Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma

May 14, 2013 updated by: West of Scotland Lymphoma Group

A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for multiple myeloma.

PURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III multiple myeloma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the partial and complete response rates in patients with multiple myeloma treated with induction therapy comprising idarubicin and dexamethasone vs vincristine, doxorubicin, and dexamethasone.
  • Compare the disease progression, time to achieve maximal response, and duration of response in patients treated with these 2 regimens.
  • Compare the quality of life of patients treated with these 2 regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral idarubicin and oral dexamethasone daily on days 1-4. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone daily on days 8-11 during course 1 only.
  • Arm II: Patients receive oral dexamethasone daily, doxorubicin IV continuously, and vincristine IV continuously on days 1-4. Courses repeat as in arm I. Patients receive additional dexamethasone as in arm I.

Patients without a maximal response after completion of course 4 may receive up to 2 additional courses.

Quality of life is assessed at baseline and then prior to each study course.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study within 2 years.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

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

  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
      • Liverpool, England, United Kingdom, L7 8XP
        • Royal Liverpool and Broadgreen Hospitals NHS Trust
      • Wolverhampton, England, United Kingdom, WV10 0QP
        • New Cross Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT9 7AB
        • Centre for Cancer Research and Cell Biology at Belfast City Hospital
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Alexandria, Scotland, United Kingdom, G83 0UA
        • Vale Of Leven D G Hospital
      • Dumfries, Scotland, United Kingdom, DG1 4AP
        • Dumfries Royal Infirmary
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School
      • Glasgow, Scotland, United Kingdom, G4 0SF
        • Royal Infirmary - Castle
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • West of Scotland Cancer Centre
      • Paisley, Scotland, United Kingdom
        • Royal Alexandra Hospital

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

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of stage II or III multiple myeloma

    • No prior therapy except local radiotherapy to bone lesions
  • No indolent multiple myeloma
  • No monoclonal gammopathy of unknown significance

PATIENT CHARACTERISTICS:

Age:

  • 75 and under

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 2.34 mg/dL

Renal:

  • No end stage renal failure (creatinine greater than 5.65 mg/dL after rehydration)
  • No requirement for dialysis

Other:

  • No other medical condition that would preclude intensive treatment
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other prior malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • Concurrent local radiotherapy allowed for painful lesions or lesions that appear likely to lead to an imminent fracture

Surgery

  • See Disease Characteristics

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: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Comparison of response rates

Secondary Outcome Measures

Outcome Measure
Duration of response
Time to achieve a maximal response

Collaborators and Investigators

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

Sponsor

West of Scotland Lymphoma Group

Investigators

  • Study Chair: Gordon Cook, MD, PhD, Leeds Cancer Centre at St. James's University Hospital

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

October 1, 1996

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WSLG-H31
  • CDR0000068156 (Registry Identifier: PDQ (Physician Data Query))
  • EU-20032
  • ISRCTN65684689

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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