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Dexamethasone With or Without Oblimersen in Treating Patients With Relapsed or Refractory Multiple Myeloma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Dexamethasone With or Without Oblimersen in Treating Patients With Relapsed or Refractory Multiple Myeloma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Dexamethasone With or Without Oblimersen in Treating Patients With Relapsed or Refractory Multiple Myeloma Clinical research trials and Dexamethasone With or Without Oblimersen in Treating Patients With Relapsed or Refractory Multiple Myeloma health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Dexamethasone With or Without Oblimersen in Treating Patients With Relapsed or Refractory Multiple Myeloma. Dexamethasone With or Without Oblimersen in Treating Patients With Relapsed or Refractory Multiple Myeloma Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Dexamethasone With or Without Oblimersen in Treating Patients With Relapsed or Refractory Multiple Myeloma clinical trial. Test subjects typically receive the most expert healthcare available for their Dexamethasone With or Without Oblimersen in Treating Patients With Relapsed or Refractory Multiple Myeloma condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Dexamethasone With or Without Oblimersen in Treating Patients With Relapsed or Refractory Multiple Myeloma  Dexamethasone With or Without Oblimersen in Treating Patients With Relapsed or Refractory Multiple Myeloma
Dexamethasone With or Without Oblimersen in Treating Patients With Relapsed or Refractory Multiple Myeloma
For Condition: stage 3 multiple myeloma,stage 1 multiple myeloma,refractory plasma cell neoplasm,stage 2 multiple myeloma
Status: No longer recruiting
Sponsor(s): Genta ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of dexamethasone by making cancer cells more sensitive to the drug. It is not yet known if dexamethasone is more effective with or without oblimersen in treating multiple myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of dexamethasone with or without oblimersen in treating patients who have relapsed or refractory multiple myeloma.
Details: OBJECTIVES: - Compare the time to disease progression in patients with relapsed or refractory multiple myeloma treated with dexamethasone with or without oblimersen. - Compare the duration of response and objective response rate in patients treated with these regimens. - Compare the proportion of patients without disease progression after 6 months and the proportion of patients who have not discontinued treatment after 6 months in these two patient groups. - Compare the safety of these regimens in these patients. - Compare survival of patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to response to prior therapy (relapsed vs refractory), prior autologous stem cell transplantation (yes vs no), and number of prior therapy regimens (1-2 vs 3-6). Patients are randomized to 1 of 2 treatment arms. Arm I - Induction: Patients receive oblimersen (G3139) IV continuously on days 1-7 and 15-21 and oral dexamethasone daily on days 4-7, 11-14, and 18-21. - Maintenance: One week after completion of induction therapy, patients with stable or responsive disease receive G3139 IV continuously on days 1-7 and oral dexamethasone daily on days 4-7. Courses repeat every 3 weeks for a maximum of 1 year in the absence of disease progression or unacceptable toxicity. Arm II - Induction: Patients receive oral dexamethasone daily for 4 days on weeks 1-3. - Maintenance: One week after completion of induction therapy, patients with stable or responsive disease receive oral dexamethasone daily for 4 days. Courses repeat every 3 weeks for a maximum of 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 2 years. PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: NOTE: This trial is being conducted at many institutions throughout the country. Please contact Genta for a site near you. - Progressive multiple myeloma defined by one of the following: - Primary resistance or progressive disease after achieving less than a partial response after at least 2 courses of combination chemotherapy (that included at least 1 myelosuppressive drug) within the past 3 months - Relapsed or progressive disease after at least a partial response to prior therapy - Progressive disease after high-dose chemotherapy and autologous stem cell transplantation - Progressive disease defined by at least 1 of the following: - Increase in serum M-protein by at least 50% or at least 2 g/dL above the lowest remission or baseline level - Increase in urinary M-protein by at least 50% or at least 2 g/24 hours above lowest remission or baseline level - Appearance of new lytic bone lesions or at least 50% increase in size of an existing bone lesion - Quantifiable serum and/or urine paraprotein - Bone marrow plasmacytosis at least 5% of total nucleated cells - Measurable disease - Serum M-protein level at least 1.0 g/dL OR - Urinary M-protein excretion at least 200 mg/24 hours PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-3 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,000/mm3 - Platelet count at least 50,000/mm3 - No bleeding or coagulation disorder Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST no greater than 2.5 times ULN - PT and PTT no greater than 1.5 times ULN - No history of chronic hepatitis or cirrhosis Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No active symptoms of coronary artery disease (e.g., uncontrolled arrhythmias or recurrent chest pain despite prophylactic medication) - No New York Heart Association class III or IV heart disease - No uncontrolled congestive heart failure - No grade 2 or greater cardiovascular signs or symptoms within the past 4 weeks Other: - HIV negative - No active peptic ulcer disease - No uncontrolled seizure disorder - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No active uncontrolled infection - No active autoimmune disease - No hypersensitivity to phosphorothioate-containing oligonucleotides or to dexamethasone - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 3 weeks since prior immunotherapy - At least 72 hours since prior thalidomide - Concurrent epoetin alfa allowed Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) Endocrine therapy: - At least 3 weeks since prior corticosteroids - No concurrent chronic corticosteroids Radiotherapy: - At least 14 days since prior radiotherapy except limited radiotherapy to a single bone lesion Surgery: - At least 3 weeks since prior major surgery - No prior organ allograft Other: - At least 4 weeks since other prior investigational therapy - No more than 6 prior therapies for myeloma - No concurrent immunosuppressive therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StanleyFrankel, Study Chair, Genta
Genta Incorporated
Berkeley Heights, New Jersey, 07922
United States
Additional Information:
Study ID Numbers: CDR0000068722; UF-G-29-2001,GENTA-GMY302
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017602
Other Stage 1 Multiple Myeloma Studies:
1. Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma
2. O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma
3. Combination Chemotherapy and Interferon alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma
4. Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
5. Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced Multiple Myeloma
Related Studies:
Other stage 1 multiple myeloma Clinical Trials
Other New Jersey Clinical Trials
Other Berkeley Heights Clinical Trials
Dexamethasone With or Without Oblimersen in Treating Patients With Relapsed or Refractory Multiple Myeloma
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