Observational study on immunotherapy for multiple myeloma in Norway
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
This study looks at how well new immunotherapy treatments for multiple myeloma work and what side effects they may cause for patients in Norway.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Olavs Hospital Academic / other |
| Drugs / interventions | Teclistamab, Elranatamab, Talquetamab |
| Locations | 23 sites (Arendal and 22 other locations) |
| Trial ID | NCT06855121 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness and complications of novel immunotherapies for multiple myeloma in routine clinical care across Norway. It focuses on treatments such as teclistamab, elranatamab, and cilta-cel, among others. By closing knowledge gaps and generating evidence, the study seeks to inform future clinical trials and establish consensus on monitoring adverse events and implementing mitigation strategies to enhance patient survival and quality of life.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of multiple myeloma, primary plasma cell leukemia, or AL amyloidosis who are planning to receive specific immunotherapies.
Not a fit: Patients who do not have a diagnosis of multiple myeloma, plasma cell leukemia, or AL amyloidosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and quality of life for patients with multiple myeloma and related conditions.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, indicating potential for success in this observational study.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Arendal and 22 other locations
- Sørlandet Hospital - Arendal — Arendal, Norway (Not_yet_recruiting)
- Ålesund hospital, Department of hematology — Ålesund, Norway (Not_yet_recruiting)
- Haukeland University Hospital — Bergen, Norway (Not_yet_recruiting)
- Bodø Hospital — Bodø, Norway (Not_yet_recruiting)
- Bærum Hospital — Bærum, Norway (Not_yet_recruiting)
- Drammen hospital — Drammen, Norway (Not_yet_recruiting)
- Førde hospital — Førde, Norway (Not_yet_recruiting)
- Innlandet hospital trust — Gjøvik, Norway (Not_yet_recruiting)
- Haugesund hospital — Haugesund, Norway (Not_yet_recruiting)
- Sørlandet hospital — Kristiansand, Norway (Not_yet_recruiting)
- Nordmøre and Romsdal Hospital - Kristiansund — Kristiansund, Norway (Not_yet_recruiting)
- Levanger hospital — Levanger, Norway (Not_yet_recruiting)
- Nordmøre and Romsdal Hospital - Molde — Molde, Norway (Not_yet_recruiting)
- Akershus University Hospital (AHUS) — Nordbyhagen, Norway (Not_yet_recruiting)
- Diakonhjemmet hospital — Oslo, Norway (Not_yet_recruiting)
- Lovisenberg Diaconal Hospital — Oslo, Norway (Not_yet_recruiting)
- Oslo Myeloma Center, Oslo University Hospital — Oslo, Norway (Not_yet_recruiting)
- Telemark Hospital Trust — Skien, Norway (Not_yet_recruiting)
- Stavanger University hospital — Stavanger, Norway (Not_yet_recruiting)
- University hospital of North Norway — Tromsø, Norway (Not_yet_recruiting)
- St. Olavs hospital HF — Trondheim, Norway (Recruiting)
- Vestfold Hospital Trust — Tønsberg, Norway (Not_yet_recruiting)
- Volda hospital — Volda, Norway (Not_yet_recruiting)
Study contacts
- Study coordinator: Tobias S Slørdahl, MD PhD
- Email: tobias.s.slordahl@ntnu.no
- Phone: +4772825100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.