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.