Study of REVLIMID (Lenalidomide) Versus Placebo in Patients With Low Risk Myelodysplastic Syndrome (SINTRA-REV)
This clinical trial is a phase III multicenter, randomized, double blind and controlled with placebo trial and with two arms designed to assess the efficiency and toxicity of the scheme Lenalidomide versus observation in a series of 60 patients with low risk myelodysplastic syndrome associated to 5q deletion with anemia (Hb≤12g/dL) but without the need of transfusion. Patients are randomized in the study in a 2:1 ratio. They will receive treatment for 104 weeks until progression of the disease, which implies that the patient suffering from anemia due to myelodysplastic syndrome requires transfusion of at least 2 UCH/56 days (2 months) with a minimum follow up of 112 days (4 months), or unacceptable toxicity.
Low risk myelodysplastic syndrome associated to the loss of 5q without transfusion requirements.
Total number of patients:
In total 60 patients will be included, 40 assigned to the treatment branch and 20 to the placebo branch.
First patient first visit: February 2010, and Last patient last visit expected in February 2016. (Recruitment was initially expected to take place over a period of 24 months and was expected to be finished in February 2012, but due to low rate of recruitment it was extended until the population sample is included in the trial).
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Multicenter, Randomized, Double-blind, Phase III Study of REVLIMID (Lenalidomide) Versus Placebo in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 IPSS) With Alteration in 5q- and Anemia Without the Need of Transfusion.|
- Period until the progression of myelodysplastic syndrome [ Time Frame: 6 years (study treatment and follow up) ]To assess if treatment with Revlimid (Lenalidomide) extends the period until the progression to MDS of(5q) considered as transfusion independent, documented verification that the patient suffering from anemia due to MDS requires transfusion of at least 2 UCH/56 days (2 months) with a minimum follow up of 112 days (4 months). Revlimid will be compared to the current standard treatment for patients with low risk MDS associated with the loss of 5q without transfusion dependent anemia, which is the therapeutic abstention and monitoring until its progression.
- Safety [ Time Frame: 6 years (study treatment and follow up) ]Safety (type, frequency and severity [Criteria of normal terminology of adverse reactions of the National Cancer Institute (NCI CTCAE) version 3.0] of adverse reactions (AR)and list of the AR with Lenalidomide.
- Erythroid response [ Time Frame: 6 years (study treatment and follow up) ]Erythroid response according to the Criteria of the MDS International Work Team.
- Duration of the red blood cells transfusion independency [ Time Frame: 6 years (study treatment and follow up) ]Red blood cells transfusion independency,defined as the number of days elapsed between the randomization and the first transfusion after this period free of transfusions.
- Change of the hemoglobin concentration (Hb) in relation to baseline levels [ Time Frame: 6 years (study treatment and follow up) ]Change of the hemoglobin concentration (Hb) in relation to baseline levels of patients who show erythroid response.
- Variation in platelets and neutrophils absolute count in relation to baseline levels [ Time Frame: 6 years (study treatment and follow up) ]
- Cytogenetic response [ Time Frame: 6 years (study treatment and follow up) ]Cytogenetic response according to the Criteria of the MDS International Work Team.
- Bone marrow response [ Time Frame: 6 years (study treatment and follow up) ]Bone marrow response according to the Criteria of the MDS International Work Team.
- Global survival, Event Free Survival and Rate of Transformation to Acute Leukemia. [ Time Frame: 6 years (study treatment and follow up) ]
- Time from diagnose to transfusion independence. [ Time Frame: 6 years (study treatment and follow up) ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||January 2022|
|Estimated Primary Completion Date:||September 2021 (Final data collection date for primary outcome measure)|
Experimental treatment branch with Lenalidomide 5 mg/day (oral use)
Treatment with Revlimid (lenalidomide), oral use, 5 mg daily during study treatment (104 weeks).
Other Name: Revlimid 5 mg
Placebo Comparator: placebo
Placebo branch (oral use)
Placebo, oral use, daily during study treatment (104 weeks)
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243476
|Hospital de Cabueñes||Terminated|
|Gijón, Asturias, Spain, 33394|
|Hospital Central de Asturias||Recruiting|
|Oviedo, Asturias, Spain, 33006|
|Contact: Teresa Bernal del Castillo, MD 0034 985 108 000 ext 39179 firstname.lastname@example.org|
|Principal Investigator: Teresa Bernal del Castillo, MD|
|Hospital Universitari Germans Trias i Pujol (ICO Badalona)||Recruiting|
|Badalona, Barcelona, Spain, 08916|
|Contact: Blanca Xicoy Cirici, MD 0034 93 497 89 24 email@example.com|
|Principal Investigator: Blanca Xicoy Cirici, MD|
|Hospital Son Llàtzer||Recruiting|
|Palma de Mallorca, Islas Baleares, Spain, 07198|
|Contact: Joan Bargay Lleonart, MD 0034 871 20 21 38 firstname.lastname@example.org|
|Principal Investigator: Joan Bargay Lleonart, MD|
|Hospital de Cruces||Recruiting|
|Barakaldo, Vizcaya, Spain, 48930|
|Contact: Beatriz Arrizabalaga Amuchastegui, MD 0034 946 00 60 89 BEATRIZ.ARRIZABALAGAAMUCHASTEG@osakidetza.net|
|Principal Investigator: Beatriz Arrizabalaga Amuchastegui, MD|
|Hospital Clínic i Provincial||Recruiting|
|Barcelona, Spain, 08036|
|Contact: Benet Nomdedeu Tobella, MD 0034 93 227 54 00 ext 2805 email@example.com|
|Principal Investigator: Benet Nomdedeu Tobella, MD|
|Hospital Universitario Reina Sofía||Recruiting|
|Córdoba, Spain, 14004|
|Contact: Joaquín Sánchez García, MD 0034 957 010 176 firstname.lastname@example.org|
|Principal Investigator: Joaquín Sánchez García, MD|
|Hospital Infanta Leonor||Recruiting|
|Madrid, Spain, 28031|
|Contact: José Angel Hernandez Rivas, MD 0034 911918507 email@example.com|
|Principal Investigator: José Angel Hernandez Rivas, MD|
|Hospital Clínico San Carlos||Terminated|
|Madrid, Spain, 28040|
|Hospital Universitario La Paz||Terminated|
|Madrid, Spain, 28046|
|Hospital General Universitario José Maria Morales Meseguer||Recruiting|
|Murcia, Spain, 30008|
|Contact: Maria Luz Amigo Lozano, MD 0034 968 36 09 00 firstname.lastname@example.org|
|Principal Investigator: Mª Luz Amigo Lozano, MD|
|Hospital Clínico Universitario de Salamanca||Recruiting|
|Salamanca, Spain, 37007|
|Contact: María Díez Campelo, MD 0034 923 29 13 16 email@example.com|
|Principal Investigator: María Díez Campelo, MD|
|Hospital Universitario Virgen del Rocío||Terminated|
|Sevilla, Spain, 41013|
|Hospital Universitario La Fe||Recruiting|
|Valencia, Spain, 46009|
|Contact: Guillermo Sanz Santillana, MD 0034 96 386 27 09 firstname.lastname@example.org|
|Principal Investigator: Guillermo Sanz Santillana, MD|
|Study Chair:||Consuelo del Cañizo, MD||Hospital Clínico Universitario de Salamanca|
|Study Chair:||María Díez Campelo, MD||Hospital Clínico Universitario de Salamanca|