Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia

Conditions

• Waldenstrom's Macroglobulinemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bortezomib — DRUG
  Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles
• Dexamethasone — DRUG
  Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles
• Rituximab — DRUG
  Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles

Study Details

The purpose of this study is to find out if the combination of bortezomib (Velcade), dexamethasone (Decadron) and rituximab (Rituxan) is effective in treating Waldenstrom's macroglobulinemia.

Key Dates

Start date

Oct 31, 2005

Status verified

Mar 2016

Primary completion

Mar 31, 2007

Completion

Feb 28, 2009

Study Design

Enrollment

23 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Bortezomib, Dexamethasone, Rituximab
  A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: 33.2 months ]

Locations (2)

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