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Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma Clinical research trials and Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma. Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma clinical trial. Human subjects often obtain the finest healthcare possible for their Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma  Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
For Condition: refractory plasma cell neoplasm
Status: Recruiting
Sponsor(s): University of Maryland Greenebaum Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Thalidomide may slow the growth of cancer cells. Oblimersen may increase the effectiveness of thalidomide and dexamethasone by making cancer cells more sensitive to the drugs. PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and dexamethasone with oblimersen in treating patients who have relapsed or refractorymultiple myeloma.
Details: OBJECTIVES: - Determine the clinical efficacy of oblimersen, thalidomide, and dexamethasone, in terms of complete and partial response rates, in patients with relapsed or refractory multiple myeloma. - Determine the time to progression and duration of response in patients treated with this regimen. - Determine the toxicity of this regimen in these patients. - Correlate disease response (clinical outcome) with changes in Bcl-2 levels in patients treated with this regimen. - Determine the disease-free and overall survival of patients treated with this regimen. OUTLINE: Patients receive induction therapy comprising oblimersen IV continuously on days 1-7, 22-28, and 43-49, oral dexamethasone on days 4-7, 25-28, and 46-49, and oral thalidomide daily beginning on day 4. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable disease after induction therapy receive maintenance therapy comprising oblimersen IV continuously on days 1-7, oral dexamethasone on days 4-7, and oral thalidomide daily. Courses repeat every 35 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients are followed for 3 years. PROJECTED ACCRUAL: A total of 10-46 patients will be accrued for this study within 10 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically and clinically confirmed multiple myeloma - Relapsed and/or refractory after chemotherapy or transplantation - Patients with prior allogeneic transplantation must not have evidence of active graft-vs-host disease requiring immune suppression - Measurable disease defined by quantitative immune globulin levels in serum and/or urine and bone marrow plasmacytosis - Patients with nonsecretory disease are eligible provided at least 1 plasmacytoma lesion is accurately measurable by MRI or CT scan - No known CNS involvement PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 3 months Hematopoietic - See Disease Characteristics - Absolute neutrophil count at least 1,000/mm^3* - Platelet count at least 50,000/mm - * NOTE: *Unless secondary to bone marrow plasmacytosis (more than 80% involvement) Hepatic - Bilirubin less than 2 times normal - AST/ALT no greater than 3 times upper limit of normal Renal - Creatinine no greater than 2 mg/dL Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Seizures allowed if under adequate control - No severe skin reactions from prior thalidomide - No prior allergic reactions attributed to agents used in this study - No sensory or motor neuropathy grade II or greater - No other uncontrolled concurrent illness that would preclude study therapy - No ongoing or active infection - No psychiatric illness or social situations that would preclude study compliance - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 2 effective methods of contraception for 1 month before, during, and for 1 month after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - See Chemotherapy - At least 6 weeks since prior thalidomide Chemotherapy - See Disease Characteristics - No more than 4 prior chemotherapy regimens, including autologous and/or allogeneic stem cell transplantation regimens - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy - Concurrent continuous steroids allowed for chronic treatment of disorders other than myeloma Radiotherapy - Not specified Surgery - Not specified Other - No prior oblimersen - No other concurrent anticancer therapies or investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AshrafBadros, Study Chair, University of Maryland Greenebaum Cancer Center
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201-1592
United States
Recruiting Ashraf Badros 410-328-2565
Additional Information:
Study ID Numbers: CDR0000258058; NCI-5824,MSGCC-210421
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049374
Other Refractory Plasma Cell Neoplasm Studies:
1. O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma
2. Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma
3. Combination Chemotherapy in Treating Patients With Multiple Myeloma
4. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
5. Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma
Related Studies:
Other refractory plasma cell neoplasm Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
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