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Evaluation of Cellular and Humoral Immunity Against the Idiotype in Multiple Myeloma Patients Undergoing Autologous Transplantation After Idiotype Vaccination in an Attempt to Decrease the Risk of Relapse Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Evaluation of Cellular and Humoral Immunity Against the Idiotype in Multiple Myeloma Patients Undergoing Autologous Transplantation After Idiotype Vaccination in an Attempt to Decrease the Risk of Relapse conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Evaluation of Cellular and Humoral Immunity Against the Idiotype in Multiple Myeloma Patients Undergoing Autologous Transplantation After Idiotype Vaccination in an Attempt to Decrease the Risk of Relapse Clinical research trials and Evaluation of Cellular and Humoral Immunity Against the Idiotype in Multiple Myeloma Patients Undergoing Autologous Transplantation After Idiotype Vaccination in an Attempt to Decrease the Risk of Relapse healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Evaluation of Cellular and Humoral Immunity Against the Idiotype in Multiple Myeloma Patients Undergoing Autologous Transplantation After Idiotype Vaccination in an Attempt to Decrease the Risk of Relapse. Evaluation of Cellular and Humoral Immunity Against the Idiotype in Multiple Myeloma Patients Undergoing Autologous Transplantation After Idiotype Vaccination in an Attempt to Decrease the Risk of Relapse Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Evaluation of Cellular and Humoral Immunity Against the Idiotype in Multiple Myeloma Patients Undergoing Autologous Transplantation After Idiotype Vaccination in an Attempt to Decrease the Risk of Relapse clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Evaluation of Cellular and Humoral Immunity Against the Idiotype in Multiple Myeloma Patients Undergoing Autologous Transplantation After Idiotype Vaccination in an Attempt to Decrease the Risk of Relapse condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare 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 > "E" Clinical Trials Conditions > Evaluation of Cellular and Humoral Immunity Against the Idiotype in Multiple Myeloma Patients Undergoing Autologous Transplantation After Idiotype Vaccination in an Attempt to Decrease the Risk of Relapse  Evaluation of Cellular and Humoral Immunity Against the Idiotype in Multiple Myeloma Patients Undergoing Autologous Transplantation After Idiotype Vaccination in an Attempt to Decrease the Risk of Relapse
Evaluation of Cellular and Humoral Immunity Against the Idiotype in Multiple Myeloma Patients Undergoing Autologous Transplantation After Idiotype Vaccination in an Attempt to Decrease the Risk of Relapse
For Condition: Multiple Myeloma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Although high-dose chemoradio therapy with autologous stem cell transplantation has shown some promise in the management of patients with multiple myeloma, relapse of the underlying disease remains the primary cause of treatment failure. This pilot study to explore the possibility that active-specific immunotherapy may be effective in eliminating minimal residual disease remaining after high dose therapy. Experimental studies in patients with lymphoma, as well as a single patient with myeloma have demonstrated the feasibility of immunoglobulin idiotype s a tumor specific antigen for development of therapeutic vaccines against B-cell malignancies. Patients will be immunized with myeloma idiotype protein, made immunogenic by conjugation to a carrier (KLH) and administration with GM-CSF as an immunological adjuvant, at several time points before and after high-dose therapy. The objective of this study is to test whether cellular and humoral immunity can be induced against the unique idiotype expressed on the patient's myeloma pre- and post-transplantation. Patients will receive a series of 3 vaccinations with myeloma Id-KLH (0.5mg) administered s.c. together with GM-CSF (250 ug/m2) for 4 consecutive days 2, 3, and 6 months after high dose therapy with either melphalan/TBI or melphalan/cytoxan followed by autologous peripheral mononuclear stem cell transplantation.
Details: Although high-dose chemoradiotherapy with autologous stem cell transplantation has shown some promise in the management of patients with multiple myeloma, relapse of the underlying disease remains the primary cause of treatment failure. This pilot study to explore the possibility that active-specific immunotherapy may be effective in eliminating minimal residual disease remaining after high dose therapy. Experimental studies in patients with lymphoma, as well as a single patient with myeloma have demonstrated the feasibility of immunoglobulin idiotype s a tumor specific antigen for development of therapeutic vaccines against B-cell malignancies. Patients will be immunized with myeloma idiotype protein, made immunogenic by conjugation to a carrier (KLH) and administration with GM-CSF as an immunological adjuvant, at several timepoints before and after high-dose therapy. The objective of this study is to test whether cellular and humoral immunity can be induced against the unique idiotype expressed on the patient's myeloma pre- and post-transplantation. Patients will receive a series of 3 vaccinations with myeloma Id-KLH (0.5mg) administered s.c. together with GM-CSF (250 micrograms/m2) for 4 consecutive days 2, 3, and 6 months after high dose therapy with either melphalan/TBI or melphalan/cytoxan followed by autologous peripheral mononuclear stem cell transplantation.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients with IgG or IgA multiple myeloma who are classified as low-or-intermediate-risk on the basis of the following University of Arkansas algorithm are eligible: a) cytogenetics: no translocations, no 11q, no-13/13q- and b) beta-2 microglobulin less than 2.5 mg/L pre-AT#1. Patients who attain at least a PR prior to second transplantation are eligible. All previous therapy must be completed at least eight weeks prior to scheduled second transplantation. Patients should have recovered from all hematologic and non-hematologic toxicity of previous therapy. Steroids must be discontinued at least four weeks prior to vaccination. Patients must meet the following criteria: Karnofsky performance status greater than or equal to 70%. Life expectancy greater than 8 weeks, and absence of co-existing medical problems which would significantly increase the risk of the transplant procedure in the judgment of the bone marrow transplant attending physicians. Creatinine less than 2.0 normal and not rising, for at least 2-4 weeks before transplantation. If creatinine is elevated, then creatinine clearance must be greater than 40 ml/min. Direct bilirubin less than 2 mg/dl, SGOT less than or equal to 4 times top normal, and none of these parameters increasing, for at least 2-4 weeks before transplantation. Patients must be HIV-negative. M-protein concentration in the harvested plasma must be greater than 50% of the total Ig of the corresponding isotype. M-protein must be able to be purified by either protein A- or anti-IgA-sepharose. Age greater than or equal to 18 years. Patients must not be pregnant or lactating. Patients of childbearing potential must use an effective method of contraception. Patients must not have received an autotransplant with CD34 selected stem cells.
Total Enrollment: 60
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 970033; 97-C-0033
Study Start Date: November 21, 1996
Record last reviewed: October 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001562
Other Multiple Myeloma Studies:
1. Thalidomide-Dexamethasone for Multiple Myeloma
2. Safety Study of AP23573 in Patients with Advanced, Refractory or Recurrent Malignancies
3. A Phase II Study of Continuous versus Syncopated Dosing of CC-5013 for the Treatment of Refractory Multiple Myeloma
4. Thalidomide for Multiple Myeloma
5. Ribavirin With or Without Monoclonal Antibody Therapy in Treating Patients Who Develop RSV Pneumonia Following Peripheral Stem Cell Transplantation
Related Studies:
Other Multiple Myeloma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Evaluation of Cellular and Humoral Immunity Against the Idiotype in Multiple Myeloma Patients Undergoing Autologous Transplantation After Idiotype Vaccination in an Attempt to Decrease the Risk of Relapse
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