Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma

Completed · Phase 2

Conditions studied: Myeloma

In brief

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.

Key facts

Study ID

NCT01245673

Run by

University of Pennsylvania

People needed

28

Starts

2011-05-10

Expected to finish

2018-12-01

Last updated by the study team

2020-04-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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).
• 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.
• 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).

You may not qualify if…

• 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.

Where it is running

• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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