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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma

• Study Type: Observational
• Enrollment (Actual): 706

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 0 8003
    • H. del Mar
  • Girona, Spain, 17007
    • H. Josep Trueta
  • Lleida, Spain, 25198
    • H. Arnau de Villanova
  • Malaga, Spain, 29010
    • H- Virgen de la Victoria
  • Malaga, Spain, 29010
    • H. Carlos Haya
  • Orense, Spain, 32005
    • H. Ourense (CHOU)
  • Sevilla, Spain, 41009
    • H. Virgen Macarena
  • Tarragona, Spain, 43005
    • H. Joan XXIII
  • Valencia, Spain, 46017
    • H. Dr. Peset
  • Valencia, Spain, 46026
    • H. la Fé
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
      • H. Santiago (CHUS)
  • Alava
    • Vitoria, Alava, Spain, 01009
      • H. Txagorritxu
  • Asturias
    • Gijón, Asturias, Spain, 33394
      • H. Cabueñes
    • Oviedo, Asturias, Spain, 33011
      • H. Central de Asturias
  • Baleares
    • Palma, Baleares, Spain, 07120
      • H. Son Espases
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
      • ICO Duran i Reynals
    • Manresa, Barcelona, Spain, 08243
      • H. Althaia
    • Terrasa, Barcelona, Spain, 08221
      • H. Mutua de Terrassa
  • Cadiz
    • Jerez de la Frontera, Cadiz, Spain, 11408
      • H. Jerez
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • H. Álvaro Cunqueiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Progression-free survival (PFS)	Is described as time from start of treatment until disease progression or death	Up to approximately 5 months
Overall survival (OS)	Is described as time from start of the treatment until death	Up to approximately 5 months
Overall response rate	Is based on IMWG criteria	Up to approximately 5 months
Duration of response	Is described as time from start of the treatment until end of first line treatment	Up to approximately 5 months
Patients who receive second-line treatment	Proportion of patients who receive second-line treatment	Up to approximately 5 months
Patients who underwent dose adjustment or switched treatment	Proportion of patients who underwent dose adjustment or switched treatment	Up to approximately 5 months
Patients who discontinued treatment	Proportion of patients who discontinued treatment	Up to approximately 5 months

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Giselle Lostaunau, MD, Celgene

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2018
• Primary Completion (Actual): January 18, 2019
• Study Completion (Actual): January 18, 2019

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Transplant; Spain
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: NDS-MM-002; U1111-1215-4398 (Other Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No