NCT01274403

Brief Summary

The aim of the study is to compare efficacy and toxicity of melphalan and prednisone versus meplhalan, prednisone and Thalidomide in elderly patients with multiple myeloma or patients with multiple myeloma but not eligible for high dose treatment with stem cells support.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P75+ for phase_2 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
Last Updated

January 11, 2011

Status Verified

December 1, 2010

First QC Date

December 28, 2010

Last Update Submit

January 10, 2011

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaElderly patients

Outcome Measures

Primary Outcomes (2)

  • To assess the efficacy

    To compare the percentage of response in term of complete response, partial response, minimal and stable disease in the 2 arms o treatment

    from 8 to 12 months

  • To assess the toxicity

    To evaluate the toxicity in the 2 arms of treatment utilized the common terminology criteria for adverse events (CTCAE) version 3.0

    From 1 to 12 months

Secondary Outcomes (2)

  • To evaluate the Overall Survival (OS) in the 2 arms of treatment

    From 1 to 60 months

  • To evaluate the Duration of Remission (DR) in the 2 arms of treatment

    From 8 to 60 months

Study Arms (2)

Melphalan, prednisone plus Thalidomide

EXPERIMENTAL
Drug: Melphalan, Prednisone and Thalidomide

Melphalan and Prednisone

ACTIVE COMPARATOR
Drug: Melphalan, Prednisone and Thalidomide

Interventions

Melphalan, Prednisone and ThalidomideDRUG
Melphalan and PrednisoneMelphalan, prednisone plus Thalidomide

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • newly diagnosed of multiple myeloma.
  • Age \> 65 years
  • ECOG \<= 3
  • Written informed consent given at the time of randomization
  • Patients with age \<= 65 but not eligible for high dose treatment with stem cells support

You may not qualify if:

  • ECOG \> 3
  • current neoplasm..
  • contraindications to use thalidomide
  • peripheral neurophaty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gruppo Italiano Studio Linfoma

Modena, Modena, 41120, Italy

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

MelphalanPrednisoneThalidomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 28, 2010

First Posted

January 11, 2011

Last Updated

January 11, 2011

Record last verified: 2010-12

Locations

IT(1)