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Vaccine Therapy in Treating Patients With Multiple Myeloma

Primary Purpose

Stage II Multiple Myeloma, Stage III Multiple Myeloma, Refractory Plasma Cell Neoplasm

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
autologous tumor cell vaccine
keyhole limpet hemocyanin
melphalan
sargramostim
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage II Multiple Myeloma focused on measuring body system/site cancer, cancer, genetic condition, hematopoietic/lymphoid cancer, multiple myeloma, multiple myeloma and other plasma cell neoplasms, plasma cell neoplasm, refractory plasma cell neoplasm, stage II multiple myeloma, stage III multiple myeloma, stage, plasma cell neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)

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

Sites / Locations

  • Arkansas Cancer Research Center
  • University of Arkansas for Medical Sciences
  • Medicine Branch

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 1, 2007
Last Updated
June 19, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00019097
Brief Title
Vaccine Therapy in Treating Patients With Multiple Myeloma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
July 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage II Multiple Myeloma, Stage III Multiple Myeloma, Refractory Plasma Cell Neoplasm
Keywords
body system/site cancer, cancer, genetic condition, hematopoietic/lymphoid cancer, multiple myeloma, multiple myeloma and other plasma cell neoplasms, plasma cell neoplasm, refractory plasma cell neoplasm, stage II multiple myeloma, stage III multiple myeloma, stage, plasma cell neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
autologous tumor cell vaccine
Intervention Type
Drug
Intervention Name(s)
keyhole limpet hemocyanin
Intervention Type
Drug
Intervention Name(s)
melphalan
Intervention Type
Drug
Intervention Name(s)
sargramostim

10. Eligibility

Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry W. Kwak
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Arkansas Cancer Research Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Medicine Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

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Vaccine Therapy in Treating Patients With Multiple Myeloma

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