Back to resultsComparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma (IFM 01/01)
Primary Purpose
Newly Diagnosed, Multiple Myeloma
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Thalidomide
melphalan, prednisone
melphalan, prednisone, thalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Newly Diagnosed, Multiple Myeloma focused on measuring Multiple Myeloma, very elderly patients, thalidomide
Eligibility 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.
Sites / Locations
- CHU Nancy - Brabois, rue du morvan
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
A
B
Arm Description
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
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
Outcomes
Primary Outcome Measures
overall Survival
Secondary Outcome Measures
Progression Free Survival
Response rates
Safety
Full Information
NCT ID
NCT00644306
First Posted
March 20, 2008
Last Updated
March 20, 2008
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT00644306
Brief Title
Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Terminated
Why Stopped
survival advantage demonstrated
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newly Diagnosed, Multiple Myeloma
Keywords
Multiple Myeloma, very elderly patients, thalidomide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
232 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
B
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Description
100 mg/day continuously for 18 months
Intervention Type
Drug
Intervention Name(s)
melphalan, prednisone
Other Intervention Name(s)
Alkeran, cortancyl
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
melphalan, prednisone, thalidomide
Other Intervention Name(s)
Alkeran, cortancyl
Intervention Description
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
Primary Outcome Measure Information:
Title
overall Survival
Time Frame
May 2007
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
May 2007
Title
Response rates
Time Frame
May 2007
Title
Safety
Time Frame
May 2007
10. Eligibility
Sex
All
Minimum 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cyrille Hulin, MD
Organizational Affiliation
Hematology CHU Nancy and Intergroupe Francophone du Myelome (IFM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nancy - Brabois, rue du morvan
City
Vandoeuvre
ZIP/Postal Code
54511
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.
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Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma
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