First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02 (FMG-MM02)

K

Kuopio University Hospital

Status and phase

Completed
Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: Cyclophosphamide
Drug: Filgrastim

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01790737
KUH5101424
2012-001051-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 2 patient groups

A
Active Comparator group
Description:
Cyclophosphamide plus filgrastim
Treatment:
Drug: Cyclophosphamide
B
Active Comparator group
Description:
Filgrastim
Treatment:
Drug: Filgrastim

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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