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

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug, Biological
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Norway
Ålesund hospital, Department of hematology
NOT_YET_RECRUITING
Ålesund
Sørlandet Hospital - Arendal
NOT_YET_RECRUITING
Arendal
Bærum Hospital
NOT_YET_RECRUITING
Bærum
Haukeland University Hospital
NOT_YET_RECRUITING
Bergen
Bodø Hospital
NOT_YET_RECRUITING
Bodø
Drammen hospital
NOT_YET_RECRUITING
Drammen
Førde hospital
NOT_YET_RECRUITING
Førde
Innlandet hospital trust
NOT_YET_RECRUITING
Gjøvik
Haugesund hospital
NOT_YET_RECRUITING
Haugesund
Sørlandet hospital
NOT_YET_RECRUITING
Kristiansand
Nordmøre and Romsdal Hospital - Kristiansund
NOT_YET_RECRUITING
Kristiansund
Levanger hospital
NOT_YET_RECRUITING
Levanger
Nordmøre and Romsdal Hospital - Molde
NOT_YET_RECRUITING
Molde
Akershus University Hospital (AHUS)
NOT_YET_RECRUITING
Nordbyhagen
Diakonhjemmet hospital
NOT_YET_RECRUITING
Oslo
Lovisenberg Diaconal Hospital
NOT_YET_RECRUITING
Oslo
Oslo Myeloma Center, Oslo University Hospital
NOT_YET_RECRUITING
Oslo
Telemark Hospital Trust
NOT_YET_RECRUITING
Skien
Stavanger University hospital
NOT_YET_RECRUITING
Stavanger
Vestfold Hospital Trust
NOT_YET_RECRUITING
Tønsberg
University hospital of North Norway
NOT_YET_RECRUITING
Tromsø
St. Olavs hospital HF
RECRUITING
Trondheim
Volda hospital
NOT_YET_RECRUITING
Volda
Contact Information
Primary
Tobias S Slørdahl, MD PhD
tobias.s.slordahl@ntnu.no
+4772825100
Backup
Juni S Paulsen, MD
juni.paulsen@ntnu.no
+4772825100
Time Frame
Start Date: 2025-01-15
Estimated Completion Date: 2037-12-01
Participants
Target number of participants: 400
Sponsors
Collaborators: Helse Fonna, Telemark Hospital Trust, Vestre Viken Hospital Trust, Helse Stavanger HF, Diakonhjemmet Hospital, Sorlandet Hospital HF, Molde Hospital, University Hospital of North Norway, Volda Hospital, Helse Nord-Trøndelag HF, Sykehuset i Vestfold Hospital Trust, Sykehuset Innlandet HF, Haukeland University Hospital, Lovisenberg Diakonale Hospital, Oslo University Hospital, University Hospital, Akershus, Ålesund Hospital, Norway, Bodø Hospital, Norway, Førde Hospital Trust, Kristiansund Hospital, Norwegian University of Science and Technology
Leads: St. Olavs Hospital

This content was sourced from clinicaltrials.gov