Status:
COMPLETED
Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma
Lead Sponsor:
University of Pennsylvania
Conditions:
Myeloma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 m...
Detailed Description
Autologous stem cell transplant (ASCT) can lead to a complete or partial disappearance of the myeloma in about 2 out of 3 patients. However, an ASCT only sometimes leads to a cure of the myeloma. In a...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
May 10 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01245673
Start Date
May 10 2011
End Date
December 1 2018
Last Update
April 6 2020
Active Locations (2)
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1
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
2
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104