Recruiting
Phase 2

Bortezomib & Dexamethasone

Sponsor:

Sparrow Regional Cancer Center

Code:

NCT00389701

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

bortezomib

dexamethasone

Study Details

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Study ID

NCT00389701

Start date

Mar, 2006

Status verified date

Jun, 2009

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

bortezomib

dexamethasone

Primary outcome measure

  • Overall response rate [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Sparrow Regional Cancer Center

Recruiting

Lansing, Michigan, United States, 48909-7980

Contacts

Gordan Srkalovic, MD, PhD

517-364-2467gordan.srkalovic@sparrow.org

More Information

Sponsor

Sparrow Regional Cancer Center

Last update posted

Jan 10, 2014

Last verified

Jun, 2009

Keywords

  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • refractory multiple myeloma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sparrow Regional Cancer Center on 2014-01-10.