Trial Outcomes & Findings for Study of Induction Therapy With Mitoxantrone and Plasmapheresis to Treat Aggressive Multiple Sclerosis (NCT NCT01214317)

NCT ID: NCT01214317

Last Updated: 2020-09-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: At the end of month 8 after treatment initiation
• Results posted on: 2020-09-16

Participant Flow

Participant milestones

Measure	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 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.	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.
Overall Study STARTED	18	22
Overall Study COMPLETED	18	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Mitoxantrone and Plasmapheresis n=18 Participants 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	Mitoxantrone n=22 Participants	Total n=40 Participants Total of all reporting groups
Age, Continuous	30.4 years STANDARD_DEVIATION 11.3 • n=5 Participants	29.1 years STANDARD_DEVIATION 6.7 • n=7 Participants	29.68 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Iran	18 participants n=5 Participants	22 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Mitoxantrone and Plasmapheresis n=18 Participants 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.	Mitoxantrone n=22 Participants 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.
Expanded Disability Status Score	2.9 score on a scale Standard Deviation 1.3	2.6 score on a scale Standard Deviation 0.9

PRIMARY outcome

Timeframe: Month 8 after treatment initiation

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

Outcome measures

Measure	Mitoxantrone and Plasmapheresis n=18 Participants 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.	Mitoxantrone n=22 Participants 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.
Change From Baseline in Mean Number of MS Plaques Found on Brain MRI	3.5 Plaques Standard Deviation 0.9	7.3 Plaques Standard Deviation 1.6

Adverse Events

Mitoxantrone and Plasmapheresis

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Mitoxantrone

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mitoxantrone and Plasmapheresis n=18 participants at risk 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	Mitoxantrone n=22 participants at risk
Blood and lymphatic system disorders Anemia	5.6% 1/18 • 8 months	4.5% 1/22 • 8 months
Reproductive system and breast disorders Transient amenorrhea	22.2% 4/18 • 8 months	22.7% 5/22 • 8 months
Gastrointestinal disorders Nausea	0.00% 0/18 • 8 months	4.5% 1/22 • 8 months
Gastrointestinal disorders Transient rise in liver enzymes	5.6% 1/18 • 8 months	0.00% 0/22 • 8 months

Additional Information

Director of clinical trial

Isfahan University of medical sciences

Phone: +983136202020

Email: etemadifar.m@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place