Higher Frequency Zoledronic Acid in the Treatment of Multiple Myeloma (dtZ)

July 19, 2011 updated by: Gleneagles Hospital

An International, Multicenter, Non-Randomized, Open-Labeled Study to Evaluate the Efficacy of Lower Dose Dexamethasone/Thalidomide and Higher Frequency ZOMETA(TM) in the Treatment of Previously Untreated Patients With Multiple Myeloma

The purpose of this study is to determine whether lower than conventional doses of dexamethasone and thalidomide; and a higher dosing frequency of zoledronic acid are effective in the treatment of newly-diagnosed multiple myeloma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with newly-diagnosed multiple myeloma (MM) may be treated using monthly cycles of dexamethasone plus thalidomide (DT). Unfortunately, the use of conventional doses of DT is associated with significant treatment-related morbidity and mortality, which is comparable to that observed with conventional chemotherapy. Hence, for safety reasons, patients frequently receive lower than conventional doses of DT (i.e. dt), and potentially experience a poorer anti-MM effect. The highly-potent aminobisphosphonate, zoledronic acid (Z), has been shown in pre-clinical mouse models to exhibit an impressive anti-MM effect. It is therefore possible to combined dt with Z (i.e. dtZ) to enhance the efficacy of (lower dose) dt. In addition, the anti-tumor effect of dtZ may potentially be augmented by using Z at a higher (three-weekly) dosing frequency.

Study Type

Interventional

Enrollment (Actual)

56

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

  • India
      • Mumbai, India, 400 012
        • Tata Memorial Hospital
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632004
        • Christian Medical College
  • Korea, Republic of
      • Kwangju, Korea, Republic of, 519-809
        • Chonnam National University Hwasun Hospital
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center, Seoul, South Korea
      • Seoul, Korea, Republic of, 138-736
        • ASAN Medical Center, University of Ulsan, South Korea
  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
      • Singapore, Singapore, 169610
        • National Cancer Centre, Singapore
      • Singapore, Singapore, 258500
        • Gleneagles Hospital, Singapore
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital, Singapore

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age at or above 21 years
  • Clinical diagnosis of MM
  • Active MM with measurable disease
  • Signed written informed consent
  • Signed consent for drug safety program for thalidomide

Exclusion Criteria:

  • Patients with Monoclonal Gammopathy of Undetermined Significance (MGUS)
  • Patients with Indolent MM (IMM), or Smouldering MM (SMM)
  • Known hypersensitivity (including severe cutaneous reactions) to d, t or Z
  • Fulminant sepsis
  • Females in the reproductive age group who refuse contraception
  • Pregnancy
  • 24 hr urinary creatinine clearance time (CCT) <30 ml/min
  • Previous renal transplantation
  • Severe peripheral neuropathy
  • Recurrent DVT or PE
  • Severe arrhythmias and cardiac conduction disorders
  • Liver dysfunction of active viral hepatitis
  • Osteonecrosis of the jaws (ONJ)

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "dtZ" regimen, Initial therapy
To test the efficacy of the "dtZ" regimen in previously untreated patients with multiple myeloma.
Drug: dexamethasone
20 mg, PO (orally) on days 1-4, 8-11 and 15-18 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
Other Names:
  • DEXAMETHASONE BEACONS
Drug: thalidomide
100 mg, PO (orally) on days 1-21 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
Other Names:
  • THALOMID (PHARMION)
  • THADO (TTY)
Drug: zoledronic acid
4 mg, IV (in the vein) on day 1 of each 21 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
Other Names:
  • ZOMETA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1. To determine response rates (RR) and disease progression rates in all MM patients treated with dtZ regimen.
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess overall survival (OS) in all patients treated with dtZ regimen.
Time Frame: 4 months
4 months
Assessment of incidence of skeletal related events (SREs).
Time Frame: 4 months
4 months
Assessment of percent change in renal function in all patients.
Time Frame: 4 months
4 months

Collaborators and Investigators

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

Sponsor

Gleneagles Hospital

Collaborators

Samsung Medical Center
Asan Medical Center
Chonnam National University Hospital
Seoul National University Hospital
Singapore General Hospital
Tan Tock Seng Hospital
Tata Memorial Hospital
National Cancer Centre, Singapore
Christian Medical College, Vellore, India

Investigators

  • Study Chair: Gerrard Teoh, MD, Gleneagles Hospital, Singapore

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

Helpful Links

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

December 1, 2005

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

December 7, 2005

First Submitted That Met QC Criteria

December 7, 2005

First Posted (Estimate)

December 8, 2005

Study Record Updates

Last Update Posted (Estimate)

July 21, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SQMM01(dtZ)

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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