The Norwegian Immunotherapy in Multiple Myeloma Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSt. Olavs Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Patients with multiple myeloma, plasma cell leukemia or AL amyloidosis treated at study sites outside clinical trials.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Teclistamab
DrugReal-world use and dosing
Elranatamab
DrugReal-world use and dosing
Ciltacabtagene Autoleucel
Biological/VaccineReal-world use.
Talquetamab
DrugReal-world use and dosing
Idecabtagene vicleucel
Biological/VaccineReal-world use and dosing
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Determine the real-world overall response rates (ORR)
Time frame
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.2
Determine real-world progression-free survival (PFS)
Time frame
From date of treatment start and until date of first documented progression or death, whichever came first, , assessed up to ten years.3
Determine real-world time-to-next treatment (TTNT)
Time frame
From date of treatment start and until date of start of next treatment, assessed up to ten years.4
Determine real-world overall survival (OS)
Time frame
From date of treatment start and until death, assessed up to ten years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Olavs Hospital
Lead sponsor
Norwegian University of Science and Technology
Collaborator
Haukeland University Hospital
Collaborator
Helse Stavanger HF
Collaborator
Oslo University Hospital
Collaborator
University Hospital, Akershus
Collaborator
Sykehuset i Vestfold Hospital Trust
Collaborator
University Hospital of North Norway
Collaborator
Ålesund Hospital, Norway
Collaborator
Helse Nord-Trøndelag HF
Collaborator
Sorlandet Hospital HF
Collaborator
Førde Hospital Trust
Collaborator
Molde Hospital
Collaborator
Bodø Hospital, Norway
Collaborator
Helse Fonna
Collaborator
Volda Hospital
Collaborator
Diakonhjemmet Hospital
Collaborator
Telemark Hospital Trust
Collaborator
Kristiansund Hospital
Collaborator
Vestre Viken Hospital Trust
Collaborator
Lovisenberg Diakonale Hospital
Collaborator
Sykehuset Innlandet HF
Collaborator
Source ClinicalTrials.gov