IFM 99-02 Thalidomide in Myeloma
1 other identifier
interventional
800
1 country
5
Brief Summary
Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Apr 2000
Longer than P75 for phase_3 multiple-myeloma
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 15, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedApril 2, 2010
April 1, 2010
9.4 years
September 15, 2005
April 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of response
3 years
Secondary Outcomes (2)
Survival
3 years
Toxicity
3 years
Study Arms (3)
1
NO INTERVENTIONNo specific intervention
2
ACTIVE COMPARATORBiphosphonates
3
EXPERIMENTALThalidomide
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Médecine Interne, CHU Purpan
Toulouse, France
Médecine Interne, Hôpital Rangueil
Toulouse, France
Rhumatologie, CHU Purpan
Toulouse, France
Rhumatologie, CHU Rangueil
Toulouse, France
Service d'hématologie, CHU Purpan
Toulouse, France
Related Publications (2)
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.
PMID: 9850028BACKGROUNDAttal 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.
PMID: 8649495BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ATTAL Michel, MD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 15, 2005
First Posted
September 22, 2005
Study Start
April 1, 2000
Primary Completion
September 1, 2009
Study Completion
December 1, 2009
Last Updated
April 2, 2010
Record last verified: 2010-04