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Id-KLH Vaccine + T Cells

This study is currently recruiting participants.
Verified February 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01426828
First received: August 30, 2011
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

This study will enroll myeloma subjects undergoing autotransplantation. The primary objective of this study is to evaluate whether infusions of Id-KLH primed CD3/CD28 activated autologous lymphocytes mediate a more intense Id-specific immunity than non Id-KLH primed CD3/CD28 activated autologous lymphocytes. There will be 2 arms in the study, one receiving a DLI with non Id-KLH vaccine and one receiving aDLI with Id-KLH vaccine.


Condition Intervention Phase
Multiple Myeloma
 Biological: CD3/CD28
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of CD3/CD28 Activated Id-KLH Primed Autologous Lymphocytes in Patients With Myeloma Undergoing Autologous Transplant

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Adverse Events [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm A
Arm A will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of "KLH only" vaccine.
 Biological: CD3/CD28
CD3/CD28 activated autologous lymphocytes intravenously
Arm B
Arm B will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of ID-KLH Vaccine Myeloma Immunoglobulin Idiotype Vaccine (id-KLH vaccine)
 Biological: CD3/CD28
CD3/CD28 activated autologous lymphocytes intravenously

Detailed Description:

The primary objectives of this study is to evaluate whether infusions of Id-KLH primed CD3/CD28 activated autologous lymphocytes mediate a more intense id-specific immunity than non id-KLH primed CD3/CD28 activated autologous lymphocytes. The secondary objectives of this study is to demonstrate that doses of 1 times 10e10 Id-KLH primed CD3/CD28 autologous lymphocytes can be infused safely and effectively in more than 80 percent of eligible patients, to determine whether Id-KLH primed CD3/CD28 activated autologous lymphocytes and to determine if the presence of Id-specific immunity correlates with disease response.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: (Vaccine Production)

  • Diagnosis of symptomatic multiple myeloma with 12 months of initiation of systemic therapy.
  • Age greater than or equal to 18 years to less than 70 years.
  • IgG subtype with a paraprotein peak of at least 0.2 gms/dl and whose paraprotein peak represents at least 70% of the IgG subtype. Alternatively patients who have previously stored purified id-specific protein on other clinical or laboratory protocols.
  • Echocardiogram or MUGA with an ejection fraction of 45% or more and no uncompensated congestive heart failure or uncontrolled arrhythmias.
  • Adequate pulmonary function as defined by FEV1, FVC and corrected DLCO of 50% or greater of the predicted value for age, sex and size.
  • Adequate renal function as defined by creatinine of 2.0 mg/dl or less and/or a calculated or measured creatinine clearance of 40 cc/min or more.
  • Adequate hepatic function as defined by a total bilirubin of 2.0 mg/dl or less and liver enzyme of less than 2 times upper limit of normal.
  • Ability to sign written informed consent.
  • Karnofsky performance status of at least 80% or more.
  • Negative serum Beta HCG test in women with child bearing potential.

Inclusion - Vaccine Administration

  • Diagnosis of symptomatic multiple myeloma within 12 months of initiation of systemic therapy.
  • Age greater than or equal to 18 years to less than 70 years.
  • Adequate renal function as defined by creatinine of 2.0 mg/dl or less and/or a calculated or measured creatinine Adequate hepatic function as defined by a total bilirubin of 2.0 mg/dl or less and liver enzyme of less than 2 times upper limit of normal.
  • Karnofsky performance status of at least 80% or more.
  • At least 2 weeks from last chemotherapy.
  • Able to sign written informed consent.
  • Negative serum Beta HCG test in women with child bearing potential.

Exclusion Criteria:

  • Active uncontrolled infection
  • HIV + or active hepatitis B or C as defined by positive viral load or serology.
  • Pre-existing autoimmune diseases, with exception of Hashimoto's thyroiditis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426828

Contacts
Contact: Ed Stadtmauer, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ed Stadtmauer, MD     855-216-0098     PennCancerTrials@emergingmed.com    
Principal Investigator: Ed Stadtmauer, MD            
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Ed Stadtmauer, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01426828     History of Changes
Other Study ID Numbers: UPCC 07409
Study First Received: August 30, 2011
Last Updated: February 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
adult
symptomatic multiple myeloma
myeloma
diagnosis within 12 months of initiation of systemic therapy

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013