Clinical trial NCT06855121: The Norwegian Immunotherapy in Multiple Myeloma Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myeloma Multiple
Plasma Cell Leukemia
AL Amyloidosis
Keywords: bispesific antibodies
teclistamab
elranatamab
talquetamab
cilta-cel
ide-cel
ciltacabtagene autoleucel
idecabtagene vicleucel
CRS
ICAN
infections
supportive care
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: Haukeland University Hospital
name: Helse Stavanger HF
name: Oslo University Hospital
name: University Hospital, Akershus
name: Sykehuset i Vestfold Hospital Trust
name: University Hospital of North Norway
name: Ålesund Hospital, Norway
name: Helse Nord-Trøndelag HF
name: Sorlandet Hospital HF
name: Førde Hospital Trust
name: Molde Hospital
name: Bodø Hospital, Norway
name: Helse Fonna
name: Volda Hospital
name: Diakonhjemmet Hospital
name: Telemark Hospital Trust
name: Kristiansund Hospital
name: Vestre Viken Hospital Trust
name: Lovisenberg Diakonale Hospital
name: Sykehuset Innlandet HF
First posted: 2025-03-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with multiple myeloma, plasma cell leukemia or AL amyloidosis treated at study sites outside clinical trials.

Brief 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 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

Primary outcomes:
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.
measure: Describe the frequency and grading of adverse events of special interest (AESI), defined as described below.
timeFrame: From date of treatment start until the date of start of next line of treatment or death, whichever came first, assessed up to 10 years
measure: Frequency and grading of all other adverse events occurring during treatment according to CTCAE 5.0 (only grade 3 or higher will be reported).
timeFrame: From start of treatment and until start of next treatment or death, assessed up to ten years.
measure: Describe the microbiological pattern (positive cultures/PCR) of infections during treatment.
timeFrame: From start of treatment and start of next treatment line or death, assessed up to ten years.
measure: Describe the antibiotic resistance pattern of positive cultures.
timeFrame: From start of treatment and start of next treatment line or death, assessed up to ten years.
measure: Describe the prevalence of common airway viruses during treatment and at end-of-treatment.
timeFrame: From date of start of treatment and until end of treatment, assessed up to ten years.
measure: Determine the real-world use of antimicrobial prophylaxis (antibiotics, antivirals, vaccines, immunoglobulines) before and during therapy.
timeFrame: From enrollment and until end of treatment, assessed up to ten years.
Secondary outcomes:
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Sørlandet Hospital - Arendal
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Bodø
country: Norway
facility: Bodø Hospital
city: Bærum
country: Norway
facility: Bærum Hospital
city: Drammen
country: Norway
facility: Drammen hospital
city: Førde
country: Norway
facility: Førde hospital
city: Gjøvik
country: Norway
facility: Innlandet hospital trust
city: Haugesund
country: Norway
facility: Haugesund hospital
city: Kristiansand
country: Norway
facility: Sørlandet hospital
city: Kristiansund
country: Norway
facility: Nordmøre and Romsdal Hospital - Kristiansund
city: Levanger
country: Norway
facility: Levanger hospital
city: Molde
country: Norway
facility: Nordmøre and Romsdal Hospital - Molde
city: Nordbyhagen
country: Norway
facility: Akershus University Hospital (AHUS)
city: Oslo
country: Norway
facility: Diakonhjemmet hospital
city: Oslo
country: Norway
facility: Lovisenberg Diaconal Hospital
city: Oslo
country: Norway
facility: Oslo Myeloma Center, Oslo University Hospital
city: Skien
country: Norway
facility: Telemark Hospital Trust
city: Stavanger
country: Norway
facility: Stavanger University hospital
city: Tromsø
country: Norway
facility: University hospital of North Norway
city: Trondheim
country: Norway
facility: St. Olavs hospital HF
city: Tønsberg
country: Norway
facility: Vestfold Hospital Trust
city: Volda
country: Norway
facility: Volda hospital
city: Ålesund
country: Norway
facility: Ålesund hospital, Department of hematology
Study officials:
References: