Vaccine Therapy in Treating Patients With Multiple Myeloma

Tracking Information
First Submitted Date ICMJE	March 1, 2007
First Posted Date ICMJE	March 5, 2007
Last Update Posted Date	June 20, 2013
Study 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
Descriptive Information
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
Brief Summary	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.
Detailed Description	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. PROJECTED ACCRUAL: 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
Condition ICMJE	Stage II Multiple Myeloma; Stage III Multiple Myeloma; Refractory Plasma Cell Neoplasm
Intervention ICMJE	Drug: autologous tumor cell vaccine; Drug: keyhole limpet hemocyanin; Drug: melphalan; Drug: sargramostim
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 Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE	Not Provided
Original Enrollment ICMJE	Not Provided
Actual Study 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
Sex/Gender	Not Provided
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
Administrative Information
NCT Number ICMJE	NCT00019097
Other Study ID Numbers ICMJE	CDR0000064244; NCI-97-C-0033B; NCI-T94-0094N; CRB-9409
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
Investigators ICMJE	Study Chair: Larry W. Kwak National Cancer Institute (NCI)
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