IFM 99-02 Thalidomide in Myeloma

Multiple Myeloma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222053
• Other study ID #: PHRC 98-45-N
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2005
• Last updated: April 1, 2010
• Start date: April 2000
• Est. completion date: December 2009

Study information

• Verified date: April 2010
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma

Intervention

Drug:
• Thalidomide
Per os thalidomide
• Biphosphonates
Biphosphonates

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (2)

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 Français du Myélome. N Engl J Med. 1996 Jul 11;335(2):91-7. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of response		3 years	No
Secondary	Survival		3 years	Yes
Secondary	Toxicity		3 years	Yes