Randomized Phase II Trial of CD3/CD28 Activated Id-KLH Primed Autologous Lymphocytes in Patients With Myeloma Undergoing Autologous Transplant
18 Years
N/A
Both
Multiple Myeloma
Trial Information
Randomized Phase II Trial of CD3/CD28 Activated Id-KLH Primed Autologous Lymphocytes in Patients With Myeloma Undergoing Autologous Transplant
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Outcome Measure:
Adverse Events
Safety Issue:
Yes
Principal Investigator
Ed Stadtmauer, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Abramson Cancer Center of the University of Pennsylvania
Authority:
United States: Food and Drug Administration
Study ID:
UPCC 07409
NCT ID:
NCT01426828
Start Date:
August 2011
Completion Date:
December 2013
Related Keywords:
- Multiple Myeloma
- adult
- symptomatic multiple myeloma
- myeloma
- diagnosis within 12 months of initiation of systemic therapy
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
