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

Condition(s) targeted: Newly Diagnosed, Multiple Myeloma

Intervention: Thalidomide (Drug); melphalan, prednisone (Drug); melphalan, prednisone, thalidomide (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Central Hospital, Nancy, France

Official(s) and/or principal investigator(s):
Cyrille Hulin, MD, Principal Investigator, Affiliation: Hematology CHU Nancy and Intergroupe Francophone du Myelome (IFM)

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.

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

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

Primary outcome: overall Survival

Secondary outcome:

Progression Free Survival

Response rates

Safety

Minimum age: 75 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

CHU Nancy - Brabois, rue du morvan, VANDOEUVRE 54511, France

Related publications:

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.

Starting date: April 2002
Ending date: May 2007
Last updated: March 20, 2008