The Norwegian Immunotherapy in Multiple Myeloma Study
NIMMS
1 other identifier
observational
400
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2025
Longer than P75 for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2025
CompletedFirst Submitted
Initial submission to the registry
January 24, 2025
CompletedFirst Posted
Study publicly available on registry
March 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2037
March 3, 2025
February 1, 2025
4 years
January 24, 2025
February 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Determine the real-world overall response rates (ORR)
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)
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)
From date of treatment start and until date of start of next treatment, assessed up to ten years.
Determine real-world overall survival (OS)
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.
* Cytokine release syndrome (CRS) (ASTCT grade 1-5), * Infections (CTCAE grade 1-5) * Neurological adverse events (including, but not limited to, ICANS, peripheral sensory and/or motor neuropathy, neurocognitive and hypokinetic movement disorder) (CTCAE 5.0. grade 1-5). * Immune effector cell-associated hematotoxicity (ICAHT) (EHA/EBMT Consensus Grading 1-4)27 * Secondary malignancies, dysgeusia, skin- and nail adverse events, pain, hemophagocytic lymphohistiocytosis (HLH) and tumor lysis syndrome (CTCAE grade 1-5)
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).
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.
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.
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.
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.
From enrollment and until end of treatment, assessed up to ten years.
Interventions
Real-world use and dosing
Real-world use and dosing
Real-world use.
Real-world use and dosing
Real-world use and dosing
Eligibility Criteria
Patients with multiple myeloma, plasma cell leukemia or AL amyloidosis treated at study sites outside clinical trials.
You may qualify if:
- 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)
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Olavs Hospitallead
- Norwegian University of Science and Technologycollaborator
- Haukeland University Hospitalcollaborator
- Helse Stavanger HFcollaborator
- Oslo University Hospitalcollaborator
- University Hospital, Akershuscollaborator
- Sykehuset i Vestfold Hospital Trustcollaborator
- University Hospital of North Norwaycollaborator
- Ålesund Hospital, Norwaycollaborator
- Helse Nord-Trøndelag HFcollaborator
- Sorlandet Hospital HFcollaborator
- Førde Hospital Trustcollaborator
- Molde Hospitalcollaborator
- Bodø Hospital, Norwaycollaborator
- Helse Fonnacollaborator
- Volda Hospitalcollaborator
- Diakonhjemmet Hospitalcollaborator
- Telemark Hospital Trustcollaborator
- Kristiansund Hospitalcollaborator
- Vestre Viken Hospital Trustcollaborator
- Lovisenberg Diakonale Hospitalcollaborator
- Sykehuset Innlandet HFcollaborator
Study Sites (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
Biospecimen
Blood and bone marrow (in responding patients), nasopharyngeal secretion
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2025
First Posted
March 3, 2025
Study Start
January 15, 2025
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
December 1, 2037
Last Updated
March 3, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share