Multiple Myeloma and Plasma Cell NeoplasmPhase 3NCT00006232
Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma
A Phase 3 study testing dexamethasone, doxorubicin hydrochloride and idarubicin in people with Multiple Myeloma and Plasma Cell Neoplasm, run by West of Scotland Lymphoma Group at 12 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- dexamethasone, doxorubicin hydrochloride and idarubicin
- How many people
- 200 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- Oct 1996to Aug 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United Kingdom12 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Vale Of Leven D G Hospital
Alexandria, Scotland, G83 0UA
Centre for Cancer Research and Cell Biology at Belfast City Hospital
Belfast, Northern Ireland, BT9 7AB
Birmingham Heartlands Hospital
Birmingham, England, B9 5SS
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, CB2 2QQ
Dumfries Royal Infirmary
Dumfries, Scotland, DG1 4AP
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
West of Scotland Cancer Centre
Glasgow, Scotland, G11 6NT
Royal Infirmary - Castle
Glasgow, Scotland, G4 0SF
Royal Liverpool and Broadgreen Hospitals NHS Trust
Liverpool, England, L7 8XP
Royal Alexandra Hospital
Paisley, Scotland
New Cross Hospital
Wolverhampton, England, WV10 0QP
About this study
Official title: 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.
Read the 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.
- Being tested
- dexamethasone, doxorubicin hydrochloride, idarubicin, vincristine sulfate
- Keywords
- stage II multiple myeloma, stage III multiple myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of response rates
Secondary outcomes (2)
Time to achieve a maximal response
Duration of response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 1996
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West of Scotland Lymphoma Group
- Sponsor type
- University, hospital or other
- Investigators
- Gordon Cook, MD, PhD, Study chair, Leeds Cancer Centre at St. James's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006232
- Sponsor's protocol ID
- WSLG-H31
- Other IDs
- CDR0000068156, EU-20032, ISRCTN65684689
- Status last verified
- Mar 2007
- First submitted
- 11 Sep 2000
- Last updated
- 15 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00006232
- Acronym / sponsor ID
- WSLG-H31
- Keywords
- stage II multiple myeloma, stage III multiple myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- West of Scotland Lymphoma GroupUniversity, hospital or other
- Study start
- Oct 1996
- Study completion
- Aug 2007 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasone | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| idarubicin | Drug | – |
| vincristine sulfate | Drug | – |
Primary outcome
Comparison of response rates
2 secondary outcomes
Time to achieve a maximal response
Duration of response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon Cook, MD, PhD study chair
Leeds Cancer Centre at St. James's University Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dexamethasone, doxorubicin hydrochloride and idarubicin in people with Multiple Myeloma and Plasma Cell Neoplasm, run by West of Scotland Lymphoma Group at 12 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of response rates. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2013.