RecruitingNCT06855121

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


Sponsor

St. Olavs Hospital

Enrollment

400 participants

Start Date

Jan 15, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria11

  • 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 Criteria1

  • None

Interventions

DRUGTeclistamab

Real-world use and dosing

DRUGElranatamab

Real-world use and dosing

BIOLOGICALCiltacabtagene Autoleucel

Real-world use.

DRUGTalquetamab

Real-world use and dosing

BIOLOGICALIdecabtagene vicleucel

Real-world use and dosing


Locations(23)

Sørlandet Hospital - Arendal

Arendal, Norway

Ålesund hospital, Department of hematology

Ålesund, Norway

Haukeland University Hospital

Bergen, Norway

Bodø Hospital

Bodø, Norway

Bærum Hospital

Bærum, Norway

Drammen hospital

Drammen, Norway

Førde hospital

Førde, Norway

Innlandet hospital trust

Gjøvik, Norway

Haugesund hospital

Haugesund, Norway

Sørlandet hospital

Kristiansand, Norway

Nordmøre and Romsdal Hospital - Kristiansund

Kristiansund, Norway

Levanger hospital

Levanger, Norway

Nordmøre and Romsdal Hospital - Molde

Molde, Norway

Akershus University Hospital (AHUS)

Nordbyhagen, Norway

Diakonhjemmet hospital

Oslo, Norway

Lovisenberg Diaconal Hospital

Oslo, Norway

Oslo Myeloma Center, Oslo University Hospital

Oslo, Norway

Telemark Hospital Trust

Skien, Norway

Stavanger University hospital

Stavanger, Norway

University hospital of North Norway

Tromsø, Norway

St. Olavs hospital HF

Trondheim, Norway

Vestfold Hospital Trust

Tønsberg, Norway

Volda hospital

Volda, Norway

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NCT06855121


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