Health Outcomes of Recently Diagnosed Myelodysplastic Syndrome (MDS)/Chronic Myelomonocytic Leukemia (CMML) Patients Depending on Treatment Strategy (Wait and See, Support, Active Treatment)
Post-authorization, Observational Study to Assess the Evolution in the Normal Clinical Practise of Patients With Recent Diagnosis of Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML), Depending on the Time of Active Treatment Initiated
1 other identifier
observational
503
1 country
50
Brief Summary
Post-authorisation observational study to assess the evolution in normal clinical practice of patients recently diagnosed with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukaemia (CMML), depending on the moment when active treatment is initiated. Subjects will be recruited from approximately 50 haematology sites in Spain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2012
Longer than P75 for all trials
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 17, 2012
CompletedFirst Submitted
Initial submission to the registry
March 7, 2014
CompletedFirst Posted
Study publicly available on registry
March 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2018
CompletedJanuary 27, 2020
January 1, 2020
2.7 years
March 7, 2014
January 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event Free Survival
Period of time elapsed between diagnosis of the condition (MDS or CMML) and the appearance of one of an event: Progression of the disease, death (all causes), clinically significant condition requiring a change in initial therapeutic strategy, adverse event requiring treatment discontinuation
Up to a minimum of 36 months' follow-up from the start of active treatment
Secondary Outcomes (5)
Health Assesment/performance Status
Approximately 3 years
Response to active treatment
Up to end of treatment for each patient
Patient evolution based on time-dependent response parameters
Approximately 3 years
Adverse Events
Approximately 3 years
Patient Description
Baseline
Study Arms (3)
Group 1
Low or intermediate-1 risk MDS patients according to IPSS
Group 2
Intermediate-2 risk MDS patients according to IPSS
Group 3
Any risk CMML patients according to CPSS
Interventions
As described above
Eligibility Criteria
Patients recently diagnosed (within the last 3 months prior to entering the study) of SMD or CMML, naïve to active treatment.
You may qualify if:
- Male or female subjects, aged 18 years or older. 2. Subjects with documented diagose of MDS or CMML within the last 3 months prior to entering the study and naive to treatment.
- \. Signed informed consent.
You may not qualify if:
- \. Subjects participating in an interventional clinical trial 2. Subjects who do not agree to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (50)
Hospital Universitario Txagorritxu
Vitoria-Gasteiz, Alava, 01009, Spain
Hospital Universitario La Ribera
Alzira, Alicante, 46600, Spain
Hospital Universitari Germans Trias I Pujol
Badalona, Barcelona, 08916, Spain
Complejo Hospitalrio La Mancha Centro
Alcázar de San Juan, Ciudad Real, 13600, Spain
Hospital Punta de Europa
Algeciras, Cádiz, 11207, Spain
Hospital Universitario Donostia
San Sebastián, Guipuzcoa, 20008, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922, Spain
Hospital Universitario Getafe
Getafe, Madrid, 28905, Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
Hospital de Antequera
Hospital de Antequera, Málaga, 29200, Spain
Hospital Costa del Sol
Marbella, Málaga, 29603, Spain
Hospital Nuestra Señora del Prado
Talavera de la Reina, Toledo, 45600, Spain
Complejo Hospitalario Torrecárdenas
Almería, 29010, Spain
Parc de Salut Mar- Hospital del Mar
Barcelona, 08003, Spain
Hospital de la Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital Duran Reynals
Barcelona, 08907, Spain
Hospital Universitario Puerta del Mar
Cadiz, 11009, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Hospital Universitari de Girona Josep Trueta
Girona, 17007, Spain
Hospital Can Misses
Ibiza Town, 07800, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, 35010, Spain
CHU-Insular
Las Palmas de Gran Canaria, 35016, Spain
Hospital de León
León, 24071, Spain
Hospital Lucus Augusti
Lugo, 27003, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Fundación Jimenez Díaz
Madrid, 28040, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital General Universitario Santa Lucía
Murcia, 30202, Spain
Complejo Universitario Hospitalario de Ourense
Ourense, 32005, Spain
Hospital Universitario Central de Asturias
Oviedo, 33006, Spain
Hospital Son Llàtzer
Palma de Mallorca, 07198, Spain
Complejo Hospitalrio Universitario de Pontevedra
Pontevedra, 36002, Spain
Hospital Universitario Salamanca
Salamanca, 37007, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, 15706, Spain
Hospital General de Segovia
Segovia, 40002, Spain
Hospital de Valme
Seville, 41014, Spain
Hospital Universitario Virgen Macarena
Seville, 41071, Spain
Hospital Santa Bárbara
Soria, 42005, Spain
Hospital Clínico Universitario Valencia
Valencia, 46010, Spain
Hospital Arnau de Vilanova
Valencia, 46015, Spain
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
Hospital Universitario La Fe
Valencia, 46026, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, 47005, Spain
Hospital Universitario Río Hortega
Valladolid, 47012, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Montserrat Rafel, RML Advocacy
Celgene Spain
- PRINCIPAL INVESTIGATOR
Regina Garcia, MD
Hospital Clínico Virgen de la Victoria, Málaga, Spain
- PRINCIPAL INVESTIGATOR
David Valcárcel, MD
Hospital Vall d'Hebron, Barcelona, Spain
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2014
First Posted
March 13, 2014
Study Start
December 17, 2012
Primary Completion
August 31, 2015
Study Completion
December 14, 2018
Last Updated
January 27, 2020
Record last verified: 2020-01