Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
07/06/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00006232

Protocol/serial number

H31

Study information

Scientific title

Acronym

Study hypothesis

Added 07/08/09:
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.The aim of this trial is to compare two combination chemotherapy regimens, Zevedos® and dexamethasone (Z-DEX) and vincristine, adriamycin and dexamehasone (VAD) to see how well they work in treating patients with stage II or stage III multiple myeloma.

As of 07/08/09 this record has been extensively updated. All updates can be found under the relevant field with the above update date.

Ethics approval

Not provided at time of registration.

Study design

Multicentre randomised active controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Plasma cell neoplasms

Intervention

Z-DEX Regimen: Zovedos capsules Days 1-4. Dexamethasone Days 1-4 (Cycle 1 only: days 8-11). Cycle repeated every 21 days for a max of six cycles.

VAD Regimen: Adriamycin Days 1-4. Vincristine Days 1-4. Dexamethasone Days 1-4 (Cycle 1 only: Days 8-11). Every 21 days for a max of six cycles.

Intervention type

Drug

Phase

Phase III

Drug names

Idarubicin (Zovedos®), dexamethasone, vincristine, doxorubicin (Adriamycin®)

Primary outcome measures

Added 07/08/09:
Response rate

Secondary outcome measures

Added 07/08/09:
1. Time to maximum response
2. Duration of response

Overall trial start date

18/10/1996

Overall trial end date

19/03/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Current information as of 07/08/09:
1. Diagnosis of multiple myeloma as in current MRC UK guidelines
2. Durie-Salmon stage II and III disease
3. <75 years of age
4. Bilirubin ≤ 2.34mg/dL
5. Adequate contraceptive measures

Initial information at time of registration:
1. Diagnosis of multiple myeloma as in current MRC UK guidelines
2. Durie-Salmon stage II and III disease

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Added as of 04/10/2007: 200

Participant exclusion criteria

Current information as of 07/08/09:
1. Previous or concurrent therapy (except radiotherapy for bone lesions)
2. End stage renal failure (creatinine greater than 5.65 mg/dL after rehydration)
3. Requires dialysis
4. Pregnant or nursing
5. Prior malignancy
6. Other medical condition that would preclude intensive treatment

Initial information at time of registration:
Previous treatment other than local radiotherapy to bone lesions

Recruitment start date

18/10/1996

Recruitment end date

19/03/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Pharmacia and Upjohn (UK)

Sponsor details

-
-
-
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Pharmacia and Upjohn (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Chugai Pharma UK (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15352982

Publication citations

  1. Results

    Cook G, Clark RE, Morris TC, Robertson M, Lucie NP, Anderson S, Paul J, Franklin IM, A randomized study (WOS MM1) comparing the oral regime Z-Dex (idarubicin and dexamethasone) with vincristine, adriamycin and dexamethasone as induction therapy for newly diagnosed patients with multiple myeloma., Br. J. Haematol., 2004, 126, 6, 792-798, doi: 10.1111/j.1365-2141.2004.05127.x.

Additional files

Editorial Notes