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Ibrutinib in previously treated Waldenström´s macroglobulinemia.

Treon SP1, Tripsas CK, Meid K, Warren D, Varma G, Green R, Argyropoulos KV, Yang G, Cao Y, Xu L, Patterson CJ, Rodig S, Zehnder JL, Aster JC, Harris NL,Kanan S, Ghobrial I, Castillo JJ, Laubach JP, Hunter ZR, Salman Z, Li J, Cheng M, Clow F, Graef T, Palomba ML, Advani RH.
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Treatment recommendations for patients with Waldenström macroglobulinemia (WM) and related disorders: IWWM-7 consensus.

Dimopoulos MA1, Kastritis E1, Owen RG2, Kyle RA3, Landgren O4, Morra E5, Leleu X6, García-Sanz R7, Munshi N8, Anderson KC8, Terpos E1, Ghobrial IM8,Morel P9, Maloney D10, Rummel M11, Leblond V12, Advani RH13, Gertz MA3, Kyriakou C14, Thomas SK15, Barlogie B16, Gregory SA17, Kimby E18, Merlini G19,Treon SP8.
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Clinical Trials

First line Treatment of WM


The ECWM has launched sucessfully its clinical trial program with the initiation of the ‚ECWM-1‘ trial for first – line treatment of WM patients in need of treatment. In this large phase III European trial it will be tested whether the addition of Bortezomib s.c (B-DRC). further improves the highly effective and non-myelosuppressive immunochemotherapy DRC (Dexamethason, Rituximab and Cyclophosphamide). This trial is already initiated in Germany and has recruited the first patients. It will offer to all patients a modern, highly effective and well tolerated treatment, which will not need anymore i.v. application after a pre-planned amendment later this year, offering Rituximab and Bortezomib s.c., and dexamethasone and cyclophosphamide as oral medication.


The trial design is shown here:



Salvage Treatment of WM


The ECWM participates in the ECWM-R1 (PCYC-1127-CA trial), which offers patients with relapsed WM in need of treatment the highly innovative chemotherapy-free combination of Rituximab/Ibrutinib. In this trial patients are randomized between Rituximab/Placebo and Rituximab/Ibrutinib. Importantly, patients who suffer from progress in the Rituximab/Placebo treatment arm, all have the chance to be treated with Ibrutinib in a cross-over within the trial. This study is an international multi-center trial with most of the participating centers from the ECWM.


The trial design is shown here: