Clinical trial · Interventional
Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia
A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Waldenstrom's Macroglobulinemia
NCT00045695CI-TRIAL-00010344completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 4 years
- 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
Secondary outcomes (2)
- measure
- Toxicity
- timeFrame
- 4 years
- description
- 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.
- measure
- Cytogenetics and genome profiling
- timeFrame
- 4 years
- description
- To assess bone marrow and peripheral blood for cytogenetics and genome profiling by microarray in patients with Waldenstrom's macroglobulinemia.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTChen 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. PMID 17353550
- RESULTChen 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.