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

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT03602755
• Lead Sponsor: Celgene

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-07-18
• Study Start: 2018-07-19
• Study First Posted: 2018-07-27
• Status Verified: 2019-01
• Primary Completion: 2019-01-18
• Study Completion: 2019-01-18
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 706

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of the first-line treatment regimens	Up to approximately 5 months	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)

Secondary Outcome Measures

Name	Time	Method
Overall response rate	Up to approximately 5 months	Is based on IMWG criteria
Duration of response	Up to approximately 5 months	Is described as time from start of the treatment until end of first line treatment
Patients who underwent dose adjustment or switched treatment	Up to approximately 5 months	Proportion of patients who underwent dose adjustment or switched treatment
Overall survival (OS)	Up to approximately 5 months	Is described as time from start of the treatment until death
Patients who discontinued treatment	Up to approximately 5 months	Proportion of patients who discontinued treatment
Description of the characteristics of patients with a diagnosis of MM who were not candidates for ASCT in Spain	Up to approximately 5 months	Number of patients with a diagnosis of MM who were not candidates for ASCT in Spain in each MM subtype group
Progression-free survival (PFS)	Up to approximately 5 months	Is described as time from start of treatment until disease progression or death
Patients who receive second-line treatment	Up to approximately 5 months	Proportion of patients who receive second-line treatment

Trial Locations

Locations (20)

H. Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

H. Cabueñes; 🇪🇸 Gijón, Asturias, Spain

H. Althaia; 🇪🇸 Manresa, Barcelona, Spain

ICO Duran i Reynals; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

H. Santiago (CHUS); 🇪🇸 Santiago de Compostela, A Coruña, Spain

H. Alvaro Cunqueiro; 🇪🇸 Vigo, Pontevedra, Spain

H. Son Espases; 🇪🇸 Palma, Baleares, Spain

H. Txagorritxu; 🇪🇸 Vitoria, Alava, Spain

H. Mutua de Terrassa; 🇪🇸 Terrasa, Barcelona, Spain

H. Jerez; 🇪🇸 Jerez de la Frontera, Cadiz, Spain

H. del Mar; 🇪🇸 Barcelona, Spain

H- Virgen de la Victoria; 🇪🇸 Malaga, Spain

H. Josep Trueta; 🇪🇸 Girona, Spain

H. Arnau de Villanova; 🇪🇸 Lleida, Spain

H. Carlos Haya; 🇪🇸 Malaga, Spain

H. La Fe; 🇪🇸 Valencia, Spain

H. Ourense (CHOU); 🇪🇸 Orense, Spain

H. Dr. Peset; 🇪🇸 Valencia, Spain

H. Virgen Macarena; 🇪🇸 Sevilla, Spain

H. Joan XXIII; 🇪🇸 Tarragona, Spain