Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma - Tabular View

Tracking Information

First Received Date ^ICMJE

August 21, 2006

Last Updated Date

August 21, 2006

Start Date ^ICMJE

May 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Overall survival

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Best response rate
Progression-free survival
Survival after progression
Toxicity

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma

Official Title ^ICMJE

Comparison of Melphalan-Prednisone(MP),MP-THALIDOMIDE,and Autologous Stem Cell Transplantation in the Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma.

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.

Detailed Description

Trial design This multicenter, randomized, controlled trial is conducted by the French Myeloma Intergroup(IFM) in elderly patients with previously untreated multiple myeloma. The primary objectives of the study are to compare the efficacy and safety of MP with MP-Thalidomide or with MEL100 (intermediate-dose melphalan 100 mg/m2 - based treatment). The secondary objective is to compare the efficacy of MP-Thalidomide vs MEL100.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Multiple Myeloma

Intervention ^ICMJE

Drug: Thalidomide

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

500

Completion Date

October 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

65 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00367185

Responsible Party

Study ID Numbers ^ICMJE

IFM 99-06

Study Sponsor ^ICMJE

University Hospital, Lille

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Jean-Yves MARY

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

Information Provided By

University Hospital, Lille

Verification Date

April 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP