Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Thalidomide Plus Dexamethasone Compared With Dexamethasone As Initial Therapy for Newly Diagnosed Multiple Myeloma
| Autor: | Joan Bladé, Wiesław Wiktor Jędrzejczak, Zhinuan Yu, Mohamad A. Hussein, Jerome B. Zeldis, S. Vincent Rajkumar, Lela M. Lucy, Marta Olesnyckyj, Laura Rosiñol, John G. Catalano, Rob Knight |
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| Rok vydání: | 2008 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Time Factors Randomization medicine.drug_class Placebo-controlled study Administration Oral Kaplan-Meier Estimate Placebo Gastroenterology Article Dexamethasone Drug Administration Schedule Double-Blind Method Internal medicine Antineoplastic Combined Chemotherapy Protocols polycyclic compounds medicine Clinical endpoint Humans Multiple myeloma Aged Aged 80 and over business.industry Australia Middle Aged medicine.disease United States Thalidomide Surgery Europe Treatment Outcome Oncology Disease Progression Corticosteroid Female Multiple Myeloma business hormones hormone substitutes and hormone antagonists medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 26:2171-2177 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2007.14.1853 |
| Popis: | Purpose The long-term impact of thalidomide plus dexamethasone (thal/dex) as primary therapy for newly diagnosed multiple myeloma (MM) is unknown. The goal of this study was to compare thalidomide plus dexamethasone versus placebo plus dexamethasone (placebo/dex)as primary therapy for newly diagnosed MM. Patients and Methods In this double-blind, placebo-controlled trial, patients with untreated symptomatic MM were randomized to thal/dex (arm A) or to placebo plus dexamethasone (dex) (arm B). Patients in arm A received oral thalidomide 50 mg daily, escalated to 100 mg on day 15, and to 200 mg from day 1 of cycle 2 (28-day cycles). Oral dex 40 mg was administered on days 1 through 4, 9 through 12, and 17 through 20 during cycles 1 through 4 and on days 1 through 4 only from cycle 5 onwards. Patients in arm B received placebo and dex, administered as in arm A. The primary end point of the study was time to progression. This study is registered at http://ClinicalTrials.gov ( NCT00057564 ). Results A total of 470 patients were enrolled (235 randomly assigned to thal/dex and 235 to placebo/dex). The overall response rate was significantly higher with thal/dex compared with placebo/dex (63% v 46%), P < .001. Time to progression (TTP) was significantly longer with thal/dex compared with placebo/dex (median, 22.6 v 6.5 months, P < .001). Grade 4 adverse events were more frequent with thal/dex than with placebo/dex (30.3% v 22.8%). Conclusion Thal/dex results in significantly higher response rates and significantly prolongs TTP compared with dexamethasone alone in patients with newly diagnosed MM. |
| Databáze: | OpenAIRE |
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