Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367185
• Other study ID #: IFM 99-06
• Status: Completed
• Phase: Phase 3
• First received: August 21, 2006
• Last updated: August 21, 2006
• Start date: May 2000
• Est. completion date: October 2005

Study information

• Verified date: April 2006
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Thalidomide

Locations

Country	Name	City	State
France	Lille University Hospital	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival
Secondary	Best response rate
Secondary	Progression-free survival
Secondary	Survival after progression
Secondary	Toxicity