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CompletedNCT00142129Updated Jun 27, 2011

Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia

A Phase 2 interventional study of Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia and Lymphoplasmacytic Lymphoma, sponsored by Dana-Farber Cancer Institute. Completed at 2 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2011-06-27.

Sponsored by Dana-Farber Cancer Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
27
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate how tumors in patients with Waldenstrom's macroglobulinemia respond to treatment with bortezomib (Velcade) and to see what effects (good and bad) it has on the cancer.

Read the detailed description
  • Patients will receive bortezomib intravenously twice weekly for 2 weeks on days 1,4,8 and 11 of each cycle. A 10-day rest period (days 12-21) will follow the 2 weeks of treatment. The treatment cycle is repeated up to eight times depending upon the disease response and if the patient is tolerating the drugs.
  • The following procedures will be conducted as part of the treatment monitoring: DAY 1 VISIT (of each treatment cycle): evaluation of disease-related symptoms, vital signs and weight and blood tests. DAY 4 VISIT (of each treatment cycle): vital signs and blood work. DAY 8 VISIT (of each treatment cycle): vital signs and blood work. DAY 11 VISIT(of each treatment cycle): vital signs, blood work, and possible CT Scan.
  • Treatment will be discontinued if any of the following occur: Disease gets worse, severe side-effects or the patient requires other anti-cancer therapy.
  • At the end of the treatment (30 days after the last dose of study drug) the patient will have a physical exam, vital signs, evaluation of disease-related symptoms, blood work and CT scan for tumor measurements.
  • Long term follow-up consists of every 3 month clinical visits until disease progression or up to 2 years.
02

Conditions studied

  • Waldenstrom's Macroglobulinemia
  • Lymphoplasmacytic Lymphoma

Keywords

  • bortezomib
  • Velcade
  • Waldenstrom's macroglobulinemia
03

In context

Waldenstrom Macroglobulinemia

365 studies on the registry are indexed under Waldenstrom Macroglobulinemia; 62 are open to participants now.

This study's enrollment of 27 is below the median of 40 across 316 interventional studies indexed under Waldenstrom Macroglobulinemia.

Browse Waldenstrom Macroglobulinemia studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinicopathological diagnosis of Waldenstrom's macroglobulinemia who have failed one first line therapy
  • Measurable disease, defined as presence of immunoglobulin M (Ig M) paraprotein with a minimum IgM level of >2 times ULN
  • Karnofsky performance status of >60
  • Life expectancy of > 3 months
  • Baseline platelet count >50,000,000,000/L and ANC of 750,000,000/L
  • AST and ALT \< 3 x ULN
  • Total bilirubin \< 2 x ULN
  • Calculated or measured creatinine clearance > 30mL/minute
  • Serum sodium > 130 mmol/L

Exclusion criteria

Exclusion Criteria:

  • Greater than or equal to Grade 2 peripheral neuropathy
  • Hypersensitivity to bortezomib, boron or mannitol
  • Prior therapy with Velcade
  • Pregnant or lactating women
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants

Interventions

  • DrugBortezomib (Velcade)
06

What researchers measure

Primary outcomes

  1. To determine response rate along with attainment of stable disease following treatment with bortezomib in patients with Waldenstrom's macroglobulinemia.

Secondary outcomes

  1. To assess the safety and tolerability of bortezomib in this patient population.

07

Study locations

2 sites
  • Dana-Farber Cancer Center
    Boston, Massachusetts 02115, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00142129
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Millennium Pharmaceuticals, Inc.
First posted
Sep 2, 2005
Start date
Dec 2003
Primary completion
Jun 2007
Completion
Jun 2007
Last update
Jun 27, 2011

Study contacts

Steven Treon, MD, MA, PhD
principal investigator · Dana-Farber Cancer Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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