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Myeloma MultipleNIMMSNCT06855121

The Norwegian Immunotherapy in Multiple Myeloma Study

An observational study of Myeloma Multiple and Plasma Cell Leukemia, run by St. Olavs Hospital at 23 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Teclistamab, Elranatamab and Ciltacabtagene Autoleucel
How many people
400 participants
Where
23 sitesNorway
Study dates
15 Jan 2025to 1 Dec 2037
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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):
Show all 11Show fewer
  • Teclistamab (Tecvayli)
  • Elranatamab (Elrexfio)
  • Talquetamab (Talvey)
  • Idecabtagene vicleucel (ide-cel/Abecma)
  • Ciltacabtagene autoleucel (cilta-cel/Carvykti)

Who cannot join

  • None

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tobias S Slørdahl, MD PhD contact

+4772825100

tobias.s.slordahl@ntnu.no

Juni S Paulsen, MD contact

+4772825100

juni.paulsen@ntnu.no

23 sites in 1 country

Norway23 sites, 23 recruiting

  • Ålesund hospital, Department of hematology

    Ålesund

    Eivind Samstad, MD PhD, +47 70 10 50 00, eivind.samstad@ntnu.no

    Not yet recruiting

  • Sørlandet Hospital - Arendal

    Arendal

    Silje Beate Holck-Steen, MD, +47 38 07 30 00, silbel@sshf.no

    Not yet recruiting

  • Bærum Hospital

    Bærum

    Hanne Kristin Fredly, MD, +47 32 80 30 30, Hanne.Kristin.Fredly@vestreviken.no

    Not yet recruiting

  • Haukeland University Hospital

    Bergen

    Galina Tsykunova, MD, +47 55 97 37 00, galina.tsykunova@helse-bergen.no

    Not yet recruiting

  • Bodø Hospital

    Bodø

    Terje Solhaug, MD, +47 75 53 40 00, Terje.Singsaas.Solhaug@nordlandssykehuset.no

    Not yet recruiting

  • Drammen hospital

    Drammen

    Anne Elisabeth Tónay, MD, +47 32 80 30 30, antona@vestreviken.no

    Not yet recruiting

  • Førde hospital

    Førde

    Damian Szatkowski, MD, +47 57 83 90 00, damian.lukasz.szatkowski@helse-forde.no

    Not yet recruiting

  • Innlandet hospital trust

    Gjøvik

    Kristoffer Winje, MD, +47 915 06 200, Kristoffer.Winje.Hagen@sykehuset-innlandet.no

    Not yet recruiting

  • Haugesund hospital

    Haugesund

    Camilla S Bjørnsen, MD PhD, +47 52 73 90 00, camilla.stapnes.bjornsen@helse-fonna.no

    Not yet recruiting

  • Sørlandet hospital

    Kristiansand

    Hedda Lerdal, MD, +47 38 07 30 00, hedda.lerdal@sshf.no

    Not yet recruiting

  • Nordmøre and Romsdal Hospital - Kristiansund

    Kristiansund

    Tarjei S Rønning, MD, +47 71 12 00 00, Tarjei.Skeide.Ronning@helse-mr.no

    Not yet recruiting

  • Levanger hospital

    Levanger

    Vidar Stavseth, MD, +47 74 09 80 00, vidar.stavseth@helse-nordtrondelag.no

    Not yet recruiting

  • Nordmøre and Romsdal Hospital - Molde

    Molde

    Per Arne Standal, MD, +47 71 12 00 00, Per.Arne.Standal@helse-mr.no

    Not yet recruiting

  • Akershus University Hospital (AHUS)

    Nordbyhagen

    Anette L Eilertsen, MD PhD, +47 67 96 00 00, Anette.Loken.Eilertsen@ahus.no

    Not yet recruiting

  • Diakonhjemmet hospital

    Oslo

    Erik Ø Bjørnestad, MD, +47 22 45 15 00, e-bjorne@diakonsyk.no

    Not yet recruiting

  • Lovisenberg Diaconal Hospital

    Oslo

    Astrid Bergrem, MD PhD, +47 23 22 50 00, bast@lds.no

    Not yet recruiting

  • Oslo Myeloma Center, Oslo University Hospital

    Oslo

    Ingerid W Abrahamsen, MD PhD, +47 23 07 04 60, inabra@ous-hf.no

    Not yet recruiting

  • Telemark Hospital Trust

    Skien

    Lloyd Frode Ramslien, MD, +47 35 00 35 00, ramf@sthf.no

    Not yet recruiting

  • Stavanger University hospital

    Stavanger

    Kari Lenita F Moore, MD, +47 51 51 90 50, kari.lenita.falck.moore@sus.no

    Not yet recruiting

  • Vestfold Hospital Trust

    Tønsberg

    Magnus Moksnes, MD, +47 33342000, magmok@siv.no

    Not yet recruiting

  • University hospital of North Norway

    Tromsø

    Gøril Heide, MD PhD, +47 77 62 60 00, Goril.Heide@unn.no

    Not yet recruiting

  • St. Olavs hospital HF

    Trondheim

    Tobias S Slørdahl, MD PhD, +4772825100, tobias.s.slordahl@ntnu.no

    Recruiting

  • Volda hospital

    Volda

    Elin O Velle, MD, +47 70 10 50 00, Elin.Osvik.Velle@helse-mr.no

    Not yet recruiting

Other trials in Norway

About this 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

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.

Being tested
Teclistamab, Elranatamab, Ciltacabtagene Autoleucel, Talquetamab, Idecabtagene vicleucel
Keywords
bispesific antibodies, teclistamab, elranatamab, talquetamab, cilta-cel, ide-cel, ciltacabtagene autoleucel, idecabtagene vicleucel, CRS, ICAN, infections, supportive care
Medical subject headings
Multiple Myeloma, Leukemia, Plasma Cell, Immunoglobulin Light-chain Amyloidosis, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TeclistamabDrug

    Real-world use and dosing

  • ElranatamabDrug

    Real-world use and dosing

  • Ciltacabtagene AutoleucelBiological

    Real-world use.

  • TalquetamabDrug

    Real-world use and dosing

  • Idecabtagene vicleucelBiological

    Real-world use and dosing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the real-world overall response rates (ORR)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: From date of treatment start and until death, assessed up to ten years.

  5. 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)

    Measured: 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

  6. Frequency and grading of all other adverse events occurring during treatment according to CTCAE 5.0 (only grade 3 or higher will be reported).

    Measured: From start of treatment and until start of next treatment or death, assessed up to ten years.

  7. Describe the microbiological pattern (positive cultures/PCR) of infections during treatment.

    Measured: From start of treatment and start of next treatment line or death, assessed up to ten years.

  8. Describe the antibiotic resistance pattern of positive cultures.

    Measured: From start of treatment and start of next treatment line or death, assessed up to ten years.

  9. Describe the prevalence of common airway viruses during treatment and at end-of-treatment.

    Measured: From date of start of treatment and until end of treatment, assessed up to ten years.

  10. Determine the real-world use of antimicrobial prophylaxis (antibiotics, antivirals, vaccines, immunoglobulines) before and during therapy.

    Measured: From enrollment and until end of treatment, assessed up to ten years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2025
  2. Study start15 Jan 2025
  3. Primary completionJan 2029 (estimated)
  4. Study completion1 Dec 2037 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06855121
Sponsor's protocol ID
NIMMS
Acronym
NIMMS
Status last verified
Jul 2026
First submitted
24 Jan 2025
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Myeloma Multiple and Plasma Cell Leukemia, run by St. Olavs Hospital at 23 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tobias S Slørdahl, MD PhD (+4772825100, tobias.s.slordahl@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06855121.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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