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Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma Clinical research trials and Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma. Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma clinical trial. Test subjects typically receive the most effective healthcare possible for their Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma  Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma
Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma
For Condition: stage 2 multiple myeloma,stage 3 multiple myeloma
Status: Recruiting
Sponsor(s): Commissie Voor Klinisch Toegepast Onderzoek ,
Synopsis: 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 tumor. It is not yet known if combination chemotherapy is more effective with or without thalidomide in treating multiple myeloma. PURPOSE: Randomizedphase III trial to compare the effectiveness of combination chemotherapy with or without thalidomide in treating patients who have multiple myeloma.
Details: OBJECTIVES: - Compare the efficacy of doxorubicin, dexamethasone, and high-dose melphalan with versus without thalidomide, in terms of event-free survival, of patients with multiple myeloma. - Determine the response rate, complete response rate, overall survival, and progression-free survival of patients treated with these regimens. - Determine the safety and toxicity of thalidomide in combination with intensive chemotherapy in these patients. - Assess the value of prognostic factors at diagnosis in individual patients treated with these regimens. 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: - Patients receive induction chemotherapy (AD) comprising doxorubicin IV on days 1-4 and oral dexamethasone on days 1-4, 9-12, and 17-20. Patients receive oral thalidomide daily beginning on day 1 and continuing until 2 weeks before start of stem cell mobilization. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. - Patients receive stem cell mobilization with chemotherapy comprising cyclophosphamide IV on day 1 and doxorubicin IV and oral dexamethasone on days 1-4 (CAD). Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until last apheresis. - Beginning 8-10 weeks after stem cell collection, patients receive low-dose oral thalidomide daily and high-dose melphalan IV on days -3 and -2 as intensification. Patients undergo stem cell infusion on day 0. Patients may receive a second course of high-dose melphalan 2-3 months after the first course, in which case, stem cell infusion follows the second course of melphalan. - Patients receive maintenance therapy with oral thalidomide daily until disease progression or after 3 months if no response. - Beginning 2 months after the last course, patients with an HLA-identical sibling donor undergo nonmyeloablative stem cell transplantation after radiotherapy. Arm II: - Patients receive induction chemotherapy (VAD) comprising vincristine IV and doxorubicin IV on days 1-4 and dexamethasone on days 1-4, 9-12, and 17-20. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. - Patients receive stem cell mobilization with CAD chemotherapy as in arm I. G-CSF is given as in arm I. - Patients receive high-dose melphalan and undergo stem cell infusion as in arm I. - Patients receive maintenance therapy with interferon alfa SC 3 times weekly until progression or after 3 months if no partial response. - Beginning 2 months after the last course, patients with an HLA-identical sibling donor undergo nonmyeloablative stem cell transplantation after radiotherapy. 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed multiple myeloma - Stage II or III - No systemic amyloid light-chain amyloidosis PATIENT CHARACTERISTICS: Age: - 18 to 65 Performance status: - WHO 0-3 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - No significant hepatic dysfunction* - Bilirubin less than 1.75 mg/dL* - AST/ALT less than 2.5 times normal* NOTE: *Unless related to myeloma Renal: - Not specified Cardiovascular: - No severe cardiac dysfunction - No New York Heart Association class II, III, or IV heart disease Other: - HIV negative - No active uncontrolled infection - No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix - No known intolerance to thalidomide - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Patients 18 to 55 years of age must not have been allocated before study randomization to allogeneic stem cell transplantation with an HLA-identical sibling donor Chemotherapy: - No more than 2 prior courses of melphalan and prednisone therapy for local myeloma progression - No other prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Prior local radiotherapy for local myeloma progression allowed - No other prior radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
H.Lokhorst, Study Chair, Academisch Ziekenhuis Utrecht
Academisch Ziekenhuis Maastricht *Recruiting*
Maastricht, , 6202 AZ
Netherlands
Recruiting G.M.J. BOS 31-43-387-6543
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting G.E.G. Verhoef 32-16-34608
Medisch Centrum Leeuwarden - Zuid *Recruiting*
Leeuwarden, , 8934 AD
Netherlands
Recruiting P. Joosten 31-58-286-6965
Leiden University Medical Center *Recruiting*
Leiden, , 2300 CA
Netherlands
Recruiting C.M. Segeren 31-71-526-2267
Vrije Universiteit Medisch Centrum *Recruiting*
Amsterdam, , 1081HV
Netherlands
Recruiting P.C. Huijgens 31-20-444-2604
Medisch Spectrum Twente *Recruiting*
ENSCHEDE, , 7500 KA
Netherlands
Recruiting M.R. Schaafsma 31-53-487-2444
Academisch Medisch Centrum *Recruiting*
Amsterdam, , 1105 AZ
Netherlands
Recruiting M.H.J. Oers 31-20-566-5785
Academisch Ziekenhuis Groningen *Recruiting*
Groningen, , 9713 EZ
Netherlands
Recruiting Edo Vellenga 31-50-361-6161
Groot Ziekengasthuis 's-Hertogenbosch *Recruiting*
's-Hertogenbosch, , 5211 NL
Netherlands
Recruiting H.A.M. Sinnige 31 73 6162452
Leyenburg Ziekenhuis *Recruiting*
's-Gravenhage, , 2545 CH
Netherlands
Recruiting P.W. Wijermans 31-070-3592556
University Medical Center Nijmegen *Recruiting*
Nijmegen, , NL-6500 HB
Netherlands
Recruiting A.J. Croockewit 31-24-361-1111
Academisch Ziekenhuis Utrecht *Recruiting*
Utrecht, , 3584 CX
Netherlands
Recruiting H. Lokhorst 30-250-7230
Meander Medisch Centrum *Recruiting*
Amersfoort, , 3816 CP
Netherlands
Recruiting S. Wittebol 00-31-33-4222345
Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam, , 3008 AE
Netherlands
Recruiting J.J. Cornelissen 10-4391367
Sint Antonius Ziekenhuis *Recruiting*
Nieuwegein, , 3435 CM
Netherlands
Recruiting O Weerdt 31-30-609-2052
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital *Recruiting*
Amsterdam, , 1066 CX
Netherlands
Recruiting J. Baars 31-20-512-2570 or 512-2568
Isala Klinieken - locatie Sophia *Recruiting*
Zwolle, , 8000 GK
Netherlands
Recruiting Marinus Marwijk Kooij 31-38-424-7039
Additional Information:
Study ID Numbers: CDR0000069144; HOVON-CKVO-2001-02,HOVON-50MM,EU-20133,CKVO-2001-02
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028886
Other Stage 3 Multiple Myeloma Studies:
1. Dexamethasone With or Without CC-5013 in Treating Patients With Newly Diagnosed Multiple Myeloma
2. Combination Chemotherapy in Treating Patients With Multiple Myeloma
3. Melphalan, Peripheral Stem Cell Transplantation, and Radiation Therapy in Treating Patients With Multiple Myeloma
4. CC-5013 in Treating Patients With Advanced Multiple Myeloma
5. Dexamethasone With or Without Oblimersen in Treating Patients With Relapsed or Refractory Multiple Myeloma
Related Studies:
Other stage 3 multiple myeloma Clinical Trials
Other Clinical Trials
Other Nijmegen Clinical Trials
Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma
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