Vaccine Therapy in Treating Patients With Multiple Myeloma
|First Submitted Date ICMJE||March 1, 2007|
|First Posted Date ICMJE||March 5, 2007|
|Last Update Posted Date||June 20, 2013|
|Start Date ICMJE||July 1995|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00019097 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Vaccine Therapy in Treating Patients With Multiple Myeloma|
|Official Title ICMJE||Phase II Study of Autologous Myeloma-Derived Immunoglobulin Idiotype Conjugated to Keyhole Limpet Hemocyanin Plus Sargramostim (GM-CSF) in Patients With Multiple Myeloma Undergoing Second Autologous Peripheral Blood Stem Cell Transplantation|
RATIONALE: Vaccines made from a person's tumor cells may make the body build an immune response and kill their tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus vaccine therapy and chemotherapy in treating patients who have multiple myeloma.
OBJECTIVES: I. Determine whether autologous myeloma-derived immunoglobulin idiotype conjugated to keyhole limpet hemocyanin plus sargramostim (GM-CSF) can induce cellular and humoral immunity against the unique idiotype expressed on the surface of myeloma cells in patients with multiple myeloma undergoing second autologous peripheral blood stem cell transplantation.
II. Determine the clinical efficacy and safety of this regimen in these patients.
PROTOCOL OUTLINE: Within 6 months after the first autologous peripheral blood stem cell transplantation (APBSCT), patients receive melphalan IV over 30 minutes on day -2 and the second APBSCT on day 0. Sargramostim (GM-CSF) is administered subcutaneously (SC) beginning on day 1 and continuing until blood counts recover. Patients are also assigned to 1 of 3 vaccination groups.
Group 1: Patients receive autologous myeloma-derived immunoglobulin idiotype conjugated to keyhole limpet hemocyanin (Id-KLH) SC on day 1 and GM-CSF SC on days 1-4 of months 2, 3, and 5 after the second APBSCT for a total of 3 vaccinations.
Group 2: Patients receive Id-KLH SC on day 1 and GM-CSF SC on days 1-4 of months 2, 3, 4, 5, 6, and 8 after the second APBSCT for a total of 6 vaccinations.
Group 3: Patients receive Id-KLH SC on day 1 and GM-CSF SC on days 1-4 of weeks -8, -6, and -2 before and months 2, 3, and 5 after the second APBSCT for a total of 6 vaccinations.
Patients are followed within 3 months and then every 6 months.
A maximum of 60 patients (20 per treatment group) will be accrued for this study within 3 years.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||March 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Immunoglobulin G or immunoglobulin A (IgA) multiple myeloma Low or intermediate risk disease based on the following criteria: Cytogenetics: no translocations, 11q, or -13/13q- Beta-2 microglobulin less than 2.5 mg/L before the first autologous peripheral blood stem cell transplantation (APBSCT) M-protein concentration in harvested plasma greater than 50% of total immunoglobulin of corresponding isotype (M-protein must be able to be purified by protein A- or anti-IgA-sepharose) Patients achieving partial or complete response after the first APBSCT eligible --Prior/Concurrent Therapy-- Biologic therapy: See Disease Characteristics No prior APBSCT with CD34 selected stem cells Chemotherapy: Not specified Endocrine therapy: Steroids must be discontinued at least 4 weeks prior to vaccination No concurrent steroids Radiotherapy: Not specified Surgery: Not specified Other: Any prior therapy must be completed at least 8 weeks prior to second APBSCT Recovered from the toxic effects of prior therapy No concurrent aspirin or nonsteroidal antiinflammatory drugs --Patient Characteristics-- Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: More than 8 weeks Hepatic: Bilirubin less than 2.0 mg/dL and not rising for at least 2-4 weeks before transplantation SGOT no greater than 4 times upper limit of normal and not rising for at least 2-4 weeks before transplantation Renal: Creatinine less than 2 times normal and not rising for at least 2-4 weeks before transplantation OR Creatinine clearance greater than 40 mL/min Cardiovascular: LVEF greater than 50% by MUGA scan Pulmonary: DLCO greater than 50% predicted Other: No other medical condition that would increase risk of transplantation HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Not Provided|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00019097|
|Other Study ID Numbers ICMJE||CDR0000064244
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||May 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP