First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02

NCT ID: NCT01790737

Last Updated: 2019-03-01

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2019-02-26

Brief Summary

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The purpose of this study is to determinate the efficacy and safety of the 3-drug induction treatment (RVD; lenalidomide plus bortezomib plus dexamethasone)followed by randomized autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance. Primary endpoint is the immunophenotypic remission rate.During the randomized mobilization phase two active comparator arms Cyclophosphamide (CY)2g/m2 + Granulocyte-colony stimulating factor(G-CSF) vrs G-CSF will be compared regarding efficacy, costs and safety.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Cyclophosphamide plus filgrastim

Group Type ACTIVE_COMPARATOR

Cyclophosphamide

Intervention Type DRUG

B

Filgrastim

Group Type ACTIVE_COMPARATOR

Filgrastim

Intervention Type DRUG

Interventions

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Cyclophosphamide

Intervention Type DRUG

Filgrastim

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* written informed consent
* symptomatic, previously untreated International Stating System (ISS) 1-3 myeloma
* measurable disease
* WHO perf status 0-3
* eligible for ASCT

Exclusion Criteria

* previously treated
* peripheral neuropathy gr \>/= 2
* significant hepatic dysfunction
* severe cardiac dysfunction
* severe renal failure if not in dialysis
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role collaborator

Oulu University Hospital

OTHER

Sponsor Role collaborator

Mikkeli Central Hospital

OTHER

Sponsor Role collaborator

Kymenlaakso Central Hospital Kotka Finland

OTHER

Sponsor Role collaborator

Jyväskylä Central Hospital

OTHER

Sponsor Role collaborator

Kanta-Häme Central Hospital

OTHER_GOV

Sponsor Role collaborator

Satakunta Central Hospital

OTHER

Sponsor Role collaborator

Kainuu Central Hospital, Kajaani

OTHER

Sponsor Role collaborator

Celgene Corporation

INDUSTRY

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Tampere University Hospital

Tampere, Pirkanmaa, Finland

Site Status

Kanta-Häme Central Hospital

Hämeenlinna, , Finland

Site Status

Helsinki University Hospital

Helsinki, , Finland

Site Status

Jyväskylä Central Finland Central Hospital

Jyväskylä, , Finland

Site Status

Kainuu Kajaani Central Hospital

Kajaani, , Finland

Site Status

Länsi-Pohja Central Hospital

Kemi, , Finland

Site Status

Kymenlaakso Central Hospital

Kotka, , Finland

Site Status

Mikkeli Southern-Savo Central Hospital

Mikkeli, , Finland

Site Status

Oulu University Hospital

Oulu, , Finland

Site Status

Satakunta Central Hospital

Pori, , Finland

Site Status

Turku University Central Hospital

Turku, , Finland

Site Status

Countries

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Finland

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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