Id-KLH Vaccine + T Cells
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
adult, symptomatic multiple myeloma, myeloma, diagnosis within 12 months of initiation of systemic therapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Intervention
Name: CD3/CD28
Type: Biological
Overall Status
Recruiting
Summary
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Ed Stadtmauer, MD - 855-216-0098 - PennCancerTrials@emergingmed.com
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: Muzaffar H Qazilbash, MD - 713-792-2466 - mqazilba@mdanderson.org
Start Date
August 2011
Completion Date
December 2015
Sponsors
Abramson Cancer Center of the University of Pennsylvania
Source
Abramson Cancer Center of the University of Pennsylvania
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page