The Norwegian Immunotherapy in Multiple Myeloma Study

Recruiting

• Conditions: Myeloma Multiple; Plasma Cell Leukemia; AL Amyloidosis

• Registration Number: NCT06855121
• Lead Sponsor: St. Olavs Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-15
• Study First Submitted: 2025-01-24
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03
• Primary Completion: 2029-01
• Study Completion: 2037-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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)
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.

Trial Locations

Locations (23)

Sørlandet hospital; 🇳🇴 Kristiansand, Norway

Bærum Hospital; 🇳🇴 Bærum, Norway

Sørlandet Hospital - Arendal; 🇳🇴 Arendal, Norway

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Bodø Hospital; 🇳🇴 Bodø, Norway

Drammen hospital; 🇳🇴 Drammen, Norway

Førde hospital; 🇳🇴 Førde, Norway

Innlandet hospital trust; 🇳🇴 Gjøvik, Norway

Haugesund hospital; 🇳🇴 Haugesund, Norway

Nordmøre and Romsdal Hospital - Kristiansund; 🇳🇴 Kristiansund, Norway

Levanger hospital; 🇳🇴 Levanger, Norway

Nordmøre and Romsdal Hospital - Molde; 🇳🇴 Molde, Norway

Akershus University Hospital (AHUS); 🇳🇴 Nordbyhagen, Norway

Diakonhjemmet hospital; 🇳🇴 Oslo, Norway

Lovisenberg Diaconal Hospital; 🇳🇴 Oslo, Norway

Oslo Myeloma Center, Oslo University Hospital; 🇳🇴 Oslo, Norway

Telemark Hospital Trust; 🇳🇴 Skien, Norway

Stavanger University hospital; 🇳🇴 Stavanger, Norway

University hospital of North Norway; 🇳🇴 Tromsø, Norway

St. Olavs hospital HF; 🇳🇴 Trondheim, Norway

Vestfold Hospital Trust; 🇳🇴 Tønsberg, Norway

Volda hospital; 🇳🇴 Volda, Norway

Ålesund hospital, Department of hematology; 🇳🇴 Ålesund, Norway