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Vaccine Therapy Plus GM-CSF in Treating Patients With Multiple Myeloma Undergoing Bone Marrow or Peripheral Stem Cell Transplantation 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 Vaccine Therapy Plus GM-CSF in Treating Patients With Multiple Myeloma Undergoing Bone Marrow or Peripheral Stem Cell Transplantation conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Vaccine Therapy Plus GM-CSF in Treating Patients With Multiple Myeloma Undergoing Bone Marrow or Peripheral Stem Cell Transplantation Clinical research trials and Vaccine Therapy Plus GM-CSF in Treating Patients With Multiple Myeloma Undergoing Bone Marrow or Peripheral Stem Cell Transplantation 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 Vaccine Therapy Plus GM-CSF in Treating Patients With Multiple Myeloma Undergoing Bone Marrow or Peripheral Stem Cell Transplantation. Vaccine Therapy Plus GM-CSF in Treating Patients With Multiple Myeloma Undergoing Bone Marrow or Peripheral Stem Cell Transplantation 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 Vaccine Therapy Plus GM-CSF in Treating Patients With Multiple Myeloma Undergoing Bone Marrow or Peripheral Stem Cell Transplantation clinical trial. Test subjects typically receive the most effective healthcare possible for their Vaccine Therapy Plus GM-CSF in Treating Patients With Multiple Myeloma Undergoing Bone Marrow or Peripheral Stem Cell Transplantation 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 > "V" Clinical Trials Conditions > Vaccine Therapy Plus GM-CSF in Treating Patients With Multiple Myeloma Undergoing Bone Marrow or Peripheral Stem Cell Transplantation  Vaccine Therapy Plus GM-CSF in Treating Patients With Multiple Myeloma Undergoing Bone Marrow or Peripheral Stem Cell Transplantation
Vaccine Therapy Plus GM-CSF in Treating Patients With Multiple Myeloma Undergoing Bone Marrow or Peripheral Stem Cell Transplantation
For Condition: stage 1 multiple myeloma,stage 2 multiple myeloma,stage 3 multiple myeloma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fred Hutchinson Cancer Research Center
Synopsis: RATIONALE: Vaccines may make the body build an immune response to and kill tumor cells. Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone marrow or peripheral blood. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus GM-CSF in treating patients with multiple myeloma undergoing bone marrow or peripheral stem cell transplantation.
Details: OBJECTIVES: I. Determine the safety of multiple subcutaneous vaccination with myeloma Id-KLH with adjuvant sargramostim (GM-CSF) in posttransplant myeloma patients. II. Evaluate patients' pre- and post-bone marrow transplants for evidence of endogenous idiotype specific immune response. III. Characterize the time course, specificity and persistence of antibody and T cell immune response to myeloma idiotype and to KLH induced by myeloma Ig (Id) immunization. IV. Clone, expand, and characterize T cell clones specific for the tumor idiotype. V. Monitor myeloma involvement in bone marrow and serum paraprotein level following vaccination. PROTOCOL OUTLINE: Patients more than 60 days posttransplant are vaccinated with autologous idiotype vaccine at 0, 2, 6, and 10 weeks. Allogeneic recipients are vaccinated after they are off corticosteroids and on a stable or tapering dose of cyclosporine or tacrolimus (FK506). A series of 4 subcutaneous injections of autologous Id-KLH is given with 3 additional daily injections of GM-CSF subcutaneously at the same site. PROJECTED ACCRUAL: 35-40 patients will be entered.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven multiple myeloma of late stage B cells - Eligible for a FHCRC protocol using high dose therapy with syngeneic, allogeneic, or autologous marrow or stem cell transplantation - Achievement of partial or greater remission for patients transplanted in relapse --Prior/Concurrent Therapy-- - No concurrent posttransplant immunomodulation with IL-2 --Patient Characteristics-- - Age: 18 to 65 - Performance status: Karnokfsky 60-100% - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count greater than 1000/mm3; Platelet count greater than 50,000/mm3 without transfusions or growth factors; RBC supportable to hematocrit greater than 25 with less than 2 units of packed RBC/week - Hepatic: Not specified - Renal: Creatinine no greater than 3.0 mg/dL - Other: Must have pretransplant sera available with IgG, IgA, or IgM monoclonal paraprotein with a level of 1.5 g/dL or greater identifiable on serum protein electrophoresis; Successful isolation and production of an autologous idiotype vaccine from pre-BMT sera; Must be off corticosteroids prior to vaccination; No infections; No disease progression after transplant; No graft versus host disease (GVHD) at vaccination; No medical conditions that would result in inability to tolerate the vaccination; No prior history of serious adverse reactions to GM-CSF
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidMaloney, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States
Additional Information:
Study ID Numbers: CDR0000064851; FHCRC-1104.00,NCI-H96-0924
Study Start Date: March 1996
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002787
Other Stage 2 Multiple Myeloma Studies:
1. Phase III Randomized Study of Melphalan With or Without Holmium Ho 166 DOTMP Followed By Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma
2. CCI-779 in Treating Patients With Relapsed or Refractory Multiple Myeloma
3. Dexamethasone With or Without CC-5013 in Treating Patients With Newly Diagnosed Multiple Myeloma
4. Beta Alethine in Treating Patients With Myeloma
5. Interleukin-12 in Treating Patients With Multiple Myeloma
Related Studies:
Other stage 2 multiple myeloma Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Vaccine Therapy Plus GM-CSF in Treating Patients With Multiple Myeloma Undergoing Bone Marrow or Peripheral Stem Cell Transplantation
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