|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Commissie Voor Klinisch Toegepast Onderzoek |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00028886 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect). It is not yet known whether chemotherapy followed by peripheral blood stem cell transplant is more effective with or without thalidomide in treating multiple myeloma.
PURPOSE: This randomized phase III trial is studying giving combination chemotherapy with thalidomide to see how well it works compared with giving combination chemotherapy without thalidomide in treating patients with multiple myeloma.
| Condition | Intervention | Phase |
|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: cyclophosphamide Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: filgrastim Drug: melphalan Drug: recombinant interferon alfa Drug: thalidomide Drug: vincristine sulfate Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
Phase III |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Cancer Multiple Myeloma |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomized Phase III Study On The Effect Of Thalidomide Combined With Adriamycin, Dexamethasone (AD) And High Dose Melphalan In Patients With Multiple Myeloma |
| Estimated Enrollment: | 450 |
| Study Start Date: | March 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and treatment policy (1 course vs 2 courses of high-dose melphalan). Patients are randomized to 1 of 2 treatment arms.
Arm I:
Arm II:
All patients are followed every 6 months for 3 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 450 patients (225 per treatment arm) will be accrued for this study within 4 years.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed multiple myeloma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| Belgium | |||||
| U.Z. Gasthuisberg | |||||
| Leuven, Belgium, B-3000 | |||||
| Netherlands | |||||
| Academisch Medisch Centrum at University of Amsterdam | |||||
| Amsterdam, Netherlands, 1105 AZ | |||||
| Academisch Ziekenhuis Maastricht | |||||
| Maastricht, Netherlands, 6202 AZ | |||||
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | |||||
| Rotterdam, Netherlands, 3008 AE | |||||
| HagaZiekenhuis - Locatie Leyenburg | |||||
| 's-Gravenhage, Netherlands, 2545 CH | |||||
| Isala Klinieken - locatie Sophia | |||||
| Zwolle, Netherlands, 8000 GK | |||||
| Jeroen Bosch Ziekenhuis | |||||
| 's-Hertogenbosch, Netherlands, 5211 NL | |||||
| Leiden University Medical Center | |||||
| Leiden, Netherlands, 2300 RC | |||||
| Vrije Universiteit Medisch Centrum | |||||
| Amsterdam, Netherlands, 1081HV | |||||
| Medisch Centrum Leeuwarden - Zuid | |||||
| Leeuwarden, Netherlands, 8934 AD | |||||
| Medisch Spectrum Twente | |||||
| Enschede, Netherlands, 7500 KA | |||||
| Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | |||||
| Amsterdam, Netherlands, 1066 CX | |||||
| Sint Antonius Ziekenhuis | |||||
| Nieuwegein, Netherlands, 3435 CM | |||||
| Universitair Medisch Centrum St. Radboud - Nijmegen | |||||
| Nijmegen, Netherlands, NL-6500 HB | |||||
| University Medical Center Groningen | |||||
| Groningen, Netherlands, 9713 EZ | |||||
| University Medical Center Utrecht | |||||
| Utrecht, Netherlands, 3584 CX | |||||
| Meander Medisch Centrum | |||||
| Amersfoort, Netherlands, 3816 CP | |||||
| Commissie Voor Klinisch Toegepast Onderzoek |
| Study Chair: | H. Lokhorst, MD, PhD | University Medical Center Utrecht |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000069144, CKTO-2001-02, HOVON-50MM, EU-20133, HOVON-CKVO-2001-02 |
| First Received: | January 4, 2002 |
| Last Updated: | October 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00028886 |
| Health Authority: | United States: Federal Government |
|
|
|
|
|