Clinical trial NCT03602755: A Study of the First-line Treatment of Patients With Newly Diagnosed Transplant-ineligible Multiple Myeloma in Spain
Official title: Retrospective Study of the First-line Treatment of Patients With Newly Diagnosed Transplant-ineligible Multiple Myeloma Between 2012 and 2016, Treated According to Routine Clinical Practice in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Transplant
Multiple Myeloma
Spain
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 706
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In total, 400 patients with a de novo diagnosis of multiple myeloma who were not suitable candidates for ASCT who started anti-myeloma treatment between 2012 and 2016, inclusive, in a routine clinical practice setting in Spain, will be included.

Brief summary: This is an observational, post-authorization, retrospective, multicenter study (PAS-OD) that will be conducted in approximately 20 centers in Spain. In all cases, only data recorded prior to the date of study start will be collected to ensure its retrospective nature, thus reflecting real clinical practice, avoiding any influence on the physician's clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 18 years
* Patients with newly diagnosed MM who were not suitable candidates for ASCT who started anti-myeloma treatment between 2012 and 2016, inclusive.
* Patients who give informed consent before data collection begins.

Exclusion Criteria:

* Patients who participated in a clinical trial for first-line treatment of MM during the study period.
* Patients who are alive, but do not give their IC.
* Patients with MM who did not receive treatment.

Primary outcomes:
measure: Description of the first-line treatment regimens
timeFrame: Up to approximately 5 months
Secondary outcomes:
measure: Description of the characteristics of patients with a diagnosis of MM who were not candidates for ASCT in Spain
timeFrame: Up to approximately 5 months
measure: Description of the characteristics of patients with a diagnosis of MM who were not candidates for ASCT in Spain
timeFrame: Up to approximately 5 months
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 5 months
measure: Overall survival (OS)
timeFrame: Up to approximately 5 months
measure: Overall response rate
timeFrame: Up to approximately 5 months
measure: Duration of response
timeFrame: Up to approximately 5 months
measure: Patients who receive second-line treatment
timeFrame: Up to approximately 5 months
measure: Patients who underwent dose adjustment or switched treatment
timeFrame: Up to approximately 5 months
measure: Patients who discontinued treatment
timeFrame: Up to approximately 5 months
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: H. Santiago (CHUS)
state: A Coruña
city: Vitoria
country: Spain
facility: H. Txagorritxu
state: Alava
city: Gijón
country: Spain
facility: H. Cabueñes
state: Asturias
city: Oviedo
country: Spain
facility: H. Central de Asturias
state: Asturias
city: Palma
country: Spain
facility: H. Son Espases
state: Baleares
city: L'Hospitalet de Llobregat
country: Spain
facility: ICO Duran i Reynals
state: Barcelona
city: Manresa
country: Spain
facility: H. Althaia
state: Barcelona
city: Terrasa
country: Spain
facility: H. Mutua de Terrassa
state: Barcelona
city: Jerez de la Frontera
country: Spain
facility: H. Jerez
state: Cadiz
city: Vigo
country: Spain
facility: H. Alvaro Cunqueiro
state: Pontevedra
city: Barcelona
country: Spain
facility: H. del Mar
city: Girona
country: Spain
facility: H. Josep Trueta
city: Lleida
country: Spain
facility: H. Arnau de Villanova
city: Malaga
country: Spain
facility: H- Virgen de la Victoria
city: Malaga
country: Spain
facility: H. Carlos Haya
city: Orense
country: Spain
facility: H. Ourense (CHOU)
city: Sevilla
country: Spain
facility: H. Virgen Macarena
city: Tarragona
country: Spain
facility: H. Joan XXIII
city: Valencia
country: Spain
facility: H. Dr. Peset
city: Valencia
country: Spain
facility: H. La Fe
Study officials:
affiliation: Celgene
name: Giselle Lostaunau, MD
role: STUDY_DIRECTOR
References: