Clinical trial · Interventional
Bortezomib in Treating Patients With Advanced Myeloproliferative Disorders
A Prospective Open-Label Pilot Trial of PS-341 (Bortezomib; VELCADE) for the Therapy of Symptomatic Advanced Myeloproliferative Disorders
NCT00437086CI-TRIAL-00015855completedEarly Phase 1ClinicalTrials.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 abnormal cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the abnormal cells. PURPOSE: This clinical trial is studying the side effects and how well bortezomib works in treating patients with advanced myeloproliferative disorders.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PS-341 | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PS-341
- description
- Designed to assess the toxicity and pilot response of PS-341 in patients with advanced myeloproliferative diseases.
- interventionNames
- Drug: PS-341
Primary outcomes (2)
- measure
- Number and severity of toxicities as assessed by NCI CTCAE v3.0
- timeFrame
- 40 weeks
- measure
- Proportion of patients who show treatment success, as defined by anemia, spleen, bone marrow, or constitutional symptoms' response (complete, partial, major, or minor response)
- timeFrame
- 40 weeks
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed advanced myeloproliferative disorder, including 1 of the following subtypes:
* Myelofibrosis with myeloid metaplasia defined by the following criteria:
* Evaluable or symptomatic disease as evidenced by ≥ 1 of the following:
* Anemia, defined as hemoglobin \< 10 g/dL OR erythrocyte-transfusion dependence, defined as requiring 1 transfusion within the past 8 weeks
* Symptomatic palpable splenomegaly (palpable hepatomegaly is acceptable if previously splenectomized) requiring treatment\* NOTE: \*Subjective but painful enough to mandate intervention
* Chronic myelomonocytic leukemia (CMML) defined by the following criteria:
* Absence of an imatinib mesylate-sensitive molecular abnormality for CMML (i.e., t\[5;12\], t\[5;10\], t\[1;5\], and t\[5;7\]) confirmed by fluorescent in situ hybridization (FISH) or standard cytogenetic bone marrow analysis within the past 18 months
* Symptomatic disease as evidenced by ≥ 1 of the following:
* Anemia, defined as hemoglobin \< 10 g/dL OR erythrocyte-transfusion dependence, defined as requiring 1 transfusion within the past 8 weeks
* Palpable splenomegaly (palpable hepatomegaly is acceptable if previously splenectomized) requiring treatment\* NOTE: \*Subjective but painful enough to mandate intervention
* Leukocytosis associated with ascites, serositis, pleural effusions, vasculitis, or other overt manifestation
* Systemic mast cell disease defined by the following criteria:
* Absence of the FIP1LI-PDGFRA mutation as confirmed by FISH
* Evaluable and symptomatic disease requiring therapy, as evidenced by involvement with organs other than skin (i.e., heart, bowel, peripheral blood, liver/spleen, or marrow)
* Debilitating mast cell mediator symptoms not responsive to standard therapy such as antihistamines
* Absence of t(9;22) translocation as confirmed by FISH or standard cytogenetic peripheral blood or marrow analysis at any prior time point
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Not incarcerated in a municipal, county, state, or federal prison
* Absolute neutrophil count ≥ 1,000/mm³
* Platelet count ≥ 75,000/mm³
* Creatinine ≤ 2.0 mg/dL
* Total or direct bilirubin ≤ 2.0 mg/dL
* AST and ALT ≤ 3 times upper limit of normal (unless clinically attributed to hepatic extramedullary hematopoiesis)
* No baseline peripheral or autonomic neuropathy ≥ grade 2
* No other condition or laboratory abnormality that would place the patient at unacceptable risk or confound the ability to interpret study data
* No hypersensitivity to boron, mannitol, or bortezomib
* No myocardial infarction within the past 6 months
* No New York Hospital Association class III-IV heart failure
* No uncontrolled angina
* No severe uncontrolled ventricular arrhythmia
* No evidence of acute ischemia or active conduction system abnormality by ECG
* ECG screening abnormalities must be documented as not medically relevant
* No other serious medical or psychiatric illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
* At least 14 days since prior chemotherapy (e.g., interferon alfa, anagrelide, or other myelosuppressive agent) or any other experimental therapy
* At least 14 days since prior growth factors
* At least 14 days since prior systemic use of corticosteroids
* More than 14 days since prior investigational drugs
* Concurrent hydroxyurea allowed for ≤ 14 days during study therapy if clinically indicated for extreme leukocytosis controlReferences
Publications (0)
Data not yet available
No reference posted for this study.