Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Thalidomide Plus Dexamethasone Compared With Dexamethasone As Initial Therapy for Newly Diagnosed Multiple Myeloma

• DOI: 10.1200/jco.2007.14.1853
• Publication Date: 2008-03-25T00:44:51Z
• Authors: S. Vincent Rajkumar; Laura Rosiñol; Mohamad Hussein; John Catalano; Wieslaw Jedrzejczak; Lela Lucy; Marta Olesnyckyj; Zhinuan Yu; Robert Knight; Jerome B. Zeldis; Joan Bladé
• Keywords: Adult; Aged, 80 and over; Male; Time Factors; Australia; Administration, Oral; Kaplan-Meier Estimate; Middle Aged; Dexamethasone; Drug Administration Schedule; Thalidomide; 3. Good health; Europe; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Double-Blind Method; Antineoplastic Combined Chemotherapy Protocols; Disease Progression; Humans; Female; Multiple Myeloma; Aged

The long-term impact of thalidomide plus dexamethasone (thal/dex) as primary therapy for newly diagnosed multiple myeloma (MM) is unknown. goal this study was to compare versus placebo (placebo/dex)as MM.In double-blind, placebo-controlled trial, patients with untreated symptomatic MM were randomized thal/dex (arm A) or (dex) B). Patients in arm A received oral 50 mg daily, escalated 100 on day 15, and 200 from 1 cycle 2 (28-day cycles). Oral dex 40 administered days through 4, 9 12, 17 20 during cycles 4 only 5 onwards. B dex, A. end point the time progression. This registered at http://ClinicalTrials.gov (NCT00057564).A total 470 enrolled (235 randomly assigned 235 placebo/dex). overall response rate significantly higher compared placebo/dex (63% v 46%), P < .001. Time progression (TTP) longer (median, 22.6 6.5 months, .001). Grade adverse events more frequent than (30.3% 22.8%).Thal/dex results rates prolongs TTP alone MM.