|
|
|
|
|
|
Sponsored by: |
Austrian Forum Against Cancer |
Information provided by: | Austrian Forum Against Cancer |
ClinicalTrials.gov Identifier: | NCT00205764 |
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
Condition | Intervention | Phase |
Multiple Myeloma |
Drug: Melphalan |
Phase III |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Multiple Myeloma |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy 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 |
Estimated Enrollment: | 212 |
Study Start Date: | March 1999 |
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.
Ages Eligible for Study: | 19 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Heinz Ludwig, MD,Univ.Prof | +43-1-49150 ext 2101 | heinz.ludwig@wienkav.at |
Austria | |||||
Wilhelminenspital, 1st Medical Department-center for oncology and hematology | Recruiting | ||||
Vienna, Austria, 1160 | |||||
Contact: Heinz Ludwig, MD,Univ.Prof +43-1-49150 ext 2101 heinz.ludwig@wienkav.at | |||||
Principal Investigator: Heinz Ludwig, MD,Univ.Prof |
Austrian Forum Against Cancer |
Principal Investigator: | Heinz Ludwig, MD,Univ.Prof | Wilhelminenspital 1st medical dep.-center for oncology and hematology |
Study ID Numbers: | 03/99 |
First Received: | September 12, 2005 |
Last Updated: | September 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00205764 |
Health Authority: | Austria: Federal Ministry for Health and Women |
|
|
|
|
|