Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse

January 7, 2013 updated by: Peter MacCallum Cancer Centre, Australia

Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse An Australian Myeloma Forum Multi-Centre Phase II Trial

This study has two main aims. The first is to assess whether Dexamethasone can increase the number of patients with who respond to Velcade.

The second aim of this study is to see whether treating patients with relapsed multiple myeloma with Velcade and Dexamethasone for a longer period of time extends the time that the myeloma is under control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Velcade is a new drug, which is being developed for the treatment of patients with a variety of cancers. In studies to date, it has been shown to be useful in the treatment of patients with advanced multiple myeloma whose myeloma has progressed after standard drug treatment. Approximately one third of them have had a response to treatment, which has lasted for approximately 12 months. It has been associated with improvement in symptoms from the disease including improvements in blood counts, fewer blood transfusions and in a lessening of bone pain. There is some evidence that more patients respond to Velcade when it is given together with a steroid drug, Dexamethasone, which is commonly used in the treatment of Myeloma, and you may have received in the past. Only a small number of patients have been treated with Velcade and Dexamethasone from the beginning of therapy. However, many more have had Dexamethasone added later if they have failed to respond to Velcade on its own.

Velcade is approved in the USA and Europe by the Food and Drug Administration (FDA) for the treatment of patients with myeloma. However, Velcade is not approved in Australia and therefore its use in this study is considered experimental.

This study has two main aims. The first is to assess whether Dexamethasone can increase the number of patients who respond to Velcade in the controlled setting of a clinical trial. This study is specifically designed for patients who have received at least one kind of standard treatment in the past and are now in need of further therapy because their disease has relapsed. The second aim of this study is to see whether treating patients with Velcade and Dexamethasone for a longer period of time extends the time that the myeloma is under control. This is known as maintenance treatment.

Approximately 100 patients will participate around Australia.

Study Type

Interventional

Enrollment (Actual)

101

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

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 8006
        • Peter MacCallum Cancer Centre

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient was previously diagnosed with multiple myeloma based on standard criteria and currently requires second or *third line therapy because of PD, defined as a 25% increase in M-protein, or development of new or worsening of existing lytic bone lesions or soft tissue plasmacytomas, or hypercalcemia (serum calcium >11.5 mg/dL), or relapse from CR.*Patients will only be eligible for bortezomib as 3rd line therapy if they have received dexamethasone alone, thalidomide alone (or with corticosteroids) or revlimid alone (or with corticosteroids) as one of the 2 prior therapies.
  • Patient is of a legally consenting age, as defined by local regulations.
  • Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
  • Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
  • Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
  • Male patient agrees to use an acceptable method for contraception for the duration of the study.
  • Patient has measurable disease
  • Patient has a Karnofsky performance status ≥60%.
  • Patient has a life-expectancy >3 months.

Exclusion Criteria:

  • Primary Dexamethasone resistance
  • Prior therapy with Bortezomib
  • Prior severe allergic reactions to Bortezomib (Velcade), Boron or Mannitol
  • Neuropathy > Grade 2 with pain by NCI-CTCAE criteria

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
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bortezomib and Dexamethasone
Drug: Bortezomib
Induction- 1.3mg/m2 IV days 1,4,8,11 every 3 weeks up to 8 cycles Consolidation- 1.3mg/m2 IV days 1,8,15,22 every 5 weeks up to 3 cycles Maintenance- 1.3mg/m2 IV days 1,15 every 4 weeks
Drug: Dexamethasone
Induction- 20mg orally days 1,2,4,5,8,9,11,12 every 3 weeks up to 8 cycles Consolidation- 20mg orally days 1,2,8,9,15,16,22,23 every 5 weeks up to 3 cycles Maintenance- 20mg orally days 1,2,15,16 every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Response Rate, defined as the best response on treatment assessed using the EBMT criteria
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time To Progression, defined as the time from commencement of treatment to the date of first evidence of progressive disease.
Time Frame: 2 years
2 years
Overall survival, defined as the time from commencement of treatment to the date of death from any cause.
Time Frame: 2years
2years

Collaborators and Investigators

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

Sponsor

Peter MacCallum Cancer Centre, Australia

Collaborators

Janssen-Cilag Ltd.

Investigators

  • Principal Investigator: Miles Prince, MD, Peter MacCallum Cancer Centre, Melbourne, Australia.
  • Principal Investigator: Simon Harrison, MB, BS., PhD, Peter MacCallum Cancer Centre, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2006

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

June 7, 2006

First Submitted That Met QC Criteria

June 7, 2006

First Posted (Estimate)

June 9, 2006

Study Record Updates

Last Update Posted (Estimate)

January 9, 2013

Last Update Submitted That Met QC Criteria

January 7, 2013

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05/69
  • ACTRN (pending)

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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