NCT00389701

Brief Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with dexamethasone may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with dexamethasone works in treating patients with multiple myeloma that has relapsed or has not responded to treatment.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

January 10, 2014

Status Verified

June 1, 2009

Enrollment Period

3.8 years

First QC Date

October 18, 2006

Last Update Submit

January 9, 2014

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

Secondary Outcomes (5)

  • Toxicity

  • Tolerability

  • Duration of response after completion of treatment

  • Time to progression

  • Overall and progression-free survival

Interventions

bortezomibDRUG
dexamethasoneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma * Refractory or relapsed disease meeting the following criteria: * Primary refractory disease and first-line relapsing disease * Progressive disease after last therapy PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 3 months * Platelet count ≥ 50,000/mm³ (≥ 30,000/mm³ for patients with significant bone marrow involvement) * Transfusions allowed * Hemoglobin ≥ 7.5 g/dL * Absolute neutrophil count ≥ 750/mm³ * Serum calcium \< 14 mg/dL * AST and ALT \< 2.5 times upper limit of normal * Creatinine clearance ≥ 30 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No peripheral neuropathy ≥ grade 2 within the past 14 days * No hypersensitivity to boron or mannitol * No cardiovascular complications, including any of the following: * Myocardial infarction within the past 6 months * New York Heart Association class III-IV heart failure * Uncontrolled angina * Ventricular arrhythmias * Electrocardiographic evidence of acute ischemia or active conduction system abnormalities * Cardiac amyloidosis * No other cancer or treatment for cancer other than basal cell cancer of the skin within the past 5 years * No poorly controlled chronic diseases (e.g., diabetes mellitus or hypertension) * No HIV positivity * No hepatitis B surface antigen or active hepatitis C infection * No active systemic infection requiring therapy * No serious medical or psychiatric illness that would interfere with study participation PRIOR CONCURRENT THERAPY: * No plasmapheresis within the past 4 weeks * No major surgery within the past 4 weeks * No prior bortezomib * No chemotherapy (e.g., clarithromycin) within the past 4 weeks * No radiotherapy within the past 3 weeks * No corticosteroids (\> 10 mg/day of prednisone or equivalent) within the past 3 weeks * No other immunotherapy within the past 8 weeks * No other investigational drugs within the past 14 days * No concurrent participation in other clinical research studies

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sparrow Regional Cancer Center

Lansing, Michigan, 48909-7980, United States

RECRUITING

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

BortezomibDexamethasone

Condition Hierarchy (Ancestors)

Neoplasms 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 CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Gordan Srkalovic, MD, PhD

    Sparrow Regional Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2006

First Posted

October 19, 2006

Study Start

March 1, 2006

Primary Completion

December 1, 2009

Last Updated

January 10, 2014

Record last verified: 2009-06

Locations

US(1)