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Vaccine Therapy in Treating Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00019097
First received: March 1, 2007
Last updated: June 19, 2013
Last verified: May 2006

March 1, 2007
June 19, 2013
July 1995
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Complete list of historical versions of study NCT00019097 on ClinicalTrials.gov Archive Site
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Vaccine Therapy in Treating Patients With Multiple Myeloma
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.

PROJECTED ACCRUAL:

A maximum of 60 patients (20 per treatment group) will be accrued for this study within 3 years.

Interventional
Phase 2
Primary Purpose: Treatment
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Refractory Plasma Cell Neoplasm
  • Drug: autologous tumor cell vaccine
  • Drug: keyhole limpet hemocyanin
  • Drug: melphalan
  • Drug: sargramostim
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 2007
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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

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18 Years and older
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00019097
CDR0000064244, NCI-97-C-0033B, NCI-T94-0094N, CRB-9409
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National Cancer Institute (NCI)
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Study Chair: Larry W. Kwak National Cancer Institute (NCI)
National Cancer Institute (NCI)
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP