NCT03602755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
706

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

July 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2019

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

June 26, 2018

Last Update Submit

January 31, 2019

Conditions

Multiple Myeloma

Keywords

TransplantMultiple MyelomaSpain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Description of the characteristics of patients with a diagnosis of MM who were not candidates for ASCT in Spain

    Up to approximately 5 months

  • Description of the characteristics of patients with a diagnosis of MM who were not candidates for ASCT in Spain

    Up to approximately 5 months

  • Progression-free survival (PFS)

    Up to approximately 5 months

  • Overall survival (OS)

    Up to approximately 5 months

  • Overall response rate

    Up to approximately 5 months

  • +4 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

H. Santiago (CHUS)

Santiago de Compostela, A Coruña, 15706, Spain

Location

H. Txagorritxu

Vitoria-Gasteiz, Alava, 01009, Spain

Location

H. Son Espases

Palma, Balearic Islands, 07120, Spain

Location

ICO Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

H. Althaia

Manresa, Barcelona, 08243, Spain

Location

H. Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

H. Jerez

Jerez de la Frontera, Cadiz, 11408, Spain

Location

H. Alvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

Location

H. Cabueñes

Gijón, Principality of Asturias, 33394, Spain

Location

H. Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

H. del Mar

Barcelona, 0 8003, Spain

Location

H. Josep Trueta

Girona, 17007, Spain

Location

H. Arnau de Villanova

Lleida, 25198, Spain

Location

H- Virgen de la Victoria

Málaga, 29010, Spain

Location

H. Carlos Haya

Málaga, 29010, Spain

Location

H. Ourense (CHOU)

Ourense, 32005, Spain

Location

H. Virgen Macarena

Seville, 41009, Spain

Location

H. Joan XXIII

Tarragona, 43005, Spain

Location

H. Dr. Peset

Valencia, 46017, Spain

Location

H. La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Giselle Lostaunau, MD

    Celgene

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 27, 2018

Study Start

July 19, 2018

Primary Completion

January 18, 2019

Study Completion

January 18, 2019

Last Updated

February 4, 2019

Record last verified: 2019-01

Locations

ES(20)