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

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Cyclophosphamide; Drug: Filgrastim

• Registration Number: NCT01790737
• Lead Sponsor: Kuopio University Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-04
• Study First Submitted QC: 2013-02-11
• Study First Posted: 2013-02-13
• Primary Completion: 2018-10-10
• Status Verified: 2019-02
• Study Completion: 2019-02-26
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Cyclophosphamide	Cyclophosphamide plus filgrastim
B	Filgrastim	Filgrastim

Primary Outcome Measures

Name	Time	Method
Immunophenotypic response	Change from the start of induction treatment at 3 months, change from the start of induction at 6 months, at 9 months, at 12 months, at 16 months, at 20 months, at 24 moths	Response will be measured by International Myeloma Working Group (IMWG) guidelines, and if the response is stringent CR and immunophenotypic remission, those patients will be followed also by allele-spesific oligonucleotide-polymerase chain reaction assay (ASO-PCR) to find out molecular remission rate.

Secondary Outcome Measures

Name	Time	Method
Progression free survival	From date of inclusion until the date of first documented progression or date of death from any cause whatever come first assessed up to last patient 2 years on maintenance

Trial Locations

Locations (12)

Kuopio University Hospital; 🇫🇮 Kuopio, North Savo, Finland

Tampere University Hospital; 🇫🇮 Tampere, Pirkanmaa, Finland

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Kanta-Häme Central Hospital; 🇫🇮 Hämeenlinna, 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

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