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CompletedNCT00045695Updated May 17, 2013

Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia

A Phase 2 interventional study of bortezomib in Lymphoma, sponsored by NCIC Clinical Trials Group. Completed at 12 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-17.

Sponsored by NCIC Clinical Trials Group · Phase 2, Interventional, and Treatment

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

Study summary

RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have untreated or relapsed Waldenstrom's macroglobulinemia.

Read the detailed description

OBJECTIVES:

  • Determine the efficacy of bortezomib, in terms of response rate, in patients with previously untreated or relapsed Waldenstrom's macroglobulinemia.
  • Determine the toxicity of this drug in these patients.
  • Determine the time to progression, stable disease duration, and response duration in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks. Patients with complete or partial response or stable disease are followed every 3 months thereafter.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 1.5-2 years.

02

Conditions studied

  • Lymphoma

Keywords

  • Waldenstrom 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

NCIC Clinical Trials Group is the lead sponsor of 114 studies on the registry; none are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 7 (26%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of Waldenstrom's macroglobulinemia confirmed by immunofixation or immunoelectrophoresis

    • Newly diagnosed or untreated with IgM ≥ 20 g/L OR
    • Previously treated with IgM ≥ 5 g/L
  • Non-refractory, defined as no disease progression during prior therapy or within 4 weeks of the last dose of most recent prior therapy (12 weeks for rituximab)
  • Must have 1 or more of the following:

    • Symptomatic lymphadenopathy
    • Hepatomegaly and/or splenomegaly
    • Anemia (i.e., hemoglobin \< 11.0 g/dL)
    • Hyperviscosity syndrome
  • No other lymphoproliferative disease including transformed aggressive lymphoma

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • See Disease Characteristics
  • Absolute granulocyte count ≥ 1,000/mm\^3
  • Platelet count ≥ 50,000/mm\^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST or ALT ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Other

  • No uncontrolled bacterial, fungal, or viral infection
  • No pre-existing sensory or motor neurotoxicity grade 2 or greater
  • No other prior malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor for which patient has been disease free for at least 5 years
  • No other serious illness or medical condition that would preclude study participation
  • No unreasonable geographical limitations
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Chemotherapy
  • See Disease Characteristics
  • At least 12 weeks since prior rituximab (for patients who have progressed)
  • At least 24 weeks since prior rituximab (for patients who have not progressed)
  • No prior high-dose chemotherapy and stem cell transplantation
  • No prior radioactive monoclonal antibodies

Chemotherapy

  • See Disease Characteristics
  • See Biologic therapy
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No more than 2 prior chemotherapy regimens

    • The same chemotherapy combination given for first-line and second-line therapy is considered 2 regimens
    • Single-agent rituximab not considered 1 prior regimen
  • No concurrent cytotoxic chemotherapy

Endocrine therapy

  • No concurrent corticosteroids

Radiotherapy

  • At least 4 weeks since prior radiotherapy (except for low-dose, non- myelosuppressive radiotherapy) and recovered
  • No prior radiotherapy to more than 25% of bone marrow

Surgery

  • At least 4 weeks since prior major surgery

Other

  • At least 4 weeks since prior plasmapheresis
  • At least 4 weeks since prior investigational anticancer therapy
  • No other concurrent investigational anticancer agents or therapies
05

Study design

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

Interventions

  • Drugbortezomib

    PS-341 bolus intravenous injection twice weekly\* for 2 out of every 3 weeks

06

What researchers measure

Primary outcomes

  1. Response rate

    To assess the efficacy (response rate) of PS-341 given as a bolus intravenous injection twice weekly for two out of every 3 weeks in the treatment of a population of patients with previously untreated or relapsed Waldenström's Macroglobulinemia

    Time frame: 4 years

Secondary outcomes

  1. Toxicity

    To assess the toxicity of PS-341 in patients with Waldenström's Macroglobulinemia as well as time to progression, stable disease duration and, if responses are observed, response duration.

    Time frame: 4 years

  2. Cytogenetics and genome profiling

    To assess bone marrow and peripheral blood for cytogenetics and genome profiling by microarray in patients with Waldenstrom's macroglobulinemia.

    Time frame: 4 years

07

Study locations

12 sites
  • Hinsdale Hematology Oncology Associates
    Hinsdale, Illinois 60521, United States
  • Abramson Cancer Center at the University of Pennsylvania
    Philadelphia, Pennsylvania 19104-4283, United States
  • Tom Baker Cancer Centre - Calgary
    Calgary, Alberta T2N 4N2, Canada
  • Cross Cancer Institute
    Edmonton, Alberta T6G 1Z2, Canada
  • CancerCare Manitoba
    Winnipeg, Manitoba R3E 0V9, Canada
  • Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
    Halifax, Nova Scotia B3H 1V7, Canada
  • Margaret and Charles Juravinski Cancer Centre
    Hamilton, Ontario L8V 5C2, Canada
  • Cancer Care Ontario-London Regional Cancer Centre
    London, Ontario N6A 4L6, Canada
  • Toronto Sunnybrook Regional Cancer Centre
    Toronto, Ontario M4N 3M5, Canada
  • Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
  • Maisonneuve-Rosemont Hospital
    Montreal, Quebec H1T 2M4, Canada
  • Saskatoon Cancer Centre
    Saskatoon, Saskatchewan S7N 4H4, Canada
08

References and documents

Publications

  • Chen CI, Kouroukis CT, White D, Voralia M, Stadtmauer E, Stewart AK, Wright JJ, Powers J, Walsh W, Eisenhauer E; National Cancer Institute of Canada Clinical Trials Group. Bortezomib is active in patients with untreated or relapsed Waldenstrom's macroglobulinemia: a phase II study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 Apr 20;25(12):1570-5. doi: 10.1200/JCO.2006.07.8659. Epub 2007 Mar 12. PubMed 17353550 ↗
  • Chen CI, White Darrell, Kouroukis TC, et al.: Antitumor activity of bortezomib (PS-341; Velcade) in a phase II study of patients with previously untreated or treated Waldenstrom's macroglobulinemia (WM). [Abstract] Blood 104 (11): A-3278, 2004.
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00045695
Lead sponsor
NCIC Clinical Trials Group
Collaborators
National Cancer Institute (NCI), Eastern Cooperative Oncology Group
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Aug 2002
Primary completion
Mar 2006
Completion
Dec 2009
Last update
May 17, 2013

Study contacts

Christine I. Chen, MD
study chair · Princess Margaret Hospital, Canada

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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