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Studies in Patients With Multiple Myeloma and Renal Failure Due to Myeloma Cast Nephropathy (MYRE)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01208818
First Posted: September 24, 2010
Last Update Posted: June 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
MYRE is a phase III multicentric controlled national clinical trial conducted in patients with multiple myeloma and renal failure related to myeloma cast nephropathy (MCN). Its aims are to assess (1) the efficacy of bortezomib plus dexamethasone (BD), compared with cyclophosphamide, plus bortezomib and dexamethasone (C-BD) in patients with inaugural MCN not requiring hemodialysis; and (2) in patients with inaugural severe renal failure secondary to biopsy-proven MCN and requiring hemodialysis that of an intensive hemodialysis regimen using either a dialyser with very high permeability to proteins (TheraliteTM) or a conventional high-flux dialyser, while receiving chemotherapy with BD.

Condition Intervention Phase
Chronic Renal Failure With Uremic Nephropathy Drug: Cyclophosphamide + Bortezomib + Dexamethasone regimen Drug: Bortezomib +Dexamethasone regimen Device: HCO group Device: conventional high-flux dialyzer Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Renal Failure Due to Myeloma Cast Nephropathy: Comparison of Two Different Chemotherapy Regimens and Evaluation of Optimized Removal of Monoclonal Immunoglobulin Light Chains Using a High Permeability Hemodialysis Membrane.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Prevalence of renal response (if dialysis not mandatory at baseline: strata 1); Prevalence of patients free of dialysis (if dialysis required at baseline; strata 2) [ Time Frame: 3 months after randomization ]
    • renal response is defined by creatinine≤ 170 µmol/l and/or DFG (modified MDRD) ≥ 40 ml/min/1.73m2
    • the absence of any dialysis requirement will be defined by an eDFG > 15 ml/min/1.73 m2, 15 days after the last hemodialysis session


Secondary Outcome Measures:
  • Improvement in renal function [ Time Frame: after 1 cycle of chemotherapy, at the end of chemotherapy, at 6 months and 1 year ]
    • DFG (modified MDRD)
    • hemodialysis requirement

  • Hematological response [ Time Frame: after 1 and 3 courses, at the end of chemotherapy and at 1 year ]
    Partial Response (PR) Very Good Partial Response (VGPR) Complete Response (CR)

  • Progression free survival (PFS) [ Time Frame: 4 years ]
    Time to progression, relapse or death from randomization

  • Time to treatment Failure (TTF) [ Time Frame: 4 years ]
    Time from randomization to progression, relapse, non scheduled hematological treatment or death

  • Overall survival (OS) [ Time Frame: 4 years ]
    Time to death from randomization


Estimated Enrollment: 284
Study Start Date: June 2011
Estimated Study Completion Date: September 2017
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BD Drug: Bortezomib +Dexamethasone regimen

Dosing regimen (21 day-cycle):

  • Bortezomib 1.3 mg/m2 I.V. on days 1, 4, 8, and 11. An interval of at least 72 hours between each administration of bortezomib is required.
  • Dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12. The regimen is given for 3 cycles in the absence of serious side-effect.
Experimental: C-BD Drug: Cyclophosphamide + Bortezomib + Dexamethasone regimen

Dosing regimen (21 day-cycle):

  • Bortezomib 1.3 mg/m2 I.V. on days 1, 4, 8, and 11. An interval of at least 72 hours between each administration of bortezomib is required.
  • Dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12.
  • Cyclophosphamide 900 mg/m2 on day 1, through a short I.V. infusion The regimen is given for 3 cycles in the absence of serious side-effect.
Experimental: HCO Drug: Bortezomib +Dexamethasone regimen

Dosing regimen (21 day-cycle):

  • Bortezomib 1.3 mg/m2 I.V. on days 1, 4, 8, and 11. An interval of at least 72 hours between each administration of bortezomib is required.
  • Dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12. The regimen is given for 3 cycles in the absence of serious side-effect.
Device: HCO group
TheraliteTM dialyzer of 2.1 m2 in surface
Active Comparator: Control HD Drug: Bortezomib +Dexamethasone regimen

Dosing regimen (21 day-cycle):

  • Bortezomib 1.3 mg/m2 I.V. on days 1, 4, 8, and 11. An interval of at least 72 hours between each administration of bortezomib is required.
  • Dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12. The regimen is given for 3 cycles in the absence of serious side-effect.
Device: conventional high-flux dialyzer
conventional high-flux dialyzer; polyacrylonitrile, polysulfone, or PMMA dialysers, with an ultrafiltration coefficient > 14 ml/min and ≥ 1.8 m2 in surface, are recommended.

Detailed Description:

MYRE is a phase III multicentric controlled national clinical trial conducted in patients with multiple myeloma and renal failure related to myeloma cast nephropathy (MCN). Its aims are to assess (1) the efficacy of bortezomib plus dexamethasone (BD), compared with cyclophosphamide, plus bortezomib and dexamethasone (C-BD) in patients with inaugural MCN not requiring hemodialysis; and (2) in patients with inaugural severe renal failure secondary to biopsy-proven MCN and requiring hemodialysis that of an intensive hemodialysis regimen using either a dialyser with very high permeability to proteins (TheraliteTM) or a conventional high-flux dialyser, while receiving chemotherapy with BD.

Study hypotheses are: (1) in patients not requiring dialysis, based on renal response after 3 cycles as the main endpoint, to show a benefit of 30% in absolute rate from an expected 30% response rate in the control arm; and (2) in patients requiring hemodialysis, using the prevalence of patients free of dialysis after 3 cycles as the main endpoint, to show a benefit of at least 20% from an assumed rate of 50% in the control arm. A total sample size of 284 patients was computed to be enrolled (type I and II error rates at 5 and 20%, respectively).

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age >=18 years old
  • Serum creatinine > 170µmol/l and/or DFG < 40 ml/min/1.73 m2
  • Myeloma cast nephropathy (MCN)
  • Multiple myeloma
  • Informed consent
  • neutrophils >= 1 Giga/L and platelets >= 70 Giga/L

Exclusion Criteria:

  • Amylosis
  • Chronic renal Failure with eDFG < 30 ml/min/1.73 m2, unrelated to myeloma
  • Peripheral neuropathy
  • Contraindications to either corticosteroids or Bortezomib
  • Patient refusal
  • Known HIV infection
  • Concomitant severe disease including neoplasias (except basocellular carcinoma)
  • Liver failure, cytolysis, and/or cholestasis
  • Fertile women who refuse or cannot use effective contraception; Women pregnant or nursing; Women with positive test pregnancy (test before treatment initiation)
  Contacts and Locations
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): NCT01208818


Locations
France
Hôpital Saint Louis
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean-Paul Fermand, MD Hôpital saint Louis, Paris, France
Study Director: Franck Bridoux, MD, PhD CHU Poitiers
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01208818     History of Changes
Other Study ID Numbers: P081226
First Submitted: September 23, 2010
First Posted: September 24, 2010
Last Update Posted: June 15, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Dexamethasone acetate
Dexamethasone
Cyclophosphamide
Bortezomib
BB 1101
Immunoglobulin Light Chains
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents