Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma - Full Text View

Sponsored by:	University Hospital, Lille
Information provided by:	University Hospital, Lille
ClinicalTrials.gov Identifier:	NCT00367185

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Drug: Thalidomide	Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Prednisone Melphalan Thalidomide Melphalan hydrochloride Sarcolysin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
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.

Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:

Overall survival

Secondary Outcome Measures:

Best response rate
Progression-free survival
Survival after progression
Toxicity

Estimated Enrollment:	500
Study Start Date:	May 2000
Estimated Study Completion Date:	October 2005

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.

Eligibility

Ages Eligible for Study:	65 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367185

Locations

France
Lille University Hospital
Lille, France, 59037

Sponsors and Collaborators

University Hospital, Lille

Investigators

Study Director:

Jean-Yves MARY

U717 INSERM universite Paris7, Hopital Saint-Louis, Paris, France

More Information

Publications indexed to this study:

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.

Study ID Numbers:	IFM 99-06
Study First Received:	August 21, 2006
Last Updated:	August 21, 2006
ClinicalTrials.gov Identifier:	NCT00367185
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Lille:

Multiple myeloma
Elderly patients
Thalidomide
Autologous transplantation

Study placed in the following topic categories:

Melphalan
Prednisone
Immunoproliferative Disorders
Thalidomide
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases

Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents
Angiogenesis Inhibitors

Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on January 16, 2009