NCT00633542

Brief Summary

This is randomized, multicentre study aimed to compare a standard maintenance therapy with Interferon-Dexamethasone with an experimental therapy based on Thalidomide-Dexamethasone in patients with multiple myeloma who responded to ThaDD induction therapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at below P25 for phase_3 multiple-myeloma

Timeline
Completed

Started Jun 2003

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
Last Updated

March 12, 2008

Status Verified

March 1, 2008

Enrollment Period

4.3 years

First QC Date

January 2, 2008

Last Update Submit

March 4, 2008

Conditions

Multiple Myeloma

Keywords

thalidomidemaintenanceinterferondexamethasonenewly diagnosed multiple myelomarelapsed refractory multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    3 years

Secondary Outcomes (1)

  • overall survival safety

    3 years

Study Arms (2)

TD

EXPERIMENTAL

thalidomide-dexamethasone

Drug: thalidomide

ID

ACTIVE COMPARATOR

Interferon-dexamethasone

Drug: interferon alpha

Interventions

thalidomideDRUG

100 mg/day orally until progression or severe toxicity

TD
interferon alphaDRUG

3 MU 3 times a week until progression or severe toxicity

ID

Eligibility Criteria

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

You may qualify if:

  • patients with newly diagnosed or advanced multiple myeloma achieving at least a minimal response after induction with ThaDD regimen
  • Written consent

You may not qualify if:

  • peripheral neuropathy \>= grade 2
  • neutropenia \< 1000/mcl or thrombocytopenia \< 50000/mcl
  • severe depression
  • organ disfunction \> grade 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica di ematologia ospedali riuniti ancona università politecnica delle marche

Ancona, 60020, Italy

Location

Related Publications (1)

  • Offidani M, Corvatta L, Piersantelli MN, Visani G, Alesiani F, Brunori M, Galieni P, Catarini M, Burattini M, Centurioni R, Ferranti M, Rupoli S, Scortechini AR, Giuliodori L, Candela M, Capelli D, Montanari M, Olivieri A, Poloni A, Polloni C, Marconi M, Leoni P. Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma. Blood. 2006 Oct 1;108(7):2159-64. doi: 10.1182/blood-2006-03-013086. Epub 2006 Jun 8.

    PMID: 16763209BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Interventions

ThalidomideInterferon-alpha

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)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Offidani Massimo, MD

    clinica di ematologia ospedali riuniti ancona università politecnica delle marche

    PRINCIPAL INVESTIGATOR

  • Pietro Leoni, MD, PhD

    clinica di ematologia università politecnica delle marche

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 2, 2008

First Posted

March 12, 2008

Study Start

June 1, 2003

Primary Completion

September 1, 2007

Study Completion

October 1, 2007

Last Updated

March 12, 2008

Record last verified: 2008-03

Locations

IT(1)