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

Sponsored by:	Central Hospital, Nancy, France
Information provided by:	Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:	NCT00644306

Purpose

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.

Condition	Intervention	Phase
Newly Diagnosed, Multiple Myeloma	Drug: Thalidomide Drug: melphalan, prednisone Drug: melphalan, prednisone, thalidomide	Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Thalidomide Prednisone Melphalan Sarcolysin Melphalan hydrochloride

U.S. FDA Resources

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

Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:

overall Survival [ Time Frame: May 2007 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Progression Free Survival [ Time Frame: May 2007 ] [ Designated as safety issue: No ]
Response rates [ Time Frame: May 2007 ] [ Designated as safety issue: No ]
Safety [ Time Frame: May 2007 ] [ Designated as safety issue: Yes ]

Enrollment:	232
Study Start Date:	April 2002
Study Completion Date:	May 2007

Arms	Assigned Interventions
A: Placebo Comparator 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: 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
B: Active Comparator 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	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

Eligibility

Ages Eligible for Study:	75 Years and older
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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644306

Locations

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

Sponsors and Collaborators

Central Hospital, Nancy, France

Investigators

Principal Investigator:

Cyrille Hulin, MD

Hematology CHU Nancy and Intergroupe Francophone du Myelome (IFM)

More Information

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.

Responsible Party:	Intergroupe Francophone du Myélome (IFM) ( Hulin Cyrille )
Study ID Numbers:	University Hospital, Nancy
Study First Received:	March 20, 2008
Last Updated:	March 20, 2008
ClinicalTrials.gov Identifier:	NCT00644306 History of Changes
Health Authority:	France: French Agency of Health Security and Drugs Products

Keywords provided by Central Hospital, Nancy, France:

Multiple Myeloma, very elderly patients, thalidomide

Study placed in the following topic categories:

Anti-Inflammatory Agents
Prednisone
Melphalan
Thalidomide
Immunologic Factors
Blood Protein Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Paraproteinemias
Hemostatic Disorders
Hormones
Anti-Bacterial Agents
Hemorrhagic Disorders

Alkylating Agents
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Angiogenesis Inhibitors
Immunosuppressive Agents
Glucocorticoids
Multiple Myeloma
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Melphalan
Prednisone
Molecular Mechanisms of Pharmacological Action
Thalidomide
Immunologic Factors
Blood Protein Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Paraproteinemias
Hemostatic Disorders
Hormones
Anti-Bacterial Agents

Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Growth Substances
Vascular Diseases
Angiogenesis Inhibitors
Glucocorticoids

ClinicalTrials.gov processed this record on May 07, 2009