Phase II trial of weekly bortezomib in combination with rituximab in untreated patients with Waldenström Macroglobulinemia

Irene M. Ghobrial, Wanling Xie, Swaminathan Padmanabhan, Ashraf Badros, Meghan Rourke, Renee Leduc, Stacey Chuma, Janet Kunsman, Diane Warren, Tiffany Poon, Brianna Harris, Amy Sam, Kenneth C. Anderson, Paul G. Richardson, Steven P. Treon, Edie Weller, Jeffrey Matous

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128 Scopus citations


This study aimed to determine the activity and safety of weekly bortezomib and rituximab in patients with untreated Waldenström Macroglobulinemia (WM). Patients with no prior therapy and symptomatic disease were eligible. Patients received bortezomib IV weekly at 1.6 mg/m2 on days 1, 8, 15, q 28 days × 6 cycles, and rituximab 375 mg/m2 weekly on cycles 1 and 4. Primary endpoint was the percent of patients with at least a minor response (MR). Twenty-six patients were treated. At least MR was observed in 23/26 patients (88%) (95% CI: 70-98%) with 1 complete response (4%), 1 near-complete response (4%), 15 partial remission (58%), and 6 MR (23%). Using IgM response evaluated by nephlometry, all 26 patients (100%) achieved at least MR or better. The median time to progression has not been reached, with an estimated 1-year event free rate of 79% (95% CI: 53, 91%). Common grade 3 and 4 therapy related adverse events included reversible neutropenia in 12%, anemia in 8%, and thrombocytopenia in 8%. No grade 3 or 4 neuropathy occurred. The combination of weekly bortezomib and rituximab exhibited significant activity and minimal neurological toxicity in patients with untreated WM.

Original languageEnglish (US)
Pages (from-to)670-674
Number of pages5
JournalAmerican Journal of Hematology
Issue number9
StatePublished - Sep 2010

ASJC Scopus subject areas

  • Hematology


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