Bortezomib, Dexamethasone, and Rituximab in Previously Untreated Patients With Waldenstrom's Macroglobulinemia
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|ClinicalTrials.gov Identifier: NCT01046006|
Recruitment Status : Unknown
Verified January 2014 by Meletios A. Dimopoulos, University of Athens.
Recruitment status was: Active, not recruiting
First Posted : January 11, 2010
Last Update Posted : January 31, 2014
|Condition or disease||Intervention/treatment||Phase|
|Waldenstrom's Macroglobulinemia||Drug: Bortezomib, Rituximab, Dexamethasone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Combination Bortezomib, Dexamethasone, and Rituximab in Previously Untreated Patients With Waldenstrom's Macroglobulinemia: A Multicenter Trial of the European Myeloma Network|
|Study Start Date :||March 2007|
|Estimated Primary Completion Date :||February 2014|
BDR will be administered in one 21-day treatment cycle followed by four 35-day treatment cycles to patients with WM. Bortezomib will be administered as an iv push over 3 to 5 seconds at a dose of 1.3mg/m2/day on days 1,4,8 and 11 of cycle 1. On cycles 2-5 bortezomib will be given at a dose of 1.6mg/m2/day on days 1,8,15 and 22 of each cycle. Only on cycles 2 and 5, following the administration of Bortezomib, dexamethasone 40mg iv and Rituximab 375 mg/m2 iv will be administered. A total of 8 infusions of rituximab will be administered. Subsequently patients rated as CR, PR, MR or SD will be followed without any treatment until there is evidence of progressive disease.
Drug: Bortezomib, Rituximab, Dexamethasone
Bortezomib as an iv push over 3 to 5 seconds at a dose of 1.3mg/m2/day on days 1,4,8 and 11 of cycle 1.
On cycles 2-5 bortezomib will be given at a dose of 1.6mg/m2/day on days 1,8,15 and 22 of each 35-day cycle.
Dexamethasone IV 40 mg will be given on cycles 2 and 5 on days 1,8,15,22 Rituximab IV will be given on cycles 2 and 5, 375 mg/m2, on days 1,8,15,22 iv
- To determine the response rate [the combined complete response (CR) + partial response (PR) + minimal response (MR)] following treatment with BDR in patients with previously untreated WM. [ Time Frame: Every cycle while on active therapy and thereafter every 3 to 4 months for up to 2 years, or until progression of disease is documented. ]
- determine time to progression and assess the safety and tolerability of BDR in patients with WM. [ Time Frame: Every cycle while on active therapy and thereafter every 3 to 4 months for up to 2 years, or until progression of disease is documented. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046006
|Alexandra Hospital , Department of Clinical Therapeutics|
|Athens, Attica, Greece, 115 28|
|Athens, Attica, Greece, 11528|
|Erasmus Medical Center|
|Rotterdam, Netherlands, 3015 CE|
|Hospital Universitario de Salamanca|
|Salamanca, Spain, 37007|
|Principal Investigator:||Meletios A Dimopoulos, MD||University of Athens, School of Medicine|