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 number | NCT00006232 |
| Secondary identifying numbers | H31 |
- 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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Multicentre randomised active controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 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 study start date | 18/10/1996 |
| Completion date | 19/03/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Added as of 04/10/2007: 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 18/10/1996 |
| Date of final enrolment | 19/03/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Pharmacia and Upjohn (UK)
Industry
Industry
-
-
-
United Kingdom
"ROR" |
https://ror.org/04x4v8p40 |
|---|
Funders
Funder type
Industry
Pharmacia and Upjohn (UK)
No information available
Chugai Pharma UK (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
