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

Newly Diagnosed, Multiple Myeloma Clinical Trial

— IFM 01/01  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00644306
• Other study ID #: University Hospital, Nancy
• Status: Terminated
• Phase: Phase 3
• First received: March 20, 2008
• Last updated: March 20, 2008
• Start date: April 2002
• Est. completion date: May 2007

Study information

• Verified date: March 2008
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Agency of Health Security and Drugs Products
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 232
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Newly Diagnosed, Multiple Myeloma

Intervention

Drug:
• Thalidomide
100 mg/day continuously for 18 months
• 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
• 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

Locations

Country	Name	City	State
France	CHU Nancy - Brabois, rue du morvan	Vandoeuvre

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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 Myélome. 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall Survival		May 2007	Yes
Secondary	Progression Free Survival		May 2007	No
Secondary	Response rates		May 2007	No
Secondary	Safety		May 2007	Yes