This is a prospective, multicenter phase II trial designed to determine efficacy and safety of Bortezomib plus Rituximab plus Bendamustine in patients with relapsed/refractory Waldenstrom's Macroglobulinemia.
The progression free survival (PFS) expected for lymphoplasmacytic/lymphoplasmocytoid lymphoma/Waldenstrom macroglobulinemia with the same characteristics indicated into the study and treated with standard Rituximab plus chemotherapy may be estimated to be 50% at 18 months. The Investigators would consider a positive result to increase 18 months-PFS rate from 50 to 65%.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Bortezomib-Rituximab-Bendamustine Bortezomib: 1.3 mg/mq sc days 1, 8, 15, 22\* Rituximab: 375 mg/sqm i.v. day 1\*\* Bendamustine: 90 mg/sqm iv days 1-2 or days 2-3 according to institutional/physician choice Repeat cycles every 28 days for a total of 6 cycles \*In case of toxicity is omitted \*\*In cycles 1, in order to avoid tumor lysis syndrome, Rituximab will be given on day 8
AO Riuniti Papardo Piemonte
Messina, ME, Italy
Progression Free Survival (PFS)
This is a prospective, multicenter phase II trial designed to determine efficacy and safety of Bortezomib plus Rituximab plus Bendamustine in patients with relapsed/refractory Waldenstrom's Macroglobulinemia. Primary Objective is to assess whether the experimental treatment achieves an absolute increase of PFS rate from 50 to 65% at 18 months with respect to the standard treatment. PFS is measured from the beginning of therapy to the date of disease progression, relapse or death from any cause. Patients without any relapse at the end of the follow-up will be censored at their last assessment date.
Time frame: 18 months
Overall Response Rate (ORR)
Overall response rate (ORR): a patient is defined as a responder if he has a complete or very good partial or partial response, evaluated in based on Waldenstrom macroglobulinemia consensus recommendations of the 6th International Workshop on Waldestrom's macroglobulinemia.
Time frame: 2 years
Overall Survival (OS)
Overall survival (OS): measured from the beginning of therapy to the date of death from any cause. Patients alive at the time of the final analysis will be censored at the date of the last contact. Minimum follow up time required for all patients will be 2 years.
Time frame: 2 years
Toxicity
Toxicity: severe, life- threatening, fatal (grade 3, 4 and 5)
Time frame: 2 years
Number of serious adverse events
Number of serious adverse events are defined according to "Common Terminology Criteria for Adverse Events" (CTCAE), version 4.0
Time frame: 2 years
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Centro di Riferimento Oncologico della Basilicata
Rionero in Vulture, PZ, Italy
AUSL di Ravenna
Ravenna, RA, Italy
A.O. Bianchi - Melacrino - Morelli
Reggio Calabria, RC, Italy
Nuovo Regina Margherita
Roma, RM, Italy
Uo Oncoematologia, Po "A.Tortora"
Pagani, Salerno, Italy
Ospedale S. Giacomo di Castelfranco Veneto
Castelfranco Veneto, Treviso, Italy
A.O. SS. Antonio e Biagio e C. Arrigo
Alessandria, Italy
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona
Ancona, Italy
Centro di riferimento Oncologico - Oncologia Medica A
Aviano (PN), Italy
...and 13 more locations