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A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Waldenstrom's Macroglobulinemia

Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Waldenstrom's Macroglobulinemia


- 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

Inclusion Criteria


- Diagnosis of Waldenstrom's macroglobulinemia confirmed by immunofixation or

- 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



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks


- See Disease Characteristics

- Absolute granulocyte count ≥ 1,000/mm^3

- Platelet count ≥ 50,000/mm^3


- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST or ALT ≤ 2.5 times ULN


- Creatinine ≤ 1.5 times ULN


- 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


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


- 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


- 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


- At least 4 weeks since prior major surgery


- At least 4 weeks since prior plasmapheresis

- At least 4 weeks since prior investigational anticancer therapy

- No other concurrent investigational anticancer agents or therapies

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

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

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Christine I. Chen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada


United States: Federal Government

Study ID:




Start Date:

August 2002

Completion Date:

December 2009

Related Keywords:

  • Lymphoma
  • Waldenstrom macroglobulinemia
  • Lymphoma
  • Waldenstrom Macroglobulinemia



Hinsdale Hematology Oncology Associates Hinsdale, Illinois  60521
Abramson Cancer Center at the University of Pennsylvania Philadelphia, Pennsylvania  19104