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Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure.
- Source :
-
Blood [Blood] 2008 Dec 01; Vol. 112 (12), pp. 4445-51. Date of Electronic Publication: 2008 Sep 17. - Publication Year :
- 2008
-
Abstract
- This analysis assessed the efficacy and safety of lenalidomide + dexamethasone in patients with relapsed or refractory multiple myeloma (MM) previously treated with thalidomide. Of 704 patients, 39% were thalidomide exposed. Thalidomide-exposed patients had more prior lines of therapy and longer duration of myeloma than thalidomide-naive patients. Lenalidomide + dexamethasone led to higher overall response rate (ORR), longer time to progression (TTP), and progression-free survival (PFS) versus placebo + dexamethasone despite prior thalidomide exposure. Among lenalidomide + dexamethasone-treated patients, ORR was higher in thalidomide-naive versus thalidomide-exposed patients (P = .04), with longer median TTP (P = .04) and PFS (P = .02). Likewise for dexamethasone alone-treated patients (P = .03 for ORR, P = .03 for TTP, P = .06 for PFS). Prior thalidomide did not affect survival in lenalidomide + dexamethasone-treated patients (36.1 vs 33.3 months, P > .05). Thalidomide-naive and thalidomide-exposed patients had similar toxicities. Lenalidomide + dexamethasone resulted in higher rates of venous thromboembolism, myelosuppression, and infections versus placebo + dexamethasone, independent of prior thalidomide exposure. Lenalido-mide + dexamethasone was superior to placebo + dexamethasone, independent of prior thalidomide exposure. Although prior thalidomide may have contributed to inferior TTP and PFS compared with thalidomide-naive patients, these parameters remained superior compared with placebo + dexamethasone; similar benefits compared with placebo + dexamethasone were not evident for thalidomide-exposed patients in terms of overall survival. Studies were registered at http://www.clinicaltrials.gov under NCT00056160 and NCT00424047.
- Subjects :
- Antineoplastic Combined Chemotherapy Protocols adverse effects
Chemotherapy, Adjuvant
Clinical Trials, Phase III as Topic
Dexamethasone adverse effects
Dose-Response Relationship, Drug
Humans
Lenalidomide
Middle Aged
Multiple Myeloma mortality
Placebos
Randomized Controlled Trials as Topic
Recurrence
Retrospective Studies
Survival Analysis
Thalidomide administration & dosage
Thalidomide adverse effects
Treatment Outcome
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Dexamethasone administration & dosage
Drug Resistance, Neoplasm drug effects
Multiple Myeloma drug therapy
Thalidomide analogs & derivatives
Thalidomide therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1528-0020
- Volume :
- 112
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- Blood
- Publication Type :
- Academic Journal
- Accession number :
- 18799726
- Full Text :
- https://doi.org/10.1182/blood-2008-02-141614