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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00389701
First received: October 18, 2006
Last updated: June 16, 2009
Last verified: June 2009
History of Changes
  Purpose

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 Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
 Drug: bortezomib
Drug: dexamethasone
 Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Tolerability [ Designated as safety issue: Yes ]
  • Duration of response after completion of treatment [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Overall and progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2006
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389701

Locations
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
Study Chair: Gordan Srkalovic, MD, PhD Sparrow Regional Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Gordan Srkalovic, Sparrow Regional Cancer Center
ClinicalTrials.gov Identifier: NCT00389701     History of Changes
Other Study ID Numbers: CDR0000509044, SPARROW-I071-341-03, SPARROW-IRB-6016
Study First Received: October 18, 2006
Last Updated: June 16, 2009
Health Authority: Unspecified

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:
Plasmacytoma
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
 Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bortezomib
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on June 17, 2013