ClinicalTrials.gov record NCT06855121
The Norwegian Immunotherapy in Multiple Myeloma Study
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
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This prospective observational study collects real-world data on the effectiveness and complications of selected immunotherapies used in routine care for people with multiple myeloma, plasma cell leukemia, or AL amyloidosis. Participants are followed from the start of their immunotherapy and outcomes—including response, survival, time to next treatment, and specified adverse events and infection patterns—are recorded for up to ten years. The study does not assign treatments; it records what happens during usual care.
What it is studying. The study is documenting how selected immunotherapies perform in routine clinical care: real-world overall response rates, progression-free and overall survival, time-to-next treatment, the frequency and severity of prespecified adverse events (for example cytokine release syndrome, infections, neurological events, hematologic toxicities, and secondary malignancies), microbiological patterns of infections, antibiotic resistance, and use of antimicrobial prophylaxis.
What the researchers hope to learn. To fill knowledge gaps about how certain immunotherapies work and what complications occur in routine practice; to describe infection and resistance patterns; and to provide evidence to inform future clinical trials and recommendations on monitoring and managing adverse events.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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 being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Teclistamab
- Elranatamab
- Talquetamab
- Biological
- Ciltacabtagene Autoleucel
- Idecabtagene vicleucel
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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 description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive the planned immunotherapy as part of their routine care. The study team will collect clinical information about treatment response, timing of next treatments or death, and adverse events of special interest (for example cytokine release syndrome, infections, neurological events, hematologic toxicity), as well as microbiology and antibiotic-resistance data; these outcomes are followed from treatment start and may be assessed for up to ten years. The registry record does not specify additional experimental procedures beyond collecting data from routine care.
How the study is structured. A prospective observational cohort study. People who start specified immunotherapies as part of their regular care are followed over time; researchers collect clinical outcomes, adverse event data, and microbiology information without assigning or changing treatments. Many outcomes are followed for up to ten years.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Norway. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on AL amyloidosis
Important dates
- Study start
- Jan 15, 2025
- Primary completion
- January 2029 (estimated)
- Study completion
- Dec 1, 2037 (estimated)
- Target enrollment
- 400 participants (estimated)
- Last updated on registry
- Mar 3, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- St. Olavs Hospital
- Collaborators
- Norwegian University of Science and Technology
- Haukeland University Hospital
- Helse Stavanger HF
- Oslo University Hospital
- University Hospital, Akershus
- Sykehuset i Vestfold Hospital Trust
- University Hospital of North Norway
- Ålesund Hospital, Norway
- Helse Nord-Trøndelag HF
- Sorlandet Hospital HF
- Førde Hospital Trust
- Molde Hospital
- Bodø Hospital, Norway
- Helse Fonna
- Volda Hospital
- Diakonhjemmet Hospital
- Telemark Hospital Trust
- Kristiansund Hospital
- Vestre Viken Hospital Trust
- Lovisenberg Diakonale Hospital
- Sykehuset Innlandet HF
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Tobias S Slørdahl, MD PhD 📞 +4772825100 ✉ tobias.s.slordahl@ntnu.no
- Juni S Paulsen, MD 📞 +4772825100 ✉ juni.paulsen@ntnu.no
Participating sites (23)
- Sørlandet Hospital - ArendalNot Yet Recruiting
Arendal · Norway
- Silje Beate Holck-Steen, MD · +47 38 07 30 00 · silbel@sshf.no
- Ålesund hospital, Department of hematologyNot Yet Recruiting
Ålesund · Norway
- Eivind Samstad, MD PhD · +47 70 10 50 00 · eivind.samstad@ntnu.no
- Haukeland University HospitalNot Yet Recruiting
Bergen · Norway
- Galina Tsykunova, MD · +47 55 97 37 00 · galina.tsykunova@helse-bergen.no
- Bodø HospitalNot Yet Recruiting
Bodø · Norway
- Terje Solhaug, MD · +47 75 53 40 00 · Terje.Singsaas.Solhaug@nordlandssykehuset.no
- Bærum HospitalNot Yet Recruiting
Bærum · Norway
- Hanne Kristin Fredly, MD · +47 32 80 30 30 · Hanne.Kristin.Fredly@vestreviken.no
- Drammen hospitalNot Yet Recruiting
Drammen · Norway
- Anne Elisabeth Tónay, MD · +47 32 80 30 30 · antona@vestreviken.no
- Førde hospitalNot Yet Recruiting
Førde · Norway
- Damian Szatkowski, MD · +47 57 83 90 00 · damian.lukasz.szatkowski@helse-forde.no
- Innlandet hospital trustNot Yet Recruiting
Gjøvik · Norway
- Kristoffer Winje, MD · +47 915 06 200 · Kristoffer.Winje.Hagen@sykehuset-innlandet.no
- Haugesund hospitalNot Yet Recruiting
Haugesund · Norway
- Camilla S Bjørnsen, MD PhD · +47 52 73 90 00 · camilla.stapnes.bjornsen@helse-fonna.no
- Sørlandet hospitalNot Yet Recruiting
Kristiansand · Norway
- Hedda Lerdal, MD · +47 38 07 30 00 · hedda.lerdal@sshf.no
Terms used on this page · explanations by MedicalUpdates.ai
- adverse events
- Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
- Inclusion criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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