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Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00389701

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

A Phase 2 study testing bortezomib and dexamethasone in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Sparrow Regional Cancer Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bortezomib and dexamethasone
How many people
30 participants
Where
1 siteUnited States
Study dates
Mar 2006to Dec 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48909-7980

    Gordan Srkalovic, MD, PhD, 517-364-2467, gordan.srkalovic@sparrow.org

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

Secondary outcomes (5)

  1. Toxicity

  2. Tolerability

  3. Duration of response after completion of treatment

  4. Time to progression

  5. Overall and progression-free survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionDec 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00389701
Sponsor's protocol ID
CDR0000509044
Other IDs
SPARROW-I071-341-03, SPARROW-IRB-6016
Status last verified
Jun 2009
First submitted
18 Oct 2006
Last updated
10 Jan 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bortezomib and dexamethasone in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Sparrow Regional Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00389701.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014.

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