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

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ClinicalTrials.gov Identifier: NCT00389701
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : October 19, 2006
Last Update Posted : January 10, 2014
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Drug: bortezomib Drug: dexamethasone Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2006
Estimated Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate

Secondary Outcome Measures :
  1. Toxicity
  2. Tolerability
  3. Duration of response after completion of treatment
  4. Time to progression
  5. Overall and progression-free survival

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389701


Locations
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United States, Michigan
Sparrow Regional Cancer Center Recruiting
Lansing, Michigan, United States, 48909-7980
Contact: Gordan Srkalovic, MD, PhD    517-364-2467    gordan.srkalovic@sparrow.org   
Sponsors and Collaborators
Sparrow Regional Cancer Center
Investigators
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Study Chair: Gordan Srkalovic, MD, PhD Sparrow Regional Cancer Center
More Information
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Responsible Party: Gordan Srkalovic, Sparrow Regional Cancer Center
ClinicalTrials.gov Identifier: NCT00389701    
Other Study ID Numbers: CDR0000509044
SPARROW-I071-341-03
SPARROW-IRB-6016
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: June 2009
Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
 Immune System Diseases
Dexamethasone
Bortezomib
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents