Status:
COMPLETED
Id-KLH Vaccine + T Cells in Subjects With Myeloma Undergoing Transplant
Lead Sponsor:
University of Pennsylvania
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
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/...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01426828
Start Date
August 1 2011
End Date
December 1 2017
Last Update
December 4 2020
Active Locations (2)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
2
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030