First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02
NCT ID: NCT01790737
Last Updated: 2019-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2013-01-31
2019-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
Cyclophosphamide plus filgrastim
Cyclophosphamide
B
Filgrastim
Filgrastim
Interventions
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Cyclophosphamide
Filgrastim
Eligibility Criteria
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Inclusion Criteria
* symptomatic, previously untreated International Stating System (ISS) 1-3 myeloma
* measurable disease
* WHO perf status 0-3
* eligible for ASCT
Exclusion Criteria
* peripheral neuropathy gr \>/= 2
* significant hepatic dysfunction
* severe cardiac dysfunction
* severe renal failure if not in dialysis
18 Years
70 Years
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
Tampere University Hospital
OTHER
Turku University Hospital
OTHER_GOV
Oulu University Hospital
OTHER
Mikkeli Central Hospital
OTHER
Kymenlaakso Central Hospital Kotka Finland
OTHER
Jyväskylä Central Hospital
OTHER
Kanta-Häme Central Hospital
OTHER_GOV
Satakunta Central Hospital
OTHER
Kainuu Central Hospital, Kajaani
OTHER
Celgene Corporation
INDUSTRY
Kuopio University Hospital
OTHER
Responsible Party
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Principal Investigators
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Raija Silvennoinen, MD
Role: PRINCIPAL_INVESTIGATOR
Kuopio University Hospital, Kuopio, FI
Locations
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Kuopio University Hospital
Kuopio, Northern Savonia, Finland
Tampere University Hospital
Tampere, Pirkanmaa, Finland
Kanta-Häme Central Hospital
Hämeenlinna, , Finland
Helsinki University Hospital
Helsinki, , Finland
Jyväskylä Central Finland Central Hospital
Jyväskylä, , Finland
Kainuu Kajaani Central Hospital
Kajaani, , Finland
Länsi-Pohja Central Hospital
Kemi, , Finland
Kymenlaakso Central Hospital
Kotka, , Finland
Mikkeli Southern-Savo Central Hospital
Mikkeli, , Finland
Oulu University Hospital
Oulu, , Finland
Satakunta Central Hospital
Pori, , Finland
Turku University Central Hospital
Turku, , Finland
Countries
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Other Identifiers
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2012-001051-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KUH5101424
Identifier Type: -
Identifier Source: org_study_id
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