NCT00310024

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

2.3 years

First QC Date

March 29, 2006

Last Update Submit

February 6, 2013

Conditions

Refractory Multiple MyelomaStage I Multiple MyelomaStage II Multiple MyelomaStage III Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose (MTD) of SAHA in combination with bortezomib determined by dose-limiting toxicities

    21 days

Secondary Outcomes (3)

  • Inhibition of histone deacetylation

    Up to 1 month

  • Response

    Up to 1 month

  • Survival (disease specific and overall)

    Up to 1 month

Study Arms (1)

Treatment (vorinostat, bortezomib)

EXPERIMENTAL

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.

Drug: bortezomibDrug: vorinostatOther: laboratory biomarker analysisOther: pharmacological study

Interventions

bortezomibDRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE
Treatment (vorinostat, bortezomib)
vorinostatDRUG

Given orally

Also known as: L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza
Treatment (vorinostat, bortezomib)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (vorinostat, bortezomib)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (vorinostat, bortezomib)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201-1595, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

BortezomibVorinostat

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesAniline CompoundsAminesHydroxamic AcidsHydroxylaminesHydroxy AcidsCarboxylic Acids

Study Officials

  • Ashraf Badros

    University of Maryland Greenebaum Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2006

First Posted

April 3, 2006

Study Start

November 1, 2005

Primary Completion

February 1, 2008

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

US(1)