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A Study to Assess Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine Clearance (MIR50)

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ClinicalTrials.gov Identifier: NCT02849444
Recruitment Status : Active, not recruiting
First Posted : July 29, 2016
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

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.

Condition or disease Intervention/treatment
Multiple Myeloma Other: Anti-myeloma treatment at physician discretion

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 326 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-authorisation Observational Study for the Assessment of Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine Clearance <50 mL/Min/1.73 m2 (CrCl <50 mL/Min/1.73 m2)
Actual Study Start Date : September 23, 2012
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : March 1, 2020


Group/Cohort Intervention/treatment
Moderate kidney failure
30 ≤ CrCl < 50 mL/min/1.73 m2
Other: Anti-myeloma treatment at physician discretion
non Interventional Study

Severe kidney failure
CrCl < 30 mL/min/1.73 m2
Other: Anti-myeloma treatment at physician discretion
non Interventional Study




Primary Outcome Measures :
  1. Creatinine levels to determinates Renal function response [ Time Frame: Up to 12 months ]
    Creatinine records from basal visit to last visit to determinates Creatinine clearance with the Cockcroft-Gault formula.

  2. Age of participants at baseline to determinates Renal function response [ Time Frame: Baseline visit ]
    Patient Age record to determinates Creatinine clearance with the Cockcroft-Gault formula.

  3. Weight of participants at baseline to determinates Renal function response [ Time Frame: Baseline visit ]
    Patient weight recorded in each visit to determinates Creatinine clearance with the Cockcroft-Gault formula.

  4. Gender of participants at baseline to determinates Renal function response [ Time Frame: Baseline visit ]
    Patient gender recorded in basal visit to determinates Creatinine clearance with the Cockcroft-Gault formula.


Secondary Outcome Measures :
  1. Race of participants at Baseline [ Time Frame: Baseline visit ]
    To describe the demographic characteristics of patients with relapsed multiple myeloma and CrCl <50 mL/min/1.73 m2.

  2. Clinical Outcome of participants with Multiple Myeloma (MM) clinical description [ Time Frame: Up to 12 months ]
    To describe the clinical characteristics of patients with relapsed multiple myeloma and CrCl <50 mL/min/1.73 m2.

  3. Renal response rate assessment in clinical practice. [ Time Frame: Up to 12 months ]
    Describe response rate of renal function according to eGFR and total proteinuria

  4. Time dependent Renal response rate assessment in clinical practice. [ Time Frame: Up to 12 months ]
    Time to best renal response

  5. Type of Anti-myeloma therapeutic regimens. [ Time Frame: Up to 12 months ]
    Describe various types of anti-myeloma regimens participants will receive.

  6. Multiple Myeloma (MM) response to anti-myeloma treatment [ Time Frame: Up to 12 months ]
    MM response evaluation according to IMWG criteria

  7. MM response to Time to Progression [ Time Frame: Up to 12 months ]
    Time to progression is defined as time from baseline to the appearance of the event; considering as an event progression or death from any cause.

  8. MM response to Time to first response [ Time Frame: Up to 12 months ]
    Time to response is defined as time from the date of the first dose of study treatment to the date of the first documented hematologic improvement.

  9. MM response to Progression Free Survival [ Time Frame: Up to 12 months ]
    Progression free survival is defined as time from the date of the first dose of study treatment to the date of the first documented disease progression or relapse per IWG 2006 criteria.

  10. Adverse events (AEs) [ Time Frame: Up to 12 months ]
    Number of participants with adverse events

  11. Cost of visit to hospital/primary health care associated with anti-myeloma therapy [ Time Frame: Up to 12 months ]
    To describe the costs associated with anti-myeloma therapy in clinical practice that can be measured financially, and to explore the possible differences between the various therapeutic regimens administered. This includes, visits to hospital/primary health care center.

  12. Number of participants with relapsed kidney function [ Time Frame: Up to 36 months ]
    Concordance of the kidney function response and that of the myeloma in the clinical practice to the anti-myeloma treatment between consecutive relapses in the same patient.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  1. Patients of both genders, aged equal or more than 18 years.
  2. Patients with documented relapsed multiple myeloma according to International Myeloma Working Group ( IMWG) criteria.
  3. Patients with documented renal damage defined as creatinine clearance <50 ml / min / 1.73 m2 (CrCl <50ml / min / 1.73m2).
  4. Patients to whom the researcher decides to initiate anti-myeloma treatment for relapse with one or more agents according to clinical practice *.
  5. Patients who consent in writing after it has been clearly explained to them the nature and purpose of the study (written informed consent).
  6. 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
    • Subjects who have previously participated in the study, who meet all the inclusion criteria again and to whom none of the exclusion criteria apply, and whose current relapse is consecutive to the relapse that prompted their initial inclusion in the study.

      • 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

Exclusion Criteria:

  1. Patients who are participating in an interventional clinical trial * or who refuse to participate in the study.
  2. Patients with CrCl <50 ml / min / 1.73m2 due to a cause other than multiple myeloma properly documented at the discretion of the investigator *.

    • The inclusion of patients who are participating in another observational study is permitted.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849444


Locations
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Spain
Hospital Universitario Ciudad de Jaen
Jaen, Andalucia, Spain, 23007
Hospital Torrecárdenas
Almería, Andalucía, Spain, 04009
Hospital Universitario Puerta del Mar
Cádiz, Andalucía, Spain, 11009
Hospital Virgen de la Nieves
Granada, Andalucía, Spain, 18014
Hospital general de jeréz
Jerez de la Frontera, Andalucía, Spain, 11407
Hospital Virgen de la macarena
Sevilla, Andalucía, Spain, 41071
Hospital Miguel Servet
Zaragoza, Aragón, Spain, 50009
Hospital de Cabueñes
Gijón, Asturias, Spain, 33394
Hospital de Insular de Gran Canaria
Las Palmas de Gran Canaria, Canarias, Spain, 35010
Hospital General de Ciudad Real
Ciudad Real, Castilla La Mancha, Spain, 13005
Hospital de Basurto
Bilbao, Castilla Y León, Spain, 48013
Hospital de Burgos
Burgos, Castilla Y León, Spain, 09007
Hospital de León
León, Castilla Y León, Spain, 24001
Rio Hortega de Valladolid
Valladolid, Castilla Y León, Spain, 47003
Hospital La Ribera
Alzira, Cataluña, Spain, 46600
Hospital del Mar
Barcelona, Cataluña, Spain, 08003
Hospital Vall d´Hebron
Barcelona, Cataluña, Spain, 08035
Hospital Clinic I Provincial de Barcelona
Barcelona, Cataluña, Spain, 08208
Hospital Duran reynls
Barcelona, Cataluña, Spain, 08907
Hospital Universitario Josep Trueta de Girona
Girona, Cataluña, Spain, 17007
Hospital Arnau de Vilanova de Lleida
Lleida, Cataluña, Spain, 25198
Hospital Sant Joan de manresa
Manresa, Cataluña, Spain, 08243
Hospital de Sabadell ( Parc Taulí)
Sabadell, Cataluña, Spain, 08208
Hospital Mutua terrassa
Terrassa, Cataluña, Spain, 08221
Hospital Clínico Universitario Valencia
Valencia, Comunidad Valenciana, Spain, 46010
Hospital La fe
Valencia, Comunidad Valenciana, Spain, 46026
Complejo Hospitalario Universitario Santiago
Santiago de Compostela, Galicia, Spain, 15006
Complejo Hospitalario Universitario de Vigo
Vigo, Galicia, Spain, 36036
Hospital Son Espases
Palma de Mallorca, Islas Baleares, Spain, 07120
Hospital san pedro
Logroño, La Rioja, Spain, 26006
Hospital Fundación de Alcorcón
Alcorcón, Madrid, Spain, 28922
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Hospital Santa Lucía
Cartagena, Murcia, Spain, 30202
Hospital Virgen de Arrixaca
El Palmar, Murcia, Murcia, Spain, 30120
Hospital General de Alicante
Alicante, Valencia, Spain, 03010
Hospital Gregorio marañon
Madrid, Spain, 28007
Hospital Ramon y Cajal
Madrid, Spain, 28034
Complejo Universitario de San Carlos
Madrid, Spain, 28040
Hospital Universitario La paz
Madrid, Spain, 28046
Hospital Dr peset
Valencia, Spain, 46017
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Mireya Navarro, MD Celgene Spain

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02849444     History of Changes
Other Study ID Numbers: CEL-MIE-2012-01
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Keywords provided by Celgene:
renal function
Relapsed Multiple myeloma
anti-MM therapy
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases