Clinical trial · Interventional
Vorinostat and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma
A Phase I Study of SAHA in Combination With Bortezomib in Relapsed and Refractory Multiple Myeloma
NCT00310024CI-TRIAL-00009357completedPhase 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)
This phase I trial is studying the side effects and best dose of vorinostat when given together with bortezomib in treating patients with relapsed or refractory multiple myeloma. Vorinostat and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with bortezomib may kill more cancer cells
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage III Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage II Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage I Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (vorinostat, bortezomib)
- description
- Patients receive bortezomib IV on days 1, 4, 8, and 11 followed by oral SAHA twice daily on days 4-11. Beginning in course 3, some patients may receive low-dose oral dexamethasone on days 4-8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional cohort of 10 patients receive treatment at the MTD. Patients undergo blood collection and tumor biopsies periodically during study for pharmacologic and biomarker correlative studies.
- interventionNames
- Drug: bortezomib
- Drug: vorinostat
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD) of SAHA in combination with bortezomib determined by dose-limiting toxicities
- timeFrame
- 21 days
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically and clinically confirmed multiple myeloma * Relapsed or refractory disease after prior chemotherapy or transplantation\* * Measurable disease, defined by quantitative immunoglobulin levels in serum and/or urine and bone marrow plasmacytosis * Non-secretory disease allowed provided MRI or positron emission tomography or CT scan can accurately measure at least one plasmacytoma lesion * No known CNS involvement * Life expectancy \> 3 months * ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% * Absolute neutrophil count ≥ 1,000/mm³ (unless myelosuppression is secondary to bone marrow plasmacytosis \[\> 80% involvement\]) * Platelet count ≥ 50,000/mm³ (unless myelosuppression is secondary to bone marrow plasmacytosis \[\> 80% involvement\]) * Bilirubin ≤ 2 times upper limit of normal (ULN) * AST and ALT ≤ 2 times ULN * Creatinine \< 2 mg/dL OR creatinine clearance \> 40 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to swallow pills * Patients with a history of seizures are eligible provided seizures are under adequate control with non-enzyme inducing anticonvulsant medication * No history of allergic reactions attributed to study agents * No sensory or motor neuropathy ≥ grade II * No uncontrolled current illness including, but not limited to, the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situation that would limit study compliance * No grade 3 QT prolongation (i.e., \> 500 msec) at baseline * See Disease Characteristics * Prior bortezomib allowed * At least 2 weeks since prior therapy for multiple myeloma * Concurrent growth factors (filgrastim \[G-CSF\] and epoetin alfa) to sustain peripheral blood counts (during the first course of therapy only) allowed * Concurrent steroid therapy (≤ 20 mg of prednisone) for patients requiring chronic use for disorders other than myeloma allowed * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational or commercial agents or therapies for this malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.