A Study to Assess Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine Clearance

NCT02849444 | Completed

• 1 other identifier: CEL-MIE-2012-01
• Study Type: observational
• Target: 326
• Locations: 1 country
• Sites: 40

Brief Summary

A prospective, multicentre, post-authorisation observational study. The objective of this study is assess the response of renal function in clinical practice to anti-multiple myeloma therapy in patients with relapsed MM and CrCl \<50 mL/min/1.73 m2.

Conditions

Multiple Myeloma

Keywords

renal function; Relapsed Multiple myeloma; anti-MM therapy

Outcome Measures

Primary Outcomes (4)

• Creatinine levels to determinates Renal function response

  Creatinine records from basal visit to last visit to determinates Creatinine clearance with the Cockcroft-Gault formula.

  Up to 12 months

• Age of participants at baseline to determinates Renal function response

  Patient Age record to determinates Creatinine clearance with the Cockcroft-Gault formula.

  Baseline visit

• Weight of participants at baseline to determinates Renal function response

  Patient weight recorded in each visit to determinates Creatinine clearance with the Cockcroft-Gault formula.

  Baseline visit

• Gender of participants at baseline to determinates Renal function response

  Patient gender recorded in basal visit to determinates Creatinine clearance with the Cockcroft-Gault formula.

  Baseline visit

Secondary Outcomes (12)

• Race of participants at Baseline

  Baseline visit

• Clinical Outcome of participants with Multiple Myeloma (MM) clinical description

  Up to 12 months

• Renal response rate assessment in clinical practice.

  Up to 12 months

• Time dependent Renal response rate assessment in clinical practice.

  Up to 12 months

• Type of Anti-myeloma therapeutic regimens.

  Up to 12 months

Study Arms (2)

Moderate kidney failure

30 ≤ CrCl \< 50 mL/min/1.73 m2

Other: Anti-myeloma treatment at physician discretion

Severe kidney failure

CrCl \< 30 mL/min/1.73 m2

Other: Anti-myeloma treatment at physician discretion

Interventions

Anti-myeloma treatment at physician discretion OTHER

non Interventional Study

Moderate kidney failure; Severe kidney failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with relapsed /refractorymultiple myeloma and with CrCl \<50 mL/min/1.73 m2, for whom the investigator decides to start a new line of anti-myeloma treatment as per normal clinical practice. The decision to prescribe treatment will be clearly disassociated from the decision to include the patient in the study.

You may qualify if:

• Patients of both genders, aged equal or more than 18 years.
• Patients with documented relapsed multiple myeloma according to International Myeloma Working Group ( IMWG) criteria.
• Patients with documented renal damage defined as creatinine clearance \<50 ml / min / 1.73 m2 (CrCl \<50ml / min / 1.73m2).
• Patients to whom the researcher decides to initiate anti-myeloma treatment for relapse with one or more agents according to clinical practice \*.
• Patients who consent in writing after it has been clearly explained to them the nature and purpose of the study (written informed consent).
• Subject with any of the following characteristics (at least one of the 2 following options must be Yes):
• Subjects who have not previously participated in the study

You may not qualify if:

• The decision to prescribe treatment will be clearly dissociated from the decision to include the patient in the study
• Clarification is provided as to the aim of the study, which is to encompass all relapse subcategories included in the International Myeloma Working Group consensus document published in 2006. Therefore, all patients with clinically relapsed multiple myeloma, who are in relapse following a complete response or in progression (including refractory cases) as defined in point 8.1 and in table 4 of the protocol, are considered eligible candidates for participation in the EPA-MIR 50 study, as long as they meet all the other criteria
• Patients who are participating in an interventional clinical trial \* or who refuse to participate in the study.
• Patients with CrCl \<50 ml / min / 1.73m2 due to a cause other than multiple myeloma properly documented at the discretion of the investigator \*.

Sponsors & Collaborators

• Celgene: lead

Study Sites (40)

Hospital Torrecárdenas

Almería, Andalusia, 04009, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, Andalusia, 11009, Spain

Location

Hospital Virgen de la Nieves

Granada, Andalusia, 18014, Spain

Location

Hospital Universitario Ciudad de Jaen

Jaén, Andalusia, 23007, Spain

Location

Hospital general de jeréz

Jerez de la Frontera, Andalusia, 11407, Spain

Location

Hospital Virgen de la macarena

Seville, Andalusia, 41071, Spain

Location

Hospital Miguel Servet

Zaragoza, Aragon, 50009, Spain

Location

Hospital Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Hospital de Insular de Gran Canaria

Las Palmas de Gran Canaria, Canary Islands, 35010, Spain

Location

Hospital de Basurto

Bilbao, Castille and León, 48013, Spain

Location

Hospital de Burgos

Burgos, Castille and León, 09007, Spain

Location

Hospital de León

León, Castille and León, 24001, Spain

Location

Rio Hortega de Valladolid

Valladolid, Castille and León, 47003, Spain

Location

Hospital General de Ciudad Real

Ciudad Real, Castille-La Mancha, 13005, Spain

Location

Hospital La Ribera

Alzira, Catalonia, 46600, Spain

Location

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

Location

Hospital Vall d´Hebron

Barcelona, Catalonia, 08035, Spain

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, Catalonia, 08208, Spain

Location

Hospital Duran reynls

Barcelona, Catalonia, 08907, Spain

Location

Hospital Universitario Josep Trueta de Girona

Girona, Catalonia, 17007, Spain

Location

Hospital Arnau de Vilanova de Lleida

Lleida, Catalonia, 25198, Spain

Location

Hospital Sant Joan de manresa

Manresa, Catalonia, 08243, Spain

Location

Hospital de Sabadell ( Parc Taulí)

Sabadell, Catalonia, 08208, Spain

Location

Hospital Mutua terrassa

Terrassa, Catalonia, 08221, Spain

Location

Complejo Hospitalario Universitario Santiago

Santiago de Compostela, Galicia, 15006, Spain

Location

Complejo Hospitalario Universitario de Vigo

Vigo, Galicia, 36036, Spain

Location

Hospital san pedro

Logroño, La Rioja, 26006, Spain

Location

Hospital Fundación de Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Santa Lucía

Cartagena, Murcia, 30202, Spain

Location

Hospital Virgen de Arrixaca

El Palmar, Murcia, Murcia, 30120, Spain

Location

Hospital de Cabueñes

Gijón, Principality of Asturias, 33394, Spain

Location

Hospital General de Alicante

Alicante, Valencia, 03010, Spain

Location

Hospital Clínico Universitario Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital La fe

Valencia, Valencia, 46026, Spain

Location

Hospital Gregorio marañon

Madrid, 28007, Spain

Location

Hospital Ramon y Cajal

Madrid, 28034, Spain

Location

Complejo Universitario de San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario La paz

Madrid, 28046, Spain

Location

Hospital Dr peset

Valencia, 46017, Spain

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mireya Navarro, MD

  Celgene Spain

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: July 29, 2016
• Study Start: September 23, 2012
• Primary Completion: December 23, 2019
• Study Completion: December 10, 2020
• Last Updated: August 16, 2021

Record last verified: 2021-08

Locations

ES (40)