Multiple MyelomaPhase 3NCT00205764
Tandem High Dose Melphalan Versus Triple Intermediate Dose Melphalan and Stem Cell Transplantation in Induction Phase and Prednisolone/IFN Versus IFN in Maintenance Therapy
A Phase 3 study testing Melphalan in people with Multiple Myeloma, run by Austrian Forum Against Cancer at 1 site in Austria.
Trial summary
This is an international,multicenter, prospective, open, double randomised and controlled phase III study to compare the therapeutic efficacy of tandem high dose Melphalan versus triple intermediate dose Melpahaln in newly-diagnosed myeloma patients Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Melphalan
- How many people
- 212 participants
- Where
- 1 siteAustria
- Study dates
- Mar 1999to Oct 2009
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly diagnosed multiple myeloma of either IgG, IgG, IgD, IgE, IgM (but excluding Waldenstöm´s macroglobulinemia) lambda of kappa light chain, low-secretory, non-secretory disease or plasma cell leukemia
- Performance status of 0, 1, 2, or 3
- Patients not pre-treated with cytostatic drugs
- Patients who clearly require treatment (usually Durie and Salmon stage II or III)
- Patients in stage I who are symptomatic and/or show progression of their disease
- Patients must have an anticipated life expectancy of at least 3 months
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- Patients must have adequate organ function
- Patients must have had a minimum recovery period of 2 weeks following any major surgical procedure before entry into this study
- Patients must be between 19 and 70 years of age, also it is understood that most of the patients above 65 will not be eligible because of poor performance status or multimorbidity
- Women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment
- Patients must have signed an informed consent
Who cannot join
- Patients with more than 3 irradiation fields
- Patients presenting initially with one of the following conditions:
- Extramedullary plasmacytoma or solitary plasmacytoma
- Monoclonal gammopathy of undetermined significance
- Smouldering myeloma
- Patients with an irreversible performance status of 4
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- Medical of psychiatric conditions that compromise the patient´s ability to give informed consent or complete the study
- Patients with congestive heart failure, NYHA III, IV
- Known HIV positivity
- Known intolerance to any of the study drugs or components
- Acute infection requiring systemic antibiotics at study entry until fully resolved
- Patients with any underlying medical condition which cannot be adequately controlled
- Patients with second primary malignancies (with the exception of cervical carcinoma in situ and non-melanoma skin malignancies) are not eligible unless the patient has been disease-free for at least five years
Trial locations and contacts
1 site in 1 country.
Austria1 site
Wilhelminenspital, 1st Medical Department-center for oncology and hematology
Vienna, 1160
About this study
Official title: Randomised, Non-blind, Parallel Group Study to Compare Tandem High Dose Melphalan (200mg/m²) Versus Triple Intermediate Dose Melphalan (100mg/m²) and Stem Cell Transplantation in Induction Phase and Prednisolone/IFN Versus IFN in Maintenance Therapy in Newly Diagnosed Patients With Multiple Myeloma
This is an international,multicenter, prospective, open, double randomised and controlled phase III study to compare the therapeutic efficacy of tandem high dose Melphalan versus triple intermediate dose Melpahaln in newly-diagnosed myeloma patients
Read the detailed description
Patients will be enrolled into this protocol before start of Induction therapy which consists of 3 cycles or VAD with a 4 week interval followed by 1 cycle of IEV after which stem cell harvesting is performed. After stem cell harvesting is completed Patients will be randomised to one of the high dose therapy arms after response evaluation (Complete remission, Partial remission or stable disease). One group is receiving 2 Cycles of Melphalan 200mg/m² each followed by stem cell transplantation, the other group is receiving 3 Cycles of Melphalan 100mg/m² also followed by stem cell transplantation each time.
After completing high dose therapy patients will be randomised into Maintenance responding with CR, PR or SD. The maintenance therapy will be continued until relapse or progression of disease as defined by the response criteria.
- Conditions
- Multiple Myeloma
- Being tested
- Melphalan
- Keywords
- Multiple Myeloma, first line tretment, high dose chemotherapy, stem cell transplantation, maintenance therapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelphalanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure
Secondary outcomes (5)
Response rate
Time to response
Tolerance of treatment
Quality of life
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 1999
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Austrian Forum Against Cancer
- Sponsor type
- University, hospital or other
- Investigators
- Heinz Ludwig, MD,Univ.Prof, Principal investigator, Wilhelminenspital 1st medical dep.-center for oncology and hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205764
- Sponsor's protocol ID
- 03/99
- Status last verified
- Nov 2013
- First submitted
- 12 Sep 2005
- Last updated
- 25 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Non-blind, Parallel Group Study to Compare Tandem High Dose Melphalan (200mg/m²) Versus Triple Intermediate Dose Melphalan (100mg/m²) and Stem Cell Transplantation in Induction Phase and Prednisolone/IFN Versus IFN in Maintenance Therapy in Newly Diagnosed Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00205764
- Acronym / sponsor ID
- 03/99
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, first line tretment, high dose chemotherapy, stem cell transplantation, maintenance therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Austrian Forum Against CancerUniversity, hospital or other
- Study start
- Mar 1999
- Study completion
- Oct 2009 (actual)
- First posted
- 20 Sep 2005 (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.
This is an international,multicenter, prospective, open, double randomised and controlled phase III study to compare the therapeutic efficacy of tandem high dose Melphalan versus triple intermediate dose Melpahaln in newly-diagnosed myeloma patients
Detailed description
Patients will be enrolled into this protocol before start of Induction therapy which consists of 3 cycles or VAD with a 4 week interval followed by 1 cycle of IEV after which stem cell harvesting is performed. After stem cell harvesting is completed Patients will be randomised to one of the high dose therapy arms after response evaluation (Complete remission, Partial remission or stable disease). One group is receiving 2 Cycles of Melphalan 200mg/m² each followed by stem cell transplantation, the other group is receiving 3 Cycles of Melphalan 100mg/m² also followed by stem cell transplantation each time.
After completing high dose therapy patients will be randomised into Maintenance responding with CR, PR or SD. The maintenance therapy will be continued until relapse or progression of disease as defined by the response criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with newly diagnosed multiple myeloma of either IgG, IgG, IgD, IgE, IgM (but excluding Waldenstöm´s macroglobulinemia) lambda of kappa light chain, low-secretory, non-secretory disease or plasma cell leukemia
- Performance status of 0, 1, 2, or 3
- Patients not pre-treated with cytostatic drugs
- Patients who clearly require treatment (usually Durie and Salmon stage II or III)
- Patients in stage I who are symptomatic and/or show progression of their disease
Key exclusion criteria (13 listed)
- Patients with more than 3 irradiation fields
- Patients presenting initially with one of the following conditions:
- Extramedullary plasmacytoma or solitary plasmacytoma
- Monoclonal gammopathy of undetermined significance
- Smouldering myeloma
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 |
|---|---|---|
| Melphalan | Drug | – |
Primary outcome
Time to treatment failure
5 secondary outcomes
Response rate
Time to response
Tolerance of treatment
Quality of life
Overall survival
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 25 Nov 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.
Heinz Ludwig, MD,Univ.Prof principal investigator
Wilhelminenspital 1st medical dep.-center for oncology and hematology
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 Melphalan in people with Multiple Myeloma, run by Austrian Forum Against Cancer at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. 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 25 Nov 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 Austria. 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?
Time to treatment failure. 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 25 Nov 2013.