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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15352982
Publication citations
-
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.