Overview

Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma

Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
0
Participant gender:
All
Summary
One purpose of this study is to find out if a new combination of immune system treatments (MAGE-A3 vaccine plus activated T-cells) will allow the body to build up protection ("immunity") against the myeloma cells. A second purpose is to find out how well this combination of immune system treatments is able to control the myeloma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Pennsylvania
Treatments:
Carboxymethylcellulose Sodium
Heptavalent Pneumococcal Conjugate Vaccine
Lenalidomide
Poly I-C
Poly ICLC
Thalidomide
Vaccines
Criteria
Inclusion Criteria:

- Written informed consent

- Patients must be registered with the Sponsor's Monitor

- Patients must have a diagnosis of myeloma

- Patients must meet one of the following criteria:

1. Myeloma has relapsed, progressed, or failed to respond after at least one prior
course of therapy (consisting of at least 2 treatment cycles or months of
therapy).

2. Myeloma has responded partially to initial therapy but a complete response
(immunofixation negative and normal serum free light chain studies)has NOT
developed after a minimum of 3 cycles or months of initial therapy.

3. Myeloma has high-risk features as defined by the presence of one or more
cytogenetic abnormalities known to confer a poor outcome even after standard
autotransplants:complex karyotype (> or = to 3
abnormalities),t(4;14),t(14;16),del (17)(p13.1),and/or chromosome 13
abnormalities.

- Patients must have measurable disease on study entry

- Patients must be between ages 18-80 (inclusive).

- Patients should have adequate vital organ function as defined by the protocol.

- ECOG performance status 0-2 (unless due solely to bone pain)

- Prior to Lenalidomide maintenance phase, all study participants must be registered
into the mandatory RevAssist® program, and be willing and able to comply with the
requirements of RevAssist®.

- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
test as per the protocol

- Lenalidomide treatment phase: able to take aspirin (81 or 325 mg) daily as
prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low
molecular weight heparin).

Exclusion Criteria:

- Pregnant or nursing females

- HIV or HTLV-1/2 seropositivity

- Known history of myelodysplasia

- Known history of chronic active hepatitis or liver cirrhosis (if suspected by
laboratory studies, should be confirmed by liver biopsy).

- Active Hepatitis B (as defined by + Hepatitis B surface antigen); + Hepatitis C virus
(HCV) antibody is NOT an exclusion

- Prior autotransplant or allogeneic transplant

- More than 4 distinct, prior courses of therapy for myeloma

- History of severe autoimmune disease requiring steroids or other immunosuppressive
treatments.

- Active immune-mediated diseases including:connective tissue diseases,
uveitis,sarcoidosis,inflammatory bowel disease, multiple sclerosis.

- Evidence or history of other significant cardiac,hepatic,renal,
ophthalmologic,psychiatric,or gastrointestinal disease which would likely increase the
risks of participating in the study

- Active bacterial, viral or fungal infections.