Study Stopped
Bias in the study
Post-authorisation Study of Biological Relapse in Patients With Multiple Myeloma
EPA-MMBR
Post-authorisation Observational Registry to Assess the Clinical Impact of Initiating Anti-tumour Rescue Therapy in Patients With Multiple Myeloma (MM) in Asymptomatic Biological Relapse Compared to Initiating Treatment at the Time of Symptomatic Relapse.
1 other identifier
observational
415
1 country
44
Brief Summary
Post-authorisation prospective follow-up study to assess the clinical impact on time to progression (TTP) from the start of anti- multiple myeloma treatment at the onset of asymptomatic relapse/biological progression versus start of treatment at the time of symptomatic relapse.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2013
Longer than P75 for all trials
44 active sites
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
Study Start
First participant enrolled
May 14, 2013
CompletedFirst Submitted
Initial submission to the registry
March 16, 2015
CompletedFirst Posted
Study publicly available on registry
March 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2021
CompletedSeptember 14, 2021
August 1, 2021
8 years
March 16, 2015
September 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to progression (TTP)
The period from when relapse/biological progression is detected until a new relapse or progression of tumour to the treatment received for biological or clinical relapse is documented according to the criteria of the IMW Consensus Panel.
Up to 38 months
Secondary Outcomes (19)
Race of participants at Baseline
Baseline visit
Age of participants at Baseline
Baseline visit
Gender of participants at Baseline
Baseline visit
Stage of Multiple Myeloma (MM) before study entry based on the international staging system (ISS)
Baseline visit
Time from first pathologic diagnosis
Baseline visit
- +14 more secondary outcomes
Study Arms (2)
Group 1
Patients in relapse/biological progression (under the criteria of the IMW (International Myeloma Workshop) Consensus Panel 1 not receiving treatment until clinical relapse.
Group 2
Patients in relapse/biological progression receiving anti-MM treatment at the time of relapse/biological progression): Patients in this group may receive conventional anti-myeloma treatment as per routine clinical practice at the participating site: 1. Upon relapse/biological progression, defined as per the criteria of the IMW (International Myeloma Workshop) Consensus Panel Panel1 Or 2. Upon a significant relapse of paraprotein, defined as: * Duplication of M-component in two consecutive readings taken ≤2 months apart; or * An increase in absolute levels of serum M-protein ≥1 g/dL or M-protein in urine at ≥500 mg/24h, or * Increase in light chain levels ≥20 mg/dL with an abnormal ratio in two consecutive readings taken ≤2 months apart), which suggests the presence of biological progression/relapse criteria, but without including any clinical details of those involved in clinical relapse.
Eligibility Criteria
Patients with a diagnosis of MM having received first or second-line treatment who have achieved ≥PR since their last anti-MM treatment, so that patients may be included in the registry before relapse/biological progression while followed every 1 to 2 months based on routine clinical practice, as well as at the time relapse/biological progression is detected, as per the criteria of the IMW Consensus Panel 11.
You may qualify if:
- Male or female, greater than or equal to 18 years of age patients with a diagnosis of Multiple Myeloma (MM) based on the international criteria.
- Patients with a diagnosis of Multiple Myeloma who had not received more than two regimen therapies and who had achieved at least a Partial Response (PR) with the last anti- Multiple Myeloma treatment according the criteria of the IMW (International Myeloma Workshop) Consensus Panel 1, included before relapse/biological progression or with an asymptomatic relapse (without Calcium increase, Renal Impairment, Anemia and Bone Lesion (CRAB) symptoms) defined by a ≥25% increase on the lowest value obtained during remission, in any of the following:
- Serum M-protein (absolute increase must be ≥05 g/dL) and/or
- Urine M-component (absolute increase must be ≥ 200 Mg/24 hrs.), and/or
- Only for patients without measurable components in serum and urine, a 25% increase on the lowest difference in Free light chain (FLC) ratios (absolute increase \>10 mg/dL)
- Patients with an asymptomatic relapse/progression from a Complete Response (CR):
- Reappearance of serum or urine M-protein by immunofixation or electrophoresis
- Patients who consent in writing after they has clearly explained the nature and purpose of the study (consent written informed).
You may not qualify if:
- Patients who are participating in an interventional clinical trial.
- Patients that refuse to participate in the study.
- Patients who present physical or mental incapacity to understand the information that is supplied, and/or respond to questions their doctor will perform as part of the study.
- Clinical Relapse Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (44)
Hospital Miguel Servet
Zaragoza, Aragon, 50009, Spain
Hospital Royo Villanova
Zaragoza, Aragon, 50015, Spain
Hospital Son Espases
Palma de Mallorca, Balearic Islands, 07120, Spain
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 07120, Spain
Hospital de Donostia
Donostia / San Sebastian, Basque Country, 20014, Spain
Hospital Txagorritxu
Vitoria-Gasteiz, Basque Country, 01009, Spain
Hospital Universitario de Canarias
La Laguna. Santa Cruz de Tenerife, Canary Islands, 38320, Spain
Hospital de Gran Canaria, Dr. Negrín
Las Palmas de Gran Canaria, Canary Islands, 35010, Spain
Hospital Ntra. Sra. de la Candelaria
Santa Cruz de Tenerife, Canary Islands, 38010, Spain
Hospital Universitario de Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Nuestra Señora de Sonsoles Avila
Ávila, Castille and León, 05071, Spain
Hospital de Burgos
Burgos, Castille and León, 09007, Spain
Hospital de León
León, Castille and León, 24001, Spain
Hospital de Segovia
Segovia, Castille and León, 40003, Spain
Clínico Universitario de Valladolid
Valladolid, Castille and León, 47003, Spain
Hospital del Mar
Barcelona, Catalonia, 08003, Spain
Hospital Vall d´Hebron
Barcelona, Catalonia, 08035, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, Catalonia, 08208, Spain
Hospital Universitario Josep Trueta de Girona
Girona, Catalonia, 17007, Spain
Hospital Arnau de Vilanova de Lleida
Lleida, Catalonia, 25198, Spain
Hospital de Sabadell ( Parc Taulí)
Sabadell, Catalonia, 08208, Spain
Complejo Hospitalario de Cáceres (S. Pedro de Alcántara)
Cáceres, Extremadura, 10003, Spain
Hospital de Llerena
Llerena, Badajoz, Extremadura, 06900, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, Galicia, 15006, Spain
Complexo Hospitalario de Ourense
Ourense, Galicia, 32005, Spain
Hospital Montecelo
Pontevedra, Galicia, 36071, Spain
Complejo Hospitalario Universitario de Vigo
Vigo, Galicia, 36036, Spain
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, 28805, Spain
Hospital Universitario de Getafe
Getafe, Madrid, 28907, Spain
Hospital Quirón
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Infanta Sofía
San Sebastián de los Reyes, Madrid, 28702, Spain
Hospital Santa Lucía
Cartagena, Murcia, 30202, Spain
Hospital Virgen de Arrixaca
El Palmar, Murcia, Murcia, 30120, Spain
Hospital de Navarra
Pamplona, Navarre, 31008, Spain
Hospital de Cabueñes
Gijón, Principality of Asturias, 33394, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33006, Spain
Hospital General de Castellon
Catellón, Valencia, 12002, Spain
Hospital Clínico Universitario Valencia
Valencia, Valencia, 46010, Spain
Hospital Arnau de Vilanova (Valencia)
Valencia, Valencia, 46015, Spain
Hospital de Manises
Valencia, Valencia, 46940, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Infanta Leonor
Madrid, 28031, Spain
Complejo Universitario de San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mireya Navarro, MD
Celgene
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2015
First Posted
March 20, 2015
Study Start
May 14, 2013
Primary Completion
May 18, 2021
Study Completion
May 18, 2021
Last Updated
September 14, 2021
Record last verified: 2021-08