A randomised trial comparing Z-DEX with VAD as induction therapy for patients with multiple myeloma

ISRCTN ISRCTN65684689
DOI https://doi.org/10.1186/ISRCTN65684689
ClinicalTrials.gov (NCT) NCT00006232
Protocol serial number H31
Sponsor Pharmacia and Upjohn (UK)
Funders Pharmacia and Upjohn (UK), Chugai Pharma UK (UK)
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
07/06/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr - -
Scientific

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

Study information

Primary study designInterventional
Study designMulticentre randomised active controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific title
Study objectivesAdded 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(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedPlasma cell neoplasms
InterventionZ-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 typeDrug
PhasePhase III
Drug / device / biological / vaccine name(s)Idarubicin (Zovedos®), dexamethasone, vincristine, doxorubicin (Adriamycin®)
Primary outcome measure(s)

Added 07/08/09:
Response rate

Key secondary outcome measure(s)

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

Completion date19/03/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration200
Key inclusion criteriaCurrent 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
Key exclusion criteriaCurrent 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
Date of first enrolment18/10/1996
Date of final enrolment19/03/2002

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2004 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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