DARWIN EU® Multiple myeloma: patient characterisation, treatments and survival in the period 2012-2022

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Disease epidemiology
• 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:
  100000096036

  dexamethasone

  100000096041

  prednisone

  100000096617

  cyclophosphamide

  100000096619

  melphalan

  100000116251

  bendamustine

  100000096674

  vincristine

  100000096678

  etoposide

  100000096692

  doxorubicin

  100000096708

  cisplatin

  100000170636

  elotuzumab

  200000003285

  daratumumab

  200000012517

  isatuximab

  200000016136

  carfilzomib

  200000016137

  ixazomib

  200000028541

  brexucabtagene autoleucel

  200000030589

  idecabtagene vicleucel

  200000041609

  lisocabtagene maraleucel

  100000096761

  bortezomib

  100000173048

  venetoclax

  200000012111

  selinexor

  200000016155

  axicabtagene ciloleucel

  200000016156

  tisagenlecleucel

  100000096883

  thalidomide

  100000096885

  lenalidomide

  100000157885

  pomalidomide

  100000097109

  clodronic acid

  100000097110

  pamidronic acid

  100000097113

  ibandronic acid

  100000097115

  zoledronic acid

  100000116261

  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

Results tables

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

Study, other information

Study Protocol P2 C1-001 Version 3.1 final