Vaccine Therapy in Treating Patients With Multiple Myeloma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 Start Date: | July 1995 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
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
Contacts and Locations| United States, Arkansas | |
| Arkansas Cancer Research Center | |
| Little Rock, Arkansas, United States, 72205 | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, Maryland | |
| Medicine Branch | |
| Bethesda, Maryland, United States, 20892 | |
| Study Chair: | Larry W. Kwak | National Cancer Institute (NCI) |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00019097 History of Changes |
| Obsolete Identifiers: | NCT00001562 |
| Other Study ID Numbers: | CDR0000064244, NCI-97-C-0033B, NCI-T94-0094N, CRB-9409 |
| Study First Received: | March 1, 2007 |
| Last Updated: | March 1, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
Immunoglobulin Idiotypes Melphalan Keyhole-limpet hemocyanin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Myeloablative Agonists Immunosuppressive Agents Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 16, 2013