvykti) Exclusion Criteria: * None
References
Publications (0)
Data not yet available