NCT00367185

Brief Summary

In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used since the 1960s and is regarded as the standard of care in elderly patients. We assess whether the addition of thalidomide to this combination or adapted high-dose chemotherapy, using a melphalan 100 mg/m2 -based regimen, would improve survival.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P50-P75 for phase_3 multiple-myeloma

Timeline
Completed

Started May 2000

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

May 1, 2000

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2006

Completed
Last Updated

August 22, 2006

Status Verified

April 1, 2006

First QC Date

August 21, 2006

Last Update Submit

August 21, 2006

Conditions

Multiple Myeloma

Keywords

Multiple myelomaElderly patientsThalidomideAutologous transplantation

Outcome Measures

Primary Outcomes (1)

  • Overall survival

Secondary Outcomes (4)

  • Best response rate

  • Progression-free survival

  • Survival after progression

  • Toxicity

Interventions

ThalidomideDRUG

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Stage II or III multiple myeloma according to Durie and Salmon criteria.
  • Patients between 65 and 75 years of age
  • Previously untreated patients

You may not qualify if:

  • Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma)
  • Primary or associated amyloidosis
  • World Health organisation performance index of at least 3
  • Significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more
  • Cardiac or hepatic dysfunction
  • Cerebral circulatory insufficiency
  • Absolute contraindication to corticosteroids
  • Peripheral neuropathy
  • HIV or hepatitis B or C positivity
  • Patients who had geographic, social or psychological conditions which might prevent adequate follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lille University Hospital

Lille, 59037, France

Location

Related Publications (1)

  • Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, Renaud M, Harousseau JL, Guillerm G, Chaleteix C, Dib M, Voillat L, Maisonneuve H, Troncy J, Dorvaux V, Monconduit M, Martin C, Casassus P, Jaubert J, Jardel H, Doyen C, Kolb B, Anglaret B, Grosbois B, Yakoub-Agha I, Mathiot C, Avet-Loiseau H; Intergroupe Francophone du Myelome. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet. 2007 Oct 6;370(9594):1209-18. doi: 10.1016/S0140-6736(07)61537-2.

    PMID: 17920916DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Thalidomide

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-Ring

Study Officials

  • Jean-Yves MARY

    U717 INSERM universite Paris7, Hopital Saint-Louis, Paris, France

    STUDY DIRECTOR

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

August 21, 2006

First Posted

August 22, 2006

Study Start

May 1, 2000

Study Completion

October 1, 2005

Last Updated

August 22, 2006

Record last verified: 2006-04

Locations

FR(1)