Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT00367185
First received: August 21, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted

August 21, 2006
August 21, 2006
May 2000
Not Provided
Overall survival
Same as current
No Changes Posted
  • Best response rate
  • Progression-free survival
  • Survival after progression
  • Toxicity
Same as current
Not Provided
Not Provided
 
Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma
Comparison of Melphalan-Prednisone(MP),MP-THALIDOMIDE,and Autologous Stem Cell Transplantation in the Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma.

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 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: Thalidomide
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
October 2005
Not Provided

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
Both
65 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00367185
IFM 99-06
Not Provided
Not Provided
University Hospital, Lille
Not Provided
Study Director: Jean-Yves MARY U717 INSERM universite Paris7, Hopital Saint-Louis, Paris, France
University Hospital, Lille
April 2006

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