NCT01790737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2 multiple-myeloma

Timeline
Completed

Started Jan 2013

Typical duration for phase_2 multiple-myeloma

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2019

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

5.8 years

First QC Date

February 4, 2013

Last Update Submit

February 27, 2019

Conditions

Multiple Myeloma

Keywords

myeloma, stem cell mobilization, autologous stem cell transplantationinduction treatment, maintenance treatment

Outcome Measures

Primary Outcomes (1)

  • Immunophenotypic response

    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.

    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 (1)

  • 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

Other Outcomes (1)

  • 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)

    Assessed up to 2 weeks from the start of mobilization

Study Arms (2)

A

ACTIVE COMPARATOR

Cyclophosphamide plus filgrastim

Drug: Cyclophosphamide

B

ACTIVE COMPARATOR

Filgrastim

Drug: Filgrastim

Interventions

CyclophosphamideDRUG
A
FilgrastimDRUG
B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Kuopio University Hospital

Kuopio, Northern Savonia, 70200, Finland

Location

Tampere University Hospital

Tampere, Pirkanmaa, 33100, Finland

Location

Kanta-Häme Central Hospital

Hämeenlinna, Finland

Location

Helsinki University Hospital

Helsinki, Finland

Location

Jyväskylä Central Finland Central Hospital

Jyväskylä, Finland

Location

Kainuu Kajaani Central Hospital

Kajaani, Finland

Location

Länsi-Pohja Central Hospital

Kemi, Finland

Location

Kymenlaakso Central Hospital

Kotka, Finland

Location

Mikkeli Southern-Savo Central Hospital

Mikkeli, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Satakunta Central Hospital

Pori, Finland

Location

Turku University Central Hospital

Turku, Finland

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

CyclophosphamideFilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsGranulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Raija Silvennoinen, MD

    Kuopio University Hospital, Kuopio, FI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2013

First Posted

February 13, 2013

Study Start

January 1, 2013

Primary Completion

October 10, 2018

Study Completion

February 26, 2019

Last Updated

March 1, 2019

Record last verified: 2019-02

Locations

FI(12)