Id-KLH Vaccine + T Cells

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 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: January 12, 2016
Last verified: January 2016
  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 Subjects With Myeloma Undergoing Autologous Transplant

Resource links provided by NLM:


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 2017
Estimated Primary Completion Date: December 2017 (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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

SCREEN #1 (Visit 1) Step 1:

  • Diagnosis of symptomatic multiple myeloma.
  • Less than 10 months after initiation of systemic therapy.
  • One or two lines of induction therapy with commonly used regimens.
  • Age greater than or equal to 18 years to less than or equal to 70 years at the time of enrollment.
  • IgG paraprotein (not of IgG3 subtype) with a paraprotein peak (M-spike) of ≥0.2 g/dL. Alternatively subjects 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 actual or 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 or a creatinine clearance of 40cc/min or more.
  • Adequate hepatic function as defined by a total bilirubin of 2.0 mg/dl or less and AST and ALT 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 of child bearing potential and agree to use a medically acceptable form of birth control while on the study drugs.

Exclusion:

  • Subjects with melphalan-based induction
  • 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.
  • Concurrent use of systemic steroids at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy during Tcell collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of inhaled steroids is permitted as well.
  • Prior autologous or allogeneic transplant.

For this study, there will be no exceptions to eligibility granted.

4.2 PRE-VACCINE #1 ASSESSMENT (Visit 3) Step 2

Subjects must meet the following criteria to proceed with vaccination:

  • Less than 9 months from randomization.
  • Adequate renal function as defined by creatinine of 2.0 mg/dl or less or a creatinine clearance of 40cc/min or more.
  • Adequate hepatic function as defined by a total bilirubin of 2.0 mg/dl or less and AST and ALT less than 2 times upper limit of normal.
  • Karnofsky performance status of at least 80% or more.
  • At least 2 weeks from last chemotherapy.
  • Negative serum Beta HCG test in women of child bearing potential.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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         
United States, Texas
University of Texas, MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Muzaffar H Qazilbash, MD    713-792-2466    mqazilba@mdanderson.org   
Principal Investigator: Muzaffar H Qazilbash, 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
Principal Investigator: Muzaffar H. Qazilbash, MD M.D. Anderson Cancer Center
  More Information

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: January 12, 2016
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
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2016