Back to resultsIFM 99-02 Thalidomide in Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Thalidomide
Biphosphonates
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Myeloma, Autologous transplantation, Maintenance therapy, Thalidomide
Eligibility Criteria
Inclusion Criteria: de novo myeloma according to Durie and Salmon classification stage II, III and stage I with a lytic bone lesion patients from 18 to 65 years old beta2microglobulin < 3 mg/l or del13 absent signed informed consent eligible for transplantation Exclusion Criteria: peripheral neurological toxicities uncontrolled or severe cardiovascular disease other malignancy except basocellular carcinoma or FIGO stage I carcinoma of the cervix patient who received biphosphonate during the last 60 days renal failure definited as creatinine > 150 µmol/l patient with obvious vascular cerebral medical history liver dysfunction definited as bilirubin > 35 µmol/l or ASAT, ALAT, PAL > 4N respiratory dysfunction HIV + Patient who refused to use an acceptable barrier method for contraception
Sites / Locations
- Médecine Interne, CHU Purpan
- Médecine Interne, Hôpital Rangueil
- Rhumatologie, CHU Purpan
- Rhumatologie, CHU Rangueil
- Service d'hématologie, CHU Purpan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Experimental
Arm Label
1
2
3
Arm Description
No specific intervention
Biphosphonates
Thalidomide
Outcomes
Primary Outcome Measures
Duration of response
Secondary Outcome Measures
Survival
Toxicity
Full Information
NCT ID
NCT00222053
First Posted
September 15, 2005
Last Updated
April 1, 2010
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT00222053
Brief Title
IFM 99-02 Thalidomide in Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Myeloma, Autologous transplantation, Maintenance therapy, Thalidomide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
No specific intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
Biphosphonates
Arm Title
3
Arm Type
Experimental
Arm Description
Thalidomide
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Description
Per os thalidomide
Intervention Type
Drug
Intervention Name(s)
Biphosphonates
Intervention Description
Biphosphonates
Primary Outcome Measure Information:
Title
Duration of response
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Survival
Time Frame
3 years
Title
Toxicity
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
de novo myeloma
according to Durie and Salmon classification stage II, III and stage I with a lytic bone lesion
patients from 18 to 65 years old
beta2microglobulin < 3 mg/l or del13 absent
signed informed consent
eligible for transplantation
Exclusion Criteria:
peripheral neurological toxicities
uncontrolled or severe cardiovascular disease
other malignancy except basocellular carcinoma or FIGO stage I carcinoma of the cervix
patient who received biphosphonate during the last 60 days
renal failure definited as creatinine > 150 µmol/l
patient with obvious vascular cerebral medical history
liver dysfunction definited as bilirubin > 35 µmol/l or ASAT, ALAT, PAL > 4N
respiratory dysfunction
HIV +
Patient who refused to use an acceptable barrier method for contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ATTAL Michel, MD
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Médecine Interne, CHU Purpan
City
Toulouse
Country
France
Facility Name
Médecine Interne, Hôpital Rangueil
City
Toulouse
Country
France
Facility Name
Rhumatologie, CHU Purpan
City
Toulouse
Country
France
Facility Name
Rhumatologie, CHU Rangueil
City
Toulouse
Country
France
Facility Name
Service d'hématologie, CHU Purpan
City
Toulouse
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
9850028
Citation
Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Myeloma Trialists' Collaborative Group. J Clin Oncol. 1998 Dec;16(12):3832-42. doi: 10.1200/JCO.1998.16.12.3832.
Results Reference
background
PubMed Identifier
8649495
Citation
Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, Casassus P, Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med. 1996 Jul 11;335(2):91-7. doi: 10.1056/NEJM199607113350204.
Results Reference
background
Learn more about this trial
IFM 99-02 Thalidomide in Myeloma
We'll reach out to this number within 24 hrs