IMPAMS: Study of Induction Therapy With Mitoxantrone and Plasmapheresis to Treat Aggressive Multiple Sclerosis

Sponsor
Isfahan University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01214317
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
25
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the effect of combinative induction therapy with mitoxantrone and plasmapheresis versus induction therapy with mitoxantrone alone in cases of aggressive multiple sclerosis

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: plasmapheresis
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Study of Combinative Effect of Induction Therapy With Mitoxantrone and Plasmapheresis to Treat Patients With Aggressive Multiple Sclerosis
Actual Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: mitoxantrone and plasmapheresis

Monthly Plasmapheresis (plasma exchange machine: Haemonetics, model TCS2, USA) 25 ml/kg for 5 cycles, with replacement of 0.9% saline and 5% human serum albumin followed by monthly IV infusion of 12 mg/m2 mitoxantrone (EBEWE Pharma, Amsterdam, The Netherlands) at the end of each Plasmapheresis course for three successive months. Then, treatment is continued by adding two more 6 mg/m2 doses of mitoxantrone in 3-month intervals.

Procedure: plasmapheresis
3 courses of plasmapheresis are performed before mitoxantrone injection in first 3 months to investigate the efficacy of plasmapheresis in comparison with the other arm that are only treated with mitoxantrone
Other Names:
  • novantrone
  • plasma exchange
  • No Intervention: mitoxantrone

    Monthly IV infusion of 12 mg/m2 mitoxantrone (EBEWE Pharma, Amsterdam, The Netherlands) for three successive months. Then, treatment is continued by adding two more 6 mg/m2 doses of mitoxantrone in 3-month intervals.

    Outcome Measures

    Primary Outcome Measures

    1. Expanded Disability Status Score [At the end of month 8 after treatment initiation]

      The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and defines functional systems as pyramidalm, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral and others. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.

    2. Change From Baseline in Mean Number of MS Plaques Found on Brain MRI [Month 8 after treatment initiation]

      Change From Baseline in Mean Number of MS plaques found on Brain MRI 8 months after treatment initiation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Aggressive multiple sclerosis in attack phase

    • EDSS: 1-5

    • No contraindication for mitoxantrone prescription

    • No past history of mitoxantrone injection

    • No history of corticosteroid and immunosuppressive therapy in last 3 months

    Exclusion Criteria:
    • Patient's incompliance

    • Severe drug induced side effects

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Alahra hospitalIsfahanIran, Islamic Republic of

    Sponsors and Collaborators

    • Isfahan University of Medical Sciences

    Investigators

    • Principal Investigator: Masoud Etemadifar, Alzahra Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Masoud Etemadifar, Professor of neurology, Isfahan University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT01214317
    Other Study ID Numbers:
    • 389050
    First Posted:
    Oct 5, 2010
    Last Update Posted:
    Sep 16, 2020
    Last Verified:
    Aug 1, 2020
    Keywords provided by Masoud Etemadifar, Professor of neurology, Isfahan University of Medical Sciences
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleMitoxantrone and PlasmapheresisMitoxantrone
    Arm/Group DescriptionMonthly plasmapheresis (plasma exchange machine: Haemonetics, model TCS2, USA) 25 ml/kg for 5 cycles, with replacement of 0.9% saline and 5% human serum albumin followed by monthly IV infusion of 12 mg/m2 mitoxantrone (EBEWE Pharma, Amsterdam, The Netherlands) at the end of each plasmapheresis course for three successive months to investigate the efficacy of plasmapheresis in comparison with the other arm that are only treated with mitoxantrone. Then, treatment is continued by adding two more 6 mg/m2 doses of mitoxantrone in 3-month intervals.Monthly IV infusion of 12 mg/m2 mitoxantrone (EBEWE Pharma, Amsterdam, The Netherlands) for three successive months. Then, treatment is continued by adding two more 6 mg/m2 doses of mitoxantrone in 3-month intervals.
    Period Title: Overall Study
    STARTED1822
    COMPLETED1822
    NOT COMPLETED00

    Baseline Characteristics

    Arm/Group TitleMitoxantrone and PlasmapheresisMitoxantroneTotal
    Arm/Group Descriptionplasmapheresis: 3 courses of plasmapheresis are performed before mitoxantrone injection in first 3 months to investigate the efficacy of plasmapheresis in comparison with the other arm that are only treated with mitoxantroneTotal of all reporting groups
    Overall Participants182240
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    30.4
    (11.3)
    29.1
    (6.7)
    29.68
    (8.8)
    Sex: Female, Male (Count of Participants)
    Female
    14
    77.8%
    17
    77.3%
    31
    77.5%
    Male
    4
    22.2%
    5
    22.7%
    9
    22.5%
    Region of Enrollment (participants) [Number]
    Iran
    18
    100%
    22
    100%
    40
    100%

    Outcome Measures

    1. Primary Outcome
    TitleExpanded Disability Status Score
    DescriptionThe Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and defines functional systems as pyramidalm, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral and others. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
    Time FrameAt the end of month 8 after treatment initiation

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMitoxantrone and PlasmapheresisMitoxantrone
    Arm/Group DescriptionMonthly Plasmapheresis (plasma exchange machine: Haemonetics, model TCS2, USA) 25 ml/kg for 5 cycles, with replacement of 0.9% saline and 5% human serum albumin followed by monthly IV infusion of 12 mg/m2 mitoxantrone (EBEWE Pharma, Amsterdam, The Netherlands) at the end of each Plasmapheresis course for three successive months. Then, treatment is continued by adding two more 6 mg/m2 doses of mitoxantrone in 3-month intervals.Monthly IV infusion of 12 mg/m2 mitoxantrone (EBEWE Pharma, Amsterdam, The Netherlands) for three successive months. Then, treatment is continued by adding two more 6 mg/m2 doses of mitoxantrone in 3-month intervals.
    Measure Participants1822
    Mean (Standard Deviation) [score on a scale]
    2.9
    (1.3)
    2.6
    (0.9)
    2. Primary Outcome
    TitleChange From Baseline in Mean Number of MS Plaques Found on Brain MRI
    DescriptionChange From Baseline in Mean Number of MS plaques found on Brain MRI 8 months after treatment initiation
    Time FrameMonth 8 after treatment initiation

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMitoxantrone and PlasmapheresisMitoxantrone
    Arm/Group Descriptionplasmapheresis: 3 courses of plasmapheresis are performed before mitoxantrone injection in first 3 months to investigate the efficacy of plasmapheresis in comparison with the other arm that are only treated with mitoxantrone
    Measure Participants1822
    Mean (Standard Deviation) [Plaques]
    3.5
    (0.9)
    7.3
    (1.6)

    Adverse Events

    Time Frame8 months
    Adverse Event Reporting Description
    Arm/Group TitleMitoxantrone and PlasmapheresisMitoxantrone
    Arm/Group Descriptionplasmapheresis: 3 courses of plasmapheresis are performed before mitoxantrone injection in first 3 months to investigate the efficacy of plasmapheresis in comparison with the other arm that are only treated with mitoxantrone
    All Cause Mortality
    Mitoxantrone and PlasmapheresisMitoxantrone
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/18 (0%) 0/22 (0%)
    Serious Adverse Events
    Mitoxantrone and PlasmapheresisMitoxantrone
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/18 (0%) 0/22 (0%)
    Other (Not Including Serious) Adverse Events
    Mitoxantrone and PlasmapheresisMitoxantrone
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total6/18 (33.3%) 7/22 (31.8%)
    Blood and lymphatic system disorders
    Anemia1/18 (5.6%) 1/22 (4.5%)
    Gastrointestinal disorders
    Nausea0/18 (0%) 1/22 (4.5%)
    Transient rise in liver enzymes1/18 (5.6%) 0/22 (0%)
    Reproductive system and breast disorders
    Transient amenorrhea4/18 (22.2%) 5/22 (22.7%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleDirector of clinical trial
    OrganizationIsfahan University of medical sciences
    Phone+983136202020
    Emailetemadifar.m@gmail.com
    Responsible Party:
    Masoud Etemadifar, Professor of neurology, Isfahan University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT01214317
    Other Study ID Numbers:
    • 389050
    First Posted:
    Oct 5, 2010
    Last Update Posted:
    Sep 16, 2020
    Last Verified:
    Aug 1, 2020