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

Multiple Myeloma Clinical Trial

— RETRO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03602755
• Other study ID #: NDS-MM-002
• Secondary ID: U1111-1215-4398
• Status: Completed
• Start date: July 19, 2018
• Est. completion date: January 18, 2019

Study information

• Verified date: January 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 706
• Est. completion date: January 18, 2019
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
Spain	H. del Mar	Barcelona
Spain	H. Cabueñes	Gijón	Asturias
Spain	H. Josep Trueta	Girona
Spain	H. Jerez	Jerez de la Frontera	Cadiz
Spain	ICO Duran i Reynals	L'Hospitalet de Llobregat	Barcelona
Spain	H. Arnau de Villanova	Lleida
Spain	H- Virgen de la Victoria	Malaga
Spain	H. Carlos Haya	Malaga
Spain	H. Althaia	Manresa	Barcelona
Spain	H. Ourense (CHOU)	Orense
Spain	H. Central de Asturias	Oviedo	Asturias
Spain	H. Son Espases	Palma	Baleares
Spain	H. Santiago (CHUS)	Santiago de Compostela	A Coruña
Spain	H. Virgen Macarena	Sevilla
Spain	H. Joan XXIII	Tarragona
Spain	H. Mutua de Terrassa	Terrasa	Barcelona
Spain	H. Dr. Peset	Valencia
Spain	H. La Fe	Valencia
Spain	H. Alvaro Cunqueiro	Vigo	Pontevedra
Spain	H. Txagorritxu	Vitoria	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of the first-line treatment regimens	Number of patients in the different first-line treatment regimens, in terms of the main drug used in patients diagnosed de novo with MM who were not candidates for autologous stem cell transplantation (ASCT)	Up to approximately 5 months
Secondary	Description of the characteristics of patients with a diagnosis of MM who were not candidates for ASCT in Spain	Number of patients with a diagnosis of MM who were not candidates for ASCT in Spain in each staging group: Stage I, II and III (ISS) and ISS R	Up to approximately 5 months
Secondary	Description of the characteristics of patients with a diagnosis of MM who were not candidates for ASCT in Spain	Number of patients with a diagnosis of MM who were not candidates for ASCT in Spain in each MM subtype group	Up to approximately 5 months
Secondary	Progression-free survival (PFS)	Is described as time from start of treatment until disease progression or death	Up to approximately 5 months
Secondary	Overall survival (OS)	Is described as time from start of the treatment until death	Up to approximately 5 months
Secondary	Overall response rate	Is based on IMWG criteria	Up to approximately 5 months
Secondary	Duration of response	Is described as time from start of the treatment until end of first line treatment	Up to approximately 5 months
Secondary	Patients who receive second-line treatment	Proportion of patients who receive second-line treatment	Up to approximately 5 months
Secondary	Patients who underwent dose adjustment or switched treatment	Proportion of patients who underwent dose adjustment or switched treatment	Up to approximately 5 months
Secondary	Patients who discontinued treatment	Proportion of patients who discontinued treatment	Up to approximately 5 months