Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma

Phase 3

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT00367185
• Lead Sponsor: University Hospital, Lille

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 Timeline

• Study Start: 2000-05
• Study Completion: 2005-10
• Status Verified: 2006-04
• Study First Submitted: 2006-08-21
• Study First Submitted QC: 2006-08-21
• Last Update Submitted: 2006-08-21
• Study First Posted: 2006-08-22
• Last Update Posted: 2006-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Best response rate
Progression-free survival
Survival after progression
Toxicity

Trial Locations

Locations (1)

Lille University Hospital; 🇫🇷 Lille, France