The Norwegian Immunotherapy in Multiple Myeloma Study | NCT06855121

Status Module

Name	Class
Norwegian University of Science and Technology	OTHER
Haukeland University Hospital	OTHER
Helse Stavanger HF	OTHER_GOV
Oslo University Hospital

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

Arms/Interventions Module

Interventions

Name	Type	Description
Teclistamab	Drug	Real-world use and dosing
Elranatamab	Drug	Real-world use and dosing
Ciltacabtagene Autoleucel	Biological	Real-world use.
Talquetamab	Drug	Real-world use and dosing
Idecabtagene vicleucel	Biological	Real-world use and dosing

Outcomes Module

Primary Outcomes

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.

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Tobias S Slørdahl, MD PhD	Contact	+4772825100		tobias.s.slordahl@ntnu.no
Juni S Paulsen, MD	Contact	+4772825100		juni.paulsen@ntnu.no

Facility	Status	City	State	ZIP	Country	Contacts
Sørlandet Hospital - Arendal	Not yet recruiting	Arendal			Norway

IPD Sharing Statement Module

ID	Term
D009101	Multiple Myeloma
D007952	Leukemia, Plasma Cell
D000075363	Immunoglobulin Light-chain Amyloidosis
D007239	Infections

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D007938	Leukemia
D000686	Amyloidosis
D057165	Proteostasis Deficiencies
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
C000730985	talquetamab
C000715380	idecabtagene vicleucel