Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia

Conditions

• Waldenstrom's Macroglobulinemia

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Bortezomib — DRUG
  1.6 mg/m\^2 IV Weekly on Days 1, 8, 15 and 22.
• Rituximab — DRUG
  375 mg/m\^2 IV on Day 8 and 22.
• Valacyclovir — DRUG
  500 mg orally daily (or acyclovir 200 mg orally twice daily)

Study Details

The main goal of this clinical research study is to learn if Velcade ® (bortezomib) given with rituximab can help to control WM. This drug combination will allow researchers to collect your stem cells in case it is possible to transplant the stem cells as treatment if your WM gets worse. Researchers will also look at the safety and tolerability of this drug combination followed by treatment with other drug combinations.

Key Dates

Start date

Aug 2, 2006

Status verified

Feb 2026

Primary completion

Feb 28, 2021

Completion

Jun 28, 2026

Study Design

Enrollment

46 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Bortezomib + Rituximab
  Bortezomib 1.6 mg/m\^2 IV Weekly on Days 1, 8, 15 and 22. Rituximab 375 mg/m\^2 IV on Day 8 and 22. Valacyclovir 500 mg orally daily (or acyclovir 200 mg orally twice daily).

Primary Outcome Measure

Response Rate After 2 Cycles of Treatment With Bortezomib and Rituximab [ Time Frame: After 2 (35 day) cycles of treatment ]

Locations (1)

Find similar trials in Houston, TX