A Study of the First-line Treatment of Patients With Newly Diagnosed Transplant-ineligible Multiple Myeloma in Spain

NCT ID: NCT03602755

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 706 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-19
• Study Completion Date: 2019-01-18

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.

Conditions

Multiple Myeloma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with newly diagnosed transplant-ineligible MM

Adult Patients with newly diagnosed MM who were not suitable candidates for ASCT who started first-line treatment for the study disease in a routine clinical practice setting between 2012 and 2016, inclusive.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giselle Lostaunau, MD

Role: STUDY_DIRECTOR

Celgene

Locations

H. Santiago (CHUS)

Santiago de Compostela, A Coruña, Spain

H. Txagorritxu

Vitoria-Gasteiz, Alava, Spain

H. Son Espases

Palma, Balearic Islands, Spain

ICO Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, Spain

H. Althaia

Manresa, Barcelona, Spain

H. Mutua de Terrassa

Terrassa, Barcelona, Spain

H. Jerez

Jerez de la Frontera, Cadiz, Spain

H. Alvaro Cunqueiro

Vigo, Pontevedra, Spain

H. Cabueñes

Gijón, Principality of Asturias, Spain

H. Central de Asturias

Oviedo, Principality of Asturias, Spain

H. del Mar

Barcelona, , Spain

H. Josep Trueta

Girona, , Spain

H. Arnau de Villanova

Lleida, , Spain

H- Virgen de la Victoria

Málaga, , Spain

H. Carlos Haya

Málaga, , Spain

H. Ourense (CHOU)

Ourense, , Spain

H. Virgen Macarena

Seville, , Spain

H. Joan XXIII

Tarragona, , Spain

H. Dr. Peset

Valencia, , Spain

H. La Fe

Valencia, , Spain

Countries

Spain

Other Identifiers

U1111-1215-4398

Identifier Type: OTHER

Identifier Source: secondary_id

NDS-MM-002

Identifier Type: -

Identifier Source: org_study_id