Study type

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine, other

Etidronate (ATC code: M05BA01), Etidronate (ATC code: L01XH03)

Study drug International non-proprietary name (INN) or common name

AXICABTAGENE CILOLEUCEL
BORTEZOMIB
BREXUCABTAGENE AUTOLEUCEL
CARFILZOMIB
CISPLATIN
CYCLOPHOSPHAMIDE
DARATUMUMAB
DENOSUMAB
DEXAMETHASONE
ELOTUZUMAB
IDECABTAGENE VICLEUCEL
ISATUXIMAB
LENALIDOMIDE
LISOCABTAGENE MARALEUCEL
POMALIDOMIDE
SELINEXOR
THALIDOMIDE
TISAGENLECLEUCEL
VENETOCLAX
ZOLEDRONIC ACID

Anatomical Therapeutic Chemical (ATC) code

(H02AB02) dexamethasone
(H02AB07) prednisone
(L01AA01) cyclophosphamide
(L01AA03) melphalan
(L01AA09) bendamustine
(L01CA02) vincristine
(L01CB01) etoposide
(L01DB01) doxorubicin
(L01XA01) cisplatin
(L01XC23) elotuzumab
(L01XC24) daratumumab
(L01XC38) isatuximab
(L01XG02) carfilzomib
(L01XG03) ixazomib
(L01XL06) brexucabtagene autoleucel
(L01XL07) idecabtagene vicleucel
(L01XL08) lisocabtagene maraleucel
(L01XX32) bortezomib
(L01XX52) venetoclax
(L01XX66) selinexor
(L01XX70) axicabtagene ciloleucel
(L01XX71) tisagenlecleucel
(L04AX02) thalidomide
(L04AX04) lenalidomide
(L04AX06) pomalidomide
(M05BA02) clodronic acid
(M05BA03) pamidronic acid
(M05BA06) ibandronic acid
(M05BA08) zoledronic acid
(M05BX04) denosumab

Medical condition to be studied

Plasma cell myeloma
Plasmacytoma

Additional medical condition(s)

Amyloid light chain amyloidosis due to multiple myeloma, Asymptomatic multiple myeloma, Bone marrow: myeloma cells, Extramedullary plasmacytoma, Hypogammaglobulinemia due to multiple myeloma, IgA myeloma, IgD myeloma, IgG myeloma, Indolent multiple myeloma, Kappa light chain myeloma, Lambda light chain myeloma, Light chain myeloma, Light chain nephropathy due to multiple myeloma, Multiple myeloma, Multiple myeloma in remission, Multiple solitary plasmacytomas, Myeloma-associated amyloidosis, Myeloma kidney, Neuropathy due to multiple myeloma, Non-secretory myeloma, Osteoporosis co-occurrent and due to multiple myeloma, Osteosclerotic myeloma, Plasma cell leukemia, Plasma cell leukemia in relapse, Plasma cell leukemia in remission, Primary cutaneous plasmacytoma, Relapse multiple myeloma, Smoldering myeloma, Solitary osseous myeloma
Population studied

Age groups

Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

20000000
Study design details

Main study objective

To characterise patients with multiple myeloma(MM) diagnosed 2012-2022. Specific objectives are to describe demographic and clinical characteristics of patients with MM at the time of diagnosis, MM treatments and MM treatment sequences and to estimate survival of incident MM cases during the study.

Outcomes

Treatment/s initiated at index date, 1 to 30, 1 to 90 and/or 1 to 365 days post index date, and death.

Data analysis plan

Large-scale patient-level characterisation will be conducted. Age and sex at time of multiple myeloma diagnosis, medical history and medication use will be described. The number and % of patients receiving each of a pre-specified list of multiple myeloma treatments and treatment combinations will also be described. Additionally, treatment patterns and sequences over time will be described. Survival will be estimated as the probability of survival from any cause of death and will be reported using Kaplan-Meier plots. This analysis will be conducted only for databases with complete information on mortality. A minimum cell count of 5 will be used when reporting results, with any smaller counts obscured.
Documents
Study results

DARWIN_EU_D2.2.4_Study Report_P2-C1-001_Multiple_Myeloma_v3.0

English (4.08 MB - PDF)View document
Study, other information

Study Protocol P2 C1-001 Version 3.1 final

English (1.49 MB - PDF)View document