NCT01296503

Brief Summary

This multicenter, prospective, randomized trial was designed to evaluate the role of thalidomide with or without dexamethasone as a maintenance therapy for multiple myeloma patients after a single autologous stem cell transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
213

participants targeted

Target at P25-P50 for phase_3 multiple-myeloma

Timeline
Completed

Started Oct 2003

Typical duration for phase_3 multiple-myeloma

Geographic Reach
1 country

4 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

October 1, 2003

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 15, 2011

Completed
Last Updated

February 15, 2011

Status Verified

February 1, 2011

Enrollment Period

4.8 years

First QC Date

January 27, 2011

Last Update Submit

February 14, 2011

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaTreatmentMaintenanceThalidomide

Outcome Measures

Primary Outcomes (1)

  • Progression Free survival

    Primary endpoint: progression free survival (PFS) PFS was defined as the time between randomization and any documentation of relapse, progression, or death by any cause.

    36 months

Secondary Outcomes (2)

  • Overall survival

    36 months

  • safety of thalidomide

    36 months

Study Arms (2)

Dexamethasone (Arm A)

ACTIVE COMPARATOR

Sixty days (D+60) after ASCT: randomization in two arms of maintenance: Arm A (dexamethasone alone 40 mg/day for 4 days every 28 days)

Drug: Dexamethasone

Thalidomide and Dexamethasone (Arm B)

EXPERIMENTAL

D+60 after ASCT: dexamethasone plus thalidomide 200 mg by mouth daily for 12 months or until disease progression. The dose of thalidomide could be reduced if the patient experienced grade 2 or higher adverse events. In this case, thalidomide was discontinued and re-challenged at a lower dose after resolution of the adverse event.

Drug: Thalidomide plus dexamethasone

Interventions

Thalidomide plus dexamethasoneDRUG

D+60 after ASCT: randomization in two arms of maintenance: Arm A (dexamethasone alone 40 mg/day for 4 days every 28 days) and Arm B (dexamethasone plus thalidomide 200 mg by mouth daily) for 12 months or until disease progression. The dose of thalidomide could be reduced if the patient experienced grade 2 or higher adverse events. In this case, thalidomide was discontinued and re-challenged at a lower dose after resolution of the adverse event.

Also known as: Thalomid, Baycadron, DexPak, Decadron
Thalidomide and Dexamethasone (Arm B)
DexamethasoneDRUG

dexamethasone alone 40 mg/day for 4 days every 28 days

Also known as: Baycadron, DexPak, Decadron
Dexamethasone (Arm A)

Eligibility Criteria

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

You may qualify if:

  • symptomatic multiple myeloma in accordance with the International Myeloma Working Group criteria;
  • age 18-70 years;
  • Performance status 0-2 by the Eastern Cooperative Oncology Group (ECOG) criteria;
  • normal hepatic function, defined as serum bilirubin \<3 mg/dl and alanine aminotransferase(ALT) and asparagin aminotransferase (AST) \<4x normal.

You may not qualify if:

  • evidence of disease progression after ASCT;
  • cardiac dysfunction (systolic ejection fraction \<50%);
  • chronic respiratory disease (carbon monoxide diffusion \<50% of normal).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Universitário Clementino Fraga Filho

Rio de Janeiro, Rio de Janeiro, 21941913, Brazil

Location

Universidade Estadual de Campinas

Campinas, São Paulo, Brazil

Location

Universidade de São Paulo- Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Location

Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

ThalidomideDexamethasoneCalcium Dobesilate

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-RingPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Angelo Maiolino, MD, PhD

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 27, 2011

First Posted

February 15, 2011

Study Start

October 1, 2003

Primary Completion

July 1, 2008

Study Completion

December 1, 2010

Last Updated

February 15, 2011

Record last verified: 2011-02

Locations

BR(4)