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Recruiting NCT06855121

The Norwegian Immunotherapy in Multiple Myeloma Study

— Observational Myeloma Multiple Plasma Cell Leukemia AL Amyloidosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Teclistamab, Elranatamab, Ciltacabtagene Autoleucel, Talquetamab.
Who it may be relevant to
Registry conditions: Myeloma Multiple, Plasma Cell Leukemia, AL Amyloidosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Teclistamab
    Real-world use and dosing
  • Drug Elranatamab
    Real-world use and dosing
  • Biological Ciltacabtagene Autoleucel
    Real-world use.
  • Drug Talquetamab
    Real-world use and dosing
  • Biological Idecabtagene vicleucel
    Real-world use and dosing

Primary outcome measures

  • 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.]
  • 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.]
  • 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.]
  • Determine real-world overall survival (OS) [Time frame: From date of treatment start and until death, assessed up to ten years.]
  • Describe the frequency and grading of adverse events of special interest (AESI), defined as described below. [Time frame: 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]
  • Frequency and grading of all other adverse events occurring during treatment according to CTCAE 5.0 (only grade 3 or higher will be reported). [Time frame: From start of treatment and until start of next treatment or death, assessed up to ten years.]
  • Describe the microbiological pattern (positive cultures/PCR) of infections during treatment. [Time frame: From start of treatment and start of next treatment line or death, assessed up to ten years.]
  • Describe the antibiotic resistance pattern of positive cultures. [Time frame: From start of treatment and start of next treatment line or death, assessed up to ten years.]
  • Describe the prevalence of common airway viruses during treatment and at end-of-treatment. [Time frame: From date of start of treatment and until end of treatment, assessed up to ten years.]
  • Determine the real-world use of antimicrobial prophylaxis (antibiotics, antivirals, vaccines, immunoglobulines) before and during therapy. [Time frame: From enrollment and until end of treatment, assessed up to ten years.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Norway · 23 centers
  • Sørlandet Hospital - Arendal — Arendal
  • Ålesund hospital, Department of hematology — Ålesund
  • Haukeland University Hospital — Bergen
  • Bodø Hospital — Bodø
  • Bærum Hospital — Bærum
  • Drammen hospital — Drammen
  • Førde hospital — Førde
  • Innlandet hospital trust — Gjøvik
  • … and 15 more centers

Identifiers

NCT: NCT06855121 · NIMMS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗