Clinical trial · Interventional
IFM 99-02 Thalidomide in Myeloma
NCT00222053CI-TRIAL-00003327completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biphosphonates | Drug | — | UNRESOLVED |
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- 1
- description
- No specific intervention
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Biphosphonates
- interventionNames
- Drug: Biphosphonates
- type
- EXPERIMENTAL
- label
- 3
- description
- Thalidomide
- interventionNames
- Drug: Thalidomide
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDCombination 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 9850028
- BACKGROUNDAttal 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 8649495