Multiple Myeloma and Plasma Cell NeoplasmPhase 3NCT00003603
Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma
A Phase 3 study testing cyclophosphamide, dexamethasone and idarubicin in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Riverside Haematology Group at 1 site in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Steroids, such as dexamethasone or prednisolone, may help relieve some of the side effects of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- cyclophosphamide, dexamethasone and idarubicin
- How many people
- 660 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 1998to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma based on at least two of the following:
- Paraprotein in serum and/or urine
- Greater than 10% plasma cells in bone marrow
- Lytic bone lesions
- Measurable serum and/or urine paraprotein
- Progression from first or second stable plateau phase
- No non-secretory myeloma or plasma cell leukemia (greater than 2,000/mm^3 circulating plasma cells)
- No primary refractory disease or second or later relapse
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- 0-3
Life expectancy:
- Not specified
Hematopoietic:
- Neutrophil count at least 1,000/mm^3
- Platelet count at least 75,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- ALT/AST no greater than 2.5 times ULN
Renal:
- Creatinine less than 3.4 mg/dL
Cardiovascular:
- No clinically significant cardiac insufficiency
- No uncontrolled hypertension
Other:
- No uncontrolled diabetes mellitus
- No recent history of peptic ulceration
- HIV-1 and HIV-2 negative
- Fertile patients must use effective contraception during and for 6 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior allogeneic peripheral blood stem cell or bone marrow transplantation
- No planned future autologous transplantation unless sufficient stored stem cells available
- Prior interferon allowed if administered as maintenance of stable plateau phase
- No concurrent epoetin alfa
Chemotherapy:
- At least 3 months since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Concurrent radiotherapy for pain or to treat localized tumors allowed
Surgery:
- Not specified
Other:
- No prior participation in any clinical trial with an unlicensed product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Study Comparing CIDEX (CCNU, Oral Idarubicin and Dexamethasone) With Melphalan and Prednisolone in Relapsed Multiple Myeloma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Steroids, such as dexamethasone or prednisolone, may help relieve some of the side effects of chemotherapy. It is not yet known which regimen of chemotherapy plus steroid therapy is more effective in treating patients with multiple myeloma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy plus steroid therapy in treating patients with multiple myeloma that has recurred for the first time.
Read the detailed description
OBJECTIVES:
- Compare the response rate, response duration, and survival of patients with relapsed multiple myeloma after treatment with lomustine, idarubicin, and dexamethasone vs melphalan and prednisolone.
OUTLINE: This is a randomized study. Patients are stratified according to prior autologous transplant (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral lomustine on day 1, oral idarubicin once daily on days 1-3, and oral dexamethasone twice a day on days 1-4. Treatment is repeated every 28 days for 6-9 courses in the absence of unacceptable toxicity or disease progression.
- Arm II: Patients receive oral melphalan once daily on days 1-4 and oral prednisolone twice a day on days 1-4. Treatment is repeated every 28 days for 6-9 courses in the absence of unacceptable toxicity or disease progression.
Some patients may receive oral cyclophosphamide every 7 days and oral prednisolone on alternate days for 6 weeks concurrently with chemotherapy in either treatment arm.
Quality of life is assessed at baseline, at 3, 6, 9, and 12 months, and then every 6 months thereafter.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study within 5 years.
- Being tested
- cyclophosphamide, dexamethasone, idarubicin, lomustine, melphalan
- Keywords
- refractory multiple myeloma, stage I multiple myeloma, 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.
cyclophosphamideDrug
dexamethasoneDrug
idarubicinDrug
lomustineDrug
melphalanDrug
prednisoloneDrug
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 startMar 1998
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
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riverside Haematology Group
- Sponsor type
- University, hospital or other
- Investigators
- Diana Samson, MD, Study chair, Hammersmith Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003603
- Sponsor's protocol ID
- CDR0000066676
- Other IDs
- RHG-MM97, EU-98030
- Status last verified
- Feb 2001
- First submitted
- 1 Nov 1999
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Study Comparing CIDEX (CCNU, Oral Idarubicin and Dexamethasone) With Melphalan and Prednisolone in Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00003603
- Acronym / sponsor ID
- CDR0000066676
- Keywords
- refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Riverside Haematology GroupUniversity, hospital or other
- Study start
- Mar 1998
- 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 cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Steroids, such as dexamethasone or prednisolone, may help relieve some of the side effects of chemotherapy. It is not yet known which regimen of chemotherapy plus steroid therapy is more effective in treating patients with multiple myeloma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy plus steroid therapy in treating patients with multiple myeloma that has recurred for the first time.
Detailed description
OBJECTIVES:
- Compare the response rate, response duration, and survival of patients with relapsed multiple myeloma after treatment with lomustine, idarubicin, and dexamethasone vs melphalan and prednisolone.
OUTLINE: This is a randomized study. Patients are stratified according to prior autologous transplant (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral lomustine on day 1, oral idarubicin once daily on days 1-3, and oral dexamethasone twice a day on days 1-4. Treatment is repeated every 28 days for 6-9 courses in the absence of unacceptable toxicity or disease progression.
- Arm II: Patients receive oral melphalan once daily on days 1-4 and oral prednisolone twice a day on days 1-4. Treatment is repeated every 28 days for 6-9 courses in the absence of unacceptable toxicity or disease progression.
Some patients may receive oral cyclophosphamide every 7 days and oral prednisolone on alternate days for 6 weeks concurrently with chemotherapy in either treatment arm.
Quality of life is assessed at baseline, at 3, 6, 9, and 12 months, and then every 6 months thereafter.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study within 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| cyclophosphamide | Drug | – |
| dexamethasone | Drug | – |
| idarubicin | Drug | – |
| lomustine | Drug | – |
| melphalan | Drug | – |
| prednisolone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 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.
Diana Samson, MD study chair
Hammersmith Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cyclophosphamide, dexamethasone and idarubicin in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Riverside Haematology Group at 1 site 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: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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.
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 20 Sep 2013.