NCT00232934

Brief Summary

The purpose of this study is to determine whether the association of Thalidomide to Melphalan and Prednisone is effective in the treatment of newly diagnosed elderly multiple myeloma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P50-P75 for phase_3 multiple-myeloma

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_3 multiple-myeloma

Geographic Reach
1 country

13 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

January 1, 2002

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed
9.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

August 2, 2018

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

October 4, 2005

Last Update Submit

August 1, 2018

Conditions

Multiple Myeloma

Keywords

MyelomaThalidomideDiagnosisElderly patients

Outcome Measures

Primary Outcomes (3)

  • Response Rate

  • Progression Free Survival

  • Event Free Survival

Secondary Outcomes (2)

  • Safety

  • Overall Survival

Interventions

ThalidomideDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • untreated myeloma patients
  • age \>65 years of age or younger but excluded from transplant procedure
  • Durie \& Salmon stage II or III myeloma and measurable disease.
  • Patients agreed to use contraception

You may not qualify if:

  • other cancer
  • psychiatric disease and any grade 2 peripheral neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Divisionedi Ematologia - Ospedali Riuniti

Bergamo, 24127, Italy

Location

Istituto di Ematologia e Oncologia Medica "Seragnoli"- Università di Bologna

Bologna, 40138, Italy

Location

Divisione di Ematologia - Az. Osp. S.Croce Carle

Cuneo, 26100, Italy

Location

U.O. di Ematologia e Trapianto di Cellule Staminali, IRCCS Casa Sollievo della Sofferenza

Foggia, 71013, Italy

Location

Ematologia - H.S. Gerardo

Monza, 20052, Italy

Location

Cattedra e Divisione di Ematologia Università Federico II

Napoli, 80131, Italy

Location

Divisione di Ematologia e Trapianto di Midollo Osseo- Ospedale Cervello

Palermo, 90146, Italy

Location

Clinica Medica I, Policlinico Monteluce

Perugia, 06123, Italy

Location

Divisione di Ematologia Ospedali Riuniti

Reggio Calabria, 89100, Italy

Location

Cattedra e Divisione di Ematologia Università TOR Vergata Ospedale S.Eugenio

Roma, 00100, Italy

Location

Dipartimento di Biotecnologie ed Ematologia - Università La Sapienza

Roma, 00161, Italy

Location

Istituto di Ematologia - Università Cattolica

Roma, 00168, Italy

Location

Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista

Torino, 10126, Italy

Location

Related Publications (6)

  • San Miguel JF, Blade Creixenti J, Garcia-Sanz R. Treatment of multiple myeloma. Haematologica. 1999 Jan;84(1):36-58.

    PMID: 10091392BACKGROUND

  • Singhal S, Mehta J, Desikan R, Ayers D, Roberson P, Eddlemon P, Munshi N, Anaissie E, Wilson C, Dhodapkar M, Zeddis J, Barlogie B. Antitumor activity of thalidomide in refractory multiple myeloma. N Engl J Med. 1999 Nov 18;341(21):1565-71. doi: 10.1056/NEJM199911183412102.

    PMID: 10564685BACKGROUND

  • Hideshima T, Chauhan D, Shima Y, Raje N, Davies FE, Tai YT, Treon SP, Lin B, Schlossman RL, Richardson P, Muller G, Stirling DI, Anderson KC. Thalidomide and its analogs overcome drug resistance of human multiple myeloma cells to conventional therapy. Blood. 2000 Nov 1;96(9):2943-50.

    PMID: 11049970BACKGROUND

  • Gay F, Larocca A, Wijermans P, Cavallo F, Rossi D, Schaafsma R, Genuardi M, Romano A, Liberati AM, Siniscalchi A, Petrucci MT, Nozzoli C, Patriarca F, Offidani M, Ria R, Omede P, Bruno B, Passera R, Musto P, Boccadoro M, Sonneveld P, Palumbo A. Complete response correlates with long-term progression-free and overall survival in elderly myeloma treated with novel agents: analysis of 1175 patients. Blood. 2011 Mar 17;117(11):3025-31. doi: 10.1182/blood-2010-09-307645. Epub 2011 Jan 12.

    PMID: 21228328DERIVED

  • Palumbo A, Bringhen S, Liberati AM, Caravita T, Falcone A, Callea V, Montanaro M, Ria R, Capaldi A, Zambello R, Benevolo G, Derudas D, Dore F, Cavallo F, Gay F, Falco P, Ciccone G, Musto P, Cavo M, Boccadoro M. Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial. Blood. 2008 Oct 15;112(8):3107-14. doi: 10.1182/blood-2008-04-149427. Epub 2008 May 27.

    PMID: 18505783DERIVED

  • Palumbo A, Bringhen S, Caravita T, Merla E, Capparella V, Callea V, Cangialosi C, Grasso M, Rossini F, Galli M, Catalano L, Zamagni E, Petrucci MT, De Stefano V, Ceccarelli M, Ambrosini MT, Avonto I, Falco P, Ciccone G, Liberati AM, Musto P, Boccadoro M; Italian Multiple Myeloma Network, GIMEMA. Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial. Lancet. 2006 Mar 11;367(9513):825-31. doi: 10.1016/S0140-6736(06)68338-4.

    PMID: 16530576DERIVED

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma CellDisease

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mario Boccadoro, MD

    Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy

    PRINCIPAL INVESTIGATOR

  • Antonio Palumbo, MD

    Divisione di Ematologia dell'Università degli Studi di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy

    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

October 4, 2005

First Posted

October 5, 2005

Study Start

January 1, 2002

Primary Completion

January 1, 2005

Study Completion

November 1, 2014

Last Updated

August 2, 2018

Record last verified: 2018-08

Locations

IT(13)