Trial Details
Trial status:
Recruitment start date:
Cancer Research UK
Chief Investigator:
Rebecca Auer
Recruitment target:
EudraCT number:
Contact details:
Lay summary:
Randomised phase 2 trial in WM - Subcutaneous Bortezomib, Clycophosphamide and Rituximab (BCR versus Fludarabine, Cyclophosphamide and Rituximab (FCR) for initial therapy of Waldenstr?m’s macroglobulinaemia (WM): a randomised phase II trial
Design: R2W is a randomised (2:1), non-comparative, multicentre, phase II trial  of bortezomib, cyclophosphamide and rituximab (BCR – experimental) versus fludarabine, cyclophosphamide and rituximab (FCR – control) for initial therapy in patients with symptomatic untreated Waldenstrom’s macroglobulinaemia (WM); using a three-outcome design for the experimental arm.
Treatment: Patients are treated with BCR or FCR (in accordance with the arm to which they are randomised) for 3 cycles when response to treatment is assessed. Those with evidence of progression stop trial treatment. All other patients continue with further 3 cycles (to a total of 6) unless a clear clinical contraindication to further treatment exists.
Key inclusion/exclusion criteria:

  • Age ≥18 years 
  • Performance status 0-2
  • Life expectancy >6 months
  • Confirmed diagnosis of WM with measurable IgM paraprotein
  • Previously untreated disease at any stage requiring therapy at the discretion of the treating physician
  • No previous chemotherapy 

  • Lymphoplasmacytic lymphoma with no detectable serum IgM paraprotein
  • Severe pre-existing neuropathy (> grade 2) 
  • Autoimmune cytopenias
  • Evidence of active Hepatitis B or C infection, or HIV
  • Pregnant or lactating women
  • Life expectancy severely limited by other illness
  • Inadequate renal and liver function
  • History of allergic reaction to compounds containing boron or mannitol
  • Known hypersensitivity to murine compounds
  • Diagnosed or treated for a malignancy other than WM within 5 years (with exceptions)
  • Active systemic infection requiring treatment
  • Concurrent treatment with another investigational agent
  • Severe or life-threatening cardiac, pulmonary, neurological, psychiatric or metabolic disease

Duration of recruitment: 3 years
The primary objective of the study is to make a preliminary examination of the efficacy and safety of the proposed Bortezomib, Cyclophosphamide and Rituximab regimen for previously untreated patients with Waldenstrom’s macroglobulinaemia and to determine whether this regimen warrants further investigation in the randomised phase III setting. 
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
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