Myeloma Multiple, Plasma Cell Leukemia, AL Amyloidosis
Conditions
Keywords
bispesific antibodies, teclistamab, elranatamab, talquetamab, cilta-cel, ide-cel, ciltacabtagene autoleucel, idecabtagene vicleucel, CRS, ICAN, infections, supportive care
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.
Interventions
DRUGTeclistamab
Real-world use and dosing
DRUGElranatamab
Real-world use and dosing
BIOLOGICALCiltacabtagene Autoleucel
Real-world use.
DRUGTalquetamab
Real-world use and dosing
BIOLOGICALIdecabtagene vicleucel
Real-world use and dosing
Sponsors
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
St. Olavs Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
Countries
Norway
Contacts
Primary ContactTobias S Slørdahl, MD PhD
Backup ContactJuni S Paulsen, MD
Outcome results
None listed