The Norwegian Immunotherapy in Multiple Myeloma Study (NIMMS)

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: AL Amyloidosis; Plasma Cell Leukemia; Myeloma Multiple
• Intervention / Treatment: Drug: Teclistamab; Drug: Elranatamab; Biological: Ciltacabtagene Autoleucel; Drug: Talquetamab; Biological: Idecabtagene vicleucel

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• 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

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• 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; 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; Stavanger University Hospital, Norway; Ålesund Hospital, Norway; Bodø Hospital, Norway; Førde Hospital Trust

Study record dates

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 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: infections; supportive care; CRS; elranatamab; ide-cel; idecabtagene vicleucel; teclistamab; bispesific antibodies; talquetamab; cilta-cel; ciltacabtagene autoleucel; ICAN
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Metabolic Diseases; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Leukemia; Proteostasis Deficiencies; Immunoglobulin Light-chain Amyloidosis; Multiple Myeloma; Neoplasms, Plasma Cell; Leukemia, Plasma Cell; Amyloidosis; Antineoplastic Agents, Immunological; Antineoplastic Agents; Idecabtagene vicleucel
• Other Study ID Numbers: NIMMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No