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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 400
- Locations
- 23
- Primary Endpoint
- Determine the real-world overall response rates (ORR)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
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.
Determine real-world progression-free survival (PFS)
Time Frame: 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)
Time Frame: From date of treatment start and until date of start of next treatment, assessed up to ten years.
Determine real-world overall survival (OS)
Time Frame: 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.
Time Frame: 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).
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: From enrollment and until end of treatment, assessed up to ten years.
Secondary Outcomes
No secondary outcomes reported