Clinical trial NCT01790737: First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02
Official title: A Prospective Phase II Study to Assess Immunophenotypic Remission After 3-drug Induction Followed by Randomized Stem Cell Mobilization, Autologous Stem Cell Transplantation (ASCT) and Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: myeloma, stem cell mobilization, autologous stem cell transplantation
induction treatment, maintenance treatment
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Tampere University Hospital
name: Turku University Hospital
name: Oulu University Hospital
name: Mikkeli Central Hospital
name: Kymenlaakso Central Hospital Kotka Finland
name: Jyväskylä Central Hospital
name: Kanta-Häme Central Hospital
name: Satakunta Central Hospital
name: Kainuu Central Hospital, Kajaani
name: Celgene Corporation
First posted: 2013-02-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Immunophenotypic response
timeFrame: 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
Secondary outcomes:
measure: Progression free survival
timeFrame: 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
Other outcomes:
measure: Proportion of pts collected with >/= 3 x 10e6/kg CD34+ with </= 2 apheresis after mobilization with CY 2g/m2 + filgrastim (group A) or filgrastim alone (group B)
timeFrame: Assessed up to 2 weeks from the start of mobilization
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: North Savo
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Hämeenlinna
country: Finland
facility: Kanta-Häme Central Hospital
city: Jyväskylä
country: Finland
facility: Jyväskylä Central Finland Central Hospital
city: Kajaani
country: Finland
facility: Kainuu Kajaani Central Hospital
city: Kemi
country: Finland
facility: Länsi-Pohja Central Hospital
city: Kotka
country: Finland
facility: Kymenlaakso Central Hospital
city: Mikkeli
country: Finland
facility: Mikkeli Southern-Savo Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Pori
country: Finland
facility: Satakunta Central Hospital
city: Turku
country: Finland
facility: Turku University Central Hospital
Study officials:
affiliation: Kuopio University Hospital, Kuopio, FI
name: Raija Silvennoinen, MD
role: PRINCIPAL_INVESTIGATOR
References: