Official Title: “Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma”

In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been usedsince the 1960s and is regarded as the standard of care in very elderly patients. We assess whether the addition of thalidomide at 100 mg/day to this combination would improve survival.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Thalidomide
  • 100 mg/day continuously for 18 months
• Drug: melphalan, prednisone
  • 12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months
• Drug: melphalan, prednisone, thalidomide
  • 12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: A
  • 12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months
• Active Comparator: B
  • 12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months

Primary Measures

• overall Survival
  • Time Frame: May 2007
    Safety Issue?: Yes

Secondary Measures

• Progression Free Survival
  • Time Frame: May 2007
    Safety Issue?: No
• Response rates
  • Time Frame: May 2007
    Safety Issue?: No
• Safety
  • Time Frame: May 2007
    Safety Issue?: Yes

Inclusion Criteria:

• Stage II or III multiple myeloma according to Durie and Salmon criteria, patients older than 75 years, previously untreated patients.

Exclusion Criteria:

• Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma)
• Primary or associated amyloïdosis
• 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 clinically significant
• History of venous thrombosis during the last 6 months
• HIV or hepatitis B or C positivity
• Patients who had geography, social, or psychological conditions which might prevent adequate follow-up.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 75 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Central Hospital, Nancy, France

Overall Clinical Trial Officials and Contacts

Cyrille Hulin, MD Principal Investigator Hematology CHU Nancy and Intergroupe Francophone du Myelome (IFM)  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00644306

Study ID Number: University Hospital, Nancy

ClinicalTrials.gov Identifier: NCT00644306

Health Authority: France: French Agency of Health Security and Drugs Products