Multiple MyelomaPhase 2/3NCT00205751
Thalidomide/Dexamethasone vs MP for Induction Therapy and Thalidomide/Intron A vs Intron A for Maintenance Therapy
A Phase 2/3 study testing Thalidomide/Dexamethasone vs Melphalan/Prednisone in people with Multiple Myeloma, run by Austrian Forum Against Cancer at 1 site in Austria.
Trial summary
This is an international multi-center prospective, double randomized, open, controlled phase III study with a phase II entrance phase to compare the therapeutic efficacy of thalidomide plus dexamethasone to conventional melphalan plus prednisone in newly diagnosed myeloma patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Thalidomide/Dexamethasone vs Melphalan/Prednisone
- How many people
- 350 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2001to Oct 2009
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Multiple Myeloma of IgG, IgA, IgD, IgE, IgM lambda or kappa light chain, low secretory or non-secretory disease
- WHO performance status 0,1,2,or 3
- No prior treatment of multiple myeloma
- Clear requirement of treatment (usually Durie/Salmon stage II or III)
- Anticipated life expectancy of at least 3 months
- Adequate organ function
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- Minimum recovery period of 2 weeks following any major surgical procedure before entry into this study
- Women, who are sterilized via hysterectomy or bilateral tubal ligation or at least one year post-menopausal
- Age of at least 19 years, there is no upper age limit patients must have been informed and must have signed an informed consent
Who cannot join
- Extramedullary plasmocytoma or solitary plasmocytoma without evidence of dissemination of disease
- Benign monoclonal gammopathy
- Multiple myeloma of IgM without osteolytic bone lesions
- Smouldering myeloma
- More than 3 irradiation fields
- Irreversible performance status of WHO4
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- Prior treatment of myeloma with any of the following: chemotherapeutic or immunomodulatory agents, corticosteroids, antiangiogenic agents or other investigational drugs
- Women of childbearing potential
- Preexisting peripheral polyneuropathy
- Congestive heart failure NYHA III, IV
- Acute infection requiring systemic antibiotics at study entry until resolved
- Any uncontrolled underlying medical condition (eg diabetes, glaucoma)
- Second primary malignancy (with the exception of cervical carcinoma in situ and non-myeloma skin malignancies) unless patient has been disease-free for at least three years
Trial locations and contacts
1 site in 1 country.
Austria1 site
Wilhelminenspital, 1st Medical Department-center for oncology and hematology
Vienna, 1190
About this study
Official title: International, Multi-center, Prospective, Double Randomized, Open Phase III Study Evaluating Thalidomide/Dexamethasone Versus Melphalan/Prednisone as Induction Therapy and Thalidomide/Interferon-alpha Versus Interferon-alpha as Maintenance Therapy in Newly Diagnosed Patients With Multiple Myeloma
This is an international multi-center prospective, double randomized, open, controlled phase III study with a phase II entrance phase to compare the therapeutic efficacy of thalidomide plus dexamethasone to conventional melphalan plus prednisone in newly diagnosed myeloma patients.
- Conditions
- Multiple Myeloma
- Being tested
- Thalidomide/Dexamethasone vs Melphalan/Prednisone
- Keywords
- Multiple Myeloma, first line treatment, thalidomide, melphalan
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thalidomide/Dexamethasone vs Melphalan/PrednisoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
Response rate
Secondary outcomes (4)
Survival
Time to response
Toxicity
Quality of life
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 startAug 2001
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 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
- NCT00205751
- Sponsor's protocol ID
- 01-002-0601
- Status last verified
- Nov 2013
- First submitted
- 12 Sep 2005
- Last updated
- 25 Nov 2013
- Results posted
- No
Publications
Ludwig H, Adam Z, Tothova E, Hajek R, Labar B, Egyed M, Spicka I, Gisslinger H, Drach J, Kuhn I, Hinke A, Zojer N. Thalidomide maintenance treatment increases progression-free but not overall survival in elderly patients with myeloma. Haematologica. 2010 Sep;95(9):1548-54. doi: 10.3324/haematol.2009.020586. Epub 2010 Apr 23.
PubMed 20418244Ludwig H, Hajek R, Tothova E, Drach J, Adam Z, Labar B, Egyed M, Spicka I, Gisslinger H, Greil R, Kuhn I, Zojer N, Hinke A. Thalidomide-dexamethasone compared with melphalan-prednisolone in elderly patients with multiple myeloma. Blood. 2009 Apr 9;113(15):3435-42. doi: 10.1182/blood-2008-07-169565. Epub 2008 Oct 27.
PubMed 18955563
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
- International, Multi-center, Prospective, Double Randomized, Open Phase III Study Evaluating Thalidomide/Dexamethasone Versus Melphalan/Prednisone as Induction Therapy and Thalidomide/Interferon-alpha Versus Interferon-alpha as Maintenance Therapy in Newly Diagnosed Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00205751
- Acronym / sponsor ID
- 01-002-0601
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, first line treatment, thalidomide, melphalan
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Austrian Forum Against CancerUniversity, hospital or other
- Study start
- Aug 2001
- 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 multi-center prospective, double randomized, open, controlled phase III study with a phase II entrance phase to compare the therapeutic efficacy of thalidomide plus dexamethasone to conventional melphalan plus prednisone in newly diagnosed myeloma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with Multiple Myeloma of IgG, IgA, IgD, IgE, IgM lambda or kappa light chain, low secretory or non-secretory disease
- WHO performance status 0,1,2,or 3
- No prior treatment of multiple myeloma
- Clear requirement of treatment (usually Durie/Salmon stage II or III)
- Anticipated life expectancy of at least 3 months
Key exclusion criteria (13 listed)
- Extramedullary plasmocytoma or solitary plasmocytoma without evidence of dissemination of disease
- Benign monoclonal gammopathy
- Multiple myeloma of IgM without osteolytic bone lesions
- Smouldering myeloma
- More than 3 irradiation fields
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 |
|---|---|---|
| Thalidomide/Dexamethasone vs Melphalan/Prednisone | Drug | – |
Primary outcome
Time to progression
Response rate
4 secondary outcomes
Survival
Time to response
Toxicity
Quality of life
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.
- Derived from this study: PubMed 20418244Ludwig H, Adam Z, Tothova E, Hajek R, Labar B, Egyed M, Spicka I, Gisslinger H, Drach J, Kuhn I, Hinke A, Zojer N. Thalidomide maintenance treatment increases progression-free but not overall survival in elderly patients with myeloma. Haematologica. 2010 Sep;95(9):1548-54. doi: 10.3324/haematol.2009.020586. Epub 2010 Apr 23.
- Derived from this study: PubMed 18955563Ludwig H, Hajek R, Tothova E, Drach J, Adam Z, Labar B, Egyed M, Spicka I, Gisslinger H, Greil R, Kuhn I, Zojer N, Hinke A. Thalidomide-dexamethasone compared with melphalan-prednisolone in elderly patients with multiple myeloma. Blood. 2009 Apr 9;113(15):3435-42. doi: 10.1182/blood-2008-07-169565. Epub 2008 Oct 27.
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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 2/3 study testing Thalidomide/Dexamethasone vs Melphalan/Prednisone 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 9 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 progression. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00205751, which also lists 2 linked publications.
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.