- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002787
Vaccine Therapy in Treating Patients With Multiple Myeloma Who Have Undergone Stem Cell Transplantation
Phase I Trial of Post Transplant Immunization With Autologous Myeloma Idiotype-KLH/GM-CSF In Myeloma Patients Following Autologous or Allogeneic Marrow or Stem Cell Transplantation
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the safety of multiple subcutaneous vaccinations with myeloma Id-KLH (idiotype-keyhole limpet hemocyanin) with GM-CSF (sargramostim) in post allogeneic transplant myeloma patients, or with GM-CSF +/- interleukin (IL)-2 (aldesleukin) in post autologous transplant myeloma patients.
II. To evaluate patients pre and post bone marrow transplantation (BMT) for evidence of endogenous idiotype specific immune response.
III. To characterize the time course, specificity and persistence of antibody and T cell immune response to myeloma idiotype and to KLH induced by myeloma Ig (Id) immunization.
IV. To clone, expand and characterize T cells specific for the tumor idiotype. V. Monitor myeloma involvement in bone marrow and serum paraprotein level following vaccination.
VI. Use stored patient samples to clone, expand, and characterize T cells specific for myeloma antigens other than idiotype and identify the antigens they recognize so that they can be used in future studies.
OUTLINE:
Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine combined with sargramostim subcutaneously (SC) in weeks 0, 2, 6, and 10 and sargramostim SC once daily (QD) for three days following each vaccine injection. Some patients also receive aldesleukin SC daily from weeks 2-14.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 1 year.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ELIGIBILITY FOR VACCINE PREPARATION:
- Patients must have a diagnosis of multiple myeloma and be eligible for a Fred Hutchinson Cancer Research Center (FHCRC) treatment protocol using high dose therapy with syngeneic, allogeneic or autologous marrow or stem cell transplantation
- Pretransplant sera available with immunoglobulin A (IgA), immunoglobulin D (IgD), immunoglobulin E (IgE), immunoglobulin G (IgG), or immunoglobulin M (IgM) monoclonal paraprotein with a level of 1.5 grams/dl or greater identifiable on serum protein electrophoresis; eligibility for patients with pretransplant paraprotein levels of less than 1.5 gm/dl will be evaluated on an individual basis to determine whether purification of idiotype is feasible
- ELIGIBILITY FOR POST-TRANSPLANT IDIOTYPE VACCINATION:
- Successful isolation and production of an autologous idiotype vaccine from pre-BMT sera
- Greater than 60 days post BMT
- Achievement of a partial remission or greater (more than 75% reduction in serum paraprotein) for patients transplanted in relapse
- Stable absolute neutrophil count (ANC) > 1000
- Platelet count > 50,000 not requiring transfusions or growth factors
- Red blood cell (RBC) supportable to hematocrit (Hct) > 25 with less than 2 units of packed red blood cell (PRBC)/week
- Treatment with a stable dose of Interferon is allowed
- Karnofsky status > 60 percent
Immunosuppression:
- Off all corticosteroids
- Either off all immunosuppressive medications or on a stable/tapering dose of cyclosporin or FK506 only
Exclusion Criteria:
- Graft-vs-host disease requiring treatment with corticosteroids
- Serum creatinine > 3.0
- Uncontrolled infection
- Disease progression
- Presence of medical complication that in the opinion of the investigators would result in inability to tolerate the vaccination protocol
- Patients with a history of serious adverse reactions to GM-CSF
- Patients with a history of serious adverse reactions to IL-2 will not receive concurrent IL-2 administration but may receive the Id-KLH vaccine with GM-CSF
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (vaccine therapy)
Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine combined with sargramostim SC in weeks 0, 2, 6, and 10 and sargramostim SC QD for three days following each vaccine injection.
Some patients also receive aldesleukin SC daily from weeks 2-14.
|
Correlative studies
Given SC
Other Names:
Given SC
Other Names:
Given SC
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicities graded using the National Cancer Institute (NCI) Common Toxicity Criteria
Time Frame: Up to 2 years
|
Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort.
|
Up to 2 years
|
Immune response
Time Frame: Up to 2 years
|
Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort.
|
Up to 2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Aldesleukin
- Antibodies
- Vaccines
- Immunoglobulins
- Immunoglobulins, Intravenous
- Immunoglobulin Idiotypes
- Sargramostim
- Interleukin-2
- Keyhole-limpet hemocyanin
Other Study ID Numbers
- 1104.00
- NCI-2012-00669 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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