Back to resultsTreatment of Newly Diagnosed Elderly Patients With Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma, Elderly patients, Thalidomide, Autologous transplantation
Eligibility 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
Sites / Locations
- Lille University Hospital
Outcomes
Primary Outcome Measures
Overall survival
Secondary Outcome Measures
Best response rate
Progression-free survival
Survival after progression
Toxicity
Full Information
NCT ID
NCT00367185
First Posted
August 21, 2006
Last Updated
August 21, 2006
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT00367185
Brief Title
Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Lille
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple myeloma, Elderly patients, Thalidomide, Autologous transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Primary Outcome Measure Information:
Title
Overall survival
Secondary Outcome Measure Information:
Title
Best response rate
Title
Progression-free survival
Title
Survival after progression
Title
Toxicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Yves MARY
Organizational Affiliation
U717 INSERM universite Paris7, Hopital Saint-Louis, Paris, France
Official's Role
Study Director
Facility Information:
Facility Name
Lille University Hospital
City
Lille
ZIP/Postal Code
59037
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
17920916
Citation
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. doi: 10.1016/S0140-6736(07)61537-2.
Results Reference
derived
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Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma
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