The Norwegian Immunotherapy in Multiple Myeloma Study

ClinicalTrials.gov ID

NCT06855121

Lead Sponsor

St. Olavs HospitalOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

400Estimated

Last Update Posted

Jul 20, 2026Actual

Start Date

Jan 15, 2025Actual

Primary Completion Date

Jan 2029Estimated

Completion Date

Dec 1, 2037Estimated

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

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.

• Myeloma Multiple
• Plasma Cell Leukemia
• AL Amyloidosis

• Teclistamab
• Elranatamab
• Ciltacabtagene Autoleucel
• Talquetamab
• Idecabtagene vicleucel

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

St. Olavs HospitalOTHER

Collaborators

Norwegian University of Science and TechnologyOTHER

Haukeland University HospitalOTHER

Helse Stavanger HFOTHER_GOV

Oslo University HospitalOTHER

University Hospital, AkershusOTHER

Sykehuset i Vestfold Hospital TrustUNKNOWN

University Hospital of North NorwayOTHER

Ålesund Hospital, NorwayUNKNOWN

Helse Nord-Trøndelag HFOTHER

Sorlandet Hospital HFOTHER_GOV

Førde Hospital TrustOTHER

Molde HospitalOTHER

Bodø Hospital, NorwayUNKNOWN

Helse FonnaOTHER

Volda HospitalOTHER

Diakonhjemmet HospitalOTHER

Telemark Hospital TrustUNKNOWN

Kristiansund HospitalOTHER

Vestre Viken Hospital TrustOTHER

Lovisenberg Diakonale HospitalOTHER

Sykehuset Innlandet HFOTHER

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eivind.samstad@ntnu.no+47 70 10 50 00

galina.tsykunova@helse-bergen.no+47 55 97 37 00

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

antona@vestreviken.no+47 32 80 30 30

damian.lukasz.szatkowski@helse-forde.no+47 57 83 90 00

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

camilla.stapnes.bjornsen@helse-fonna.no+47 52 73 90 00

hedda.lerdal@sshf.no+47 38 07 30 00

vidar.stavseth@helse-nordtrondelag.no+47 74 09 80 00

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

e-bjorne@diakonsyk.no+47 22 45 15 00

bast@lds.no+47 23 22 50 00

ramf@sthf.no+47 35 00 35 00

kari.lenita.falck.moore@sus.no+47 51 51 90 50

Goril.Heide@unn.no+47 77 62 60 00

tobias.s.slordahl@ntnu.no+4772825100

magmok@siv.no+47 33342000

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