The Norwegian Immunotherapy in Multiple Myeloma Study (NIMMS)

July 17, 2026 updated by: St. Olavs Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Tobias S Slørdahl, MD PhD
Phone Number: +4772825100
Email: tobias.s.slordahl@ntnu.no

Study Contact Backup

Name: Juni S Paulsen, MD
Phone Number: +4772825100
Email: juni.paulsen@ntnu.no

Study Locations

Norway
- - Arendal, Norway
    - Not yet recruiting
    - Sørlandet Hospital - Arendal
    - Contact:
      
      Silje Beate Holck-Steen, MD
      
      Phone Number: +47 38 07 30 00
      
      Email: silbel@sshf.no
  - Bergen, Norway
    - Not yet recruiting
    - Haukeland University Hospital
    - Contact:
      
      Galina Tsykunova, MD
      
      Phone Number: +47 55 97 37 00
      
      Email: galina.tsykunova@helse-bergen.no
  - Bodø, Norway
    - Not yet recruiting
    - Bodø Hospital
    - Contact:
      
      Terje Solhaug, MD
      
      Phone Number: +47 75 53 40 00
      
      Email: Terje.Singsaas.Solhaug@nordlandssykehuset.no
  - Bærum, Norway
    - Not yet recruiting
    - Bærum Hospital
    - Contact:
      
      Hanne Kristin Fredly, MD
      
      Phone Number: +47 32 80 30 30
      
      Email: Hanne.Kristin.Fredly@vestreviken.no
  - Drammen, Norway
    - Not yet recruiting
    - Drammen Hospital
    - Contact:
      
      Anne Elisabeth Tónay, MD
      
      Phone Number: +47 32 80 30 30
      
      Email: antona@vestreviken.no
  - Førde, Norway
    - Not yet recruiting
    - Førde hospital
    - Contact:
      
      Damian Szatkowski, MD
      
      Phone Number: +47 57 83 90 00
      
      Email: damian.lukasz.szatkowski@helse-forde.no
  - Gjøvik, Norway
    - Not yet recruiting
    - Innlandet Hospital Trust
    - Contact:
      
      Kristoffer Winje, MD
      
      Phone Number: +47 915 06 200
      
      Email: Kristoffer.Winje.Hagen@sykehuset-innlandet.no
  - Haugesund, Norway
    - Not yet recruiting
    - Haugesund hospital
    - Contact:
      
      Camilla S Bjørnsen, MD PhD
      
      Phone Number: +47 52 73 90 00
      
      Email: camilla.stapnes.bjornsen@helse-fonna.no
  - Kristiansand, Norway
    - Not yet recruiting
    - Sørlandet hospital
    - Contact:
      
      Hedda Lerdal, MD
      
      Phone Number: +47 38 07 30 00
      
      Email: hedda.lerdal@sshf.no
  - Kristiansund, Norway
    - Not yet recruiting
    - Nordmøre and Romsdal Hospital - Kristiansund
    - Contact:
      
      Tarjei S Rønning, MD
      
      Phone Number: +47 71 12 00 00
      
      Email: Tarjei.Skeide.Ronning@helse-mr.no
  - Levanger, Norway
    - Not yet recruiting
    - Levanger hospital
    - Contact:
      
      Vidar Stavseth, MD
      
      Phone Number: +47 74 09 80 00
      
      Email: vidar.stavseth@helse-nordtrondelag.no
  - Molde, Norway
    - Not yet recruiting
    - Nordmøre and Romsdal Hospital - Molde
    - Contact:
      
      Per Arne Standal, MD
      
      Phone Number: +47 71 12 00 00
      
      Email: Per.Arne.Standal@helse-mr.no
  - Nordbyhagen, Norway
    - Not yet recruiting
    - Akershus University Hospital (AHUS)
    - Contact:
      
      Anette L Eilertsen, MD PhD
      
      Phone Number: +47 67 96 00 00
      
      Email: Anette.Loken.Eilertsen@ahus.no
  - Oslo, Norway
    - Not yet recruiting
    - Diakonhjemmet Hospital
    - Contact:
      
      Erik Ø Bjørnestad, MD
      
      Phone Number: +47 22 45 15 00
      
      Email: e-bjorne@diakonsyk.no
  - Oslo, Norway
    - Not yet recruiting
    - Lovisenberg Diaconal Hospital
    - Contact:
      
      Astrid Bergrem, MD PhD
      
      Phone Number: +47 23 22 50 00
      
      Email: bast@lds.no
  - Oslo, Norway
    - Not yet recruiting
    - Oslo Myeloma Center, Oslo University Hospital
    - Contact:
      
      Ingerid W Abrahamsen, MD PhD
      
      Phone Number: +47 23 07 04 60
      
      Email: inabra@ous-hf.no
  - Skien, Norway
    - Not yet recruiting
    - Telemark Hospital Trust
    - Contact:
      
      Lloyd Frode Ramslien, MD
      
      Phone Number: +47 35 00 35 00
      
      Email: ramf@sthf.no
  - Stavanger, Norway
    - Not yet recruiting
    - Stavanger University Hospital
    - Contact:
      
      Kari Lenita F Moore, MD
      
      Phone Number: +47 51 51 90 50
      
      Email: kari.lenita.falck.moore@sus.no
  - Tromsø, Norway
    - Not yet recruiting
    - University Hospital of North Norway
    - Contact:
      
      Gøril Heide, MD PhD
      
      Phone Number: +47 77 62 60 00
      
      Email: Goril.Heide@unn.no
  - Trondheim, Norway
    - Recruiting
    - St. Olavs hospital HF
    - Contact:
      
      Tobias S Slørdahl, MD PhD
      
      Phone Number: +4772825100
      
      Email: tobias.s.slordahl@ntnu.no
  - Tønsberg, Norway
    - Not yet recruiting
    - Vestfold Hospital Trust
    - Contact:
      
      Magnus Moksnes, MD
      
      Phone Number: +47 33342000
      
      Email: magmok@siv.no
  - Volda, Norway
    - Not yet recruiting
    - Volda hospital
    - Contact:
      
      Elin O Velle, MD
      
      Phone Number: +47 70 10 50 00
      
      Email: Elin.Osvik.Velle@helse-mr.no
  - Ålesund, Norway
    - Not yet recruiting
    - Ålesund hospital, Department of hematology
    - Contact:
      
      Eivind Samstad, MD PhD
      
      Phone Number: +47 70 10 50 00
      
      Email: eivind.samstad@ntnu.no

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

Patients with multiple myeloma, plasma cell leukemia or AL amyloidosis treated at study sites outside clinical trials.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.		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.		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.		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.		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	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). Time Frame: From start of treatment and until start of next treatment or death, assessed up to ten years.		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.		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.		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.		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.		From enrollment and until end of treatment, assessed up to ten years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Collaborators

Vestre Viken Hospital Trust

Oslo University Hospital

University Hospital of North Norway

Norwegian University of Science and Technology

Diakonhjemmet Hospital

Helse Stavanger HF

Haukeland University Hospital

Sorlandet Hospital HF

Sykehuset Innlandet HF

Helse Nord-Trøndelag HF

Helse Fonna

University Hospital, Akershus

Molde Hospital

Sykehuset i Vestfold Hospital Trust

Lovisenberg Diakonale Hospital

Kristiansund Hospital

Volda Hospital

Telemark Hospital Trust

Ålesund Hospital, Norway

Bodø Hospital, Norway

Førde Hospital Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

December 1, 2037

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 3, 2025

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NIMMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.