Bortezomib and Dexamethasone in Treating Patients With Multiple Myeloma That Has Relapsed or Has Not Responded to Treatment

January 9, 2014 updated by: Sparrow Regional Cancer Center

Phase II Trial of Twice Weekly Induction Followed by Once Weekly IV Velcade (Bortezomib) With Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Following at Least 1 Prior Therapy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the overall response rate (complete response and partial response) in patients with relapsed or refractory multiple myeloma treated with induction therapy and maintenance therapy comprising bortezomib and dexamethasone.

Secondary

  • Determine the toxicity of this regimen in these patients
  • Determine the tolerability of this regimen in these patients.
  • Determine the duration of response in patients treated with this regimen.
  • Determine time to progression in patients treated with this regimen.
  • Determine overall and progression-free survival of patients treated with this regimen.

OUTLINE: This is an open-label study.

  • Induction therapy: Patients receive bortezomib IV on days 1, 4, 8, and 11. Patients also receive oral dexamethasone on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 4 courses. Patients who achieve complete response (CR) receive an additional 2 courses of induction therapy and proceed to maintenance therapy.
  • Maintenance therapy: Patients receive bortezomib IV on days 1, 8, 15, and 22. Patients also receive oral dexamethasone on days 1, 2, 8, 9, 15, 16, 22, and 23. Treatment repeats every 36 days in the absence of disease progression or unacceptable toxicity. Patients who achieve CR receive an additional 2 courses of maintenance therapy beyond documentation of CR.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Lansing, Michigan, United States, 48909-7980
        • Recruiting
        • Sparrow Regional Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall response rate

Secondary Outcome Measures

Outcome Measure
Toxicity
Time to progression
Tolerability
Overall and progression-free survival
Duration of response after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sparrow Regional Cancer Center

Investigators

  • Study Chair: Gordan Srkalovic, MD, PhD, Sparrow Regional Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

October 18, 2006

First Submitted That Met QC Criteria

October 18, 2006

First Posted (Estimate)

October 19, 2006

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000509044
  • SPARROW-I071-341-03
  • SPARROW-IRB-6016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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