Multiple Myeloma Clinical Trial
Official title:
Phase I/II Combination Immunotherapy After ASCT for Advanced Myeloma to Study HTERT Vaccination Followed by Adoptive Transfer of Vaccine-Primed Autologous T Cells
Verified date | October 2019 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is:
1. To evaluate the safety of activated T cell infusions and immunization with hTERT
multi-peptide vaccine in the post-transplant setting and whether the combination can
delay hematopoietic recovery or induce other autoimmune events.
2. To determine whether the strategy of infusing vaccine-primed T-cells early after
transplant in conjunction with post-transplant boosters leads to the induction of
cellular immune responses to hTERT.
Status | Completed |
Enrollment | 59 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Each subject must meet ALL of the following criteria during screening to be enrolled in the
study: 1. Written informed consent must be obtained from all patients before entry into the study 2. Patients must have a diagnosis of myeloma 3. Patients must meet one of the following criteria: - Myeloma has relapsed, progressed, or failed to respond after at least one prior course of therapy. - Myeloma has responded partially to initial therapy but neither a complete nor a near-complete response has developed after at least 3 cycles or months of initial therapy. - Myeloma has high-risk features 4. Patients must have measurable disease on study entry. 5. Patients must be between ages 18-80 (inclusive). 6. Patients should have adequate vital organ function. 7. ECOG performance status 0-2 8. Women of child-bearing potential (WOCBP) and their spouses or partners must be willing to use adequate contraception for the duration of the active treatment phase of the study and for at least 4 months after the last dose of chemotherapy. In addition, contraceptive measures must be continued as long as the patient remains on maintenance thalidomide in accordance with the STEPS program. Key Exclusion Criteria Subjects who meet ANY of the following criteria cannot be enrolled in the study: 1. Pregnant or nursing females 2. HIV, HTLV-1/2 seropositivity 3. Known history of myelodysplasia 4. Known history of chronic active hepatitis or liver cirrhosis (if suspected by laboratory studies, should be confirmed by liver biopsy). 5. Active Hepatitis B 6. Prior autotransplant or allogeneic transplant 7. More than 4 distinct, prior courses of therapy for myeloma 8. History of severe autoimmune disease requiring steroids or other immunosuppressive treatments. 9. Active immune-mediated diseases including: connective tissue diseases, uveitis, sarcoidosis, inflammatory bowel disease, multiple sclerosis. 10. Evidence or history of other significant cardiac, hepatic, renal, ophthalmologic, psychiatric, or gastrointestinal disease which might increase the risks of participating in the study 11. Active bacterial, viral or fungal infections. |
Country | Name | City | State |
---|---|---|---|
United States | Greenbaum Cancer Center | Baltimore | Maryland |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | University of Maryland, College Park |
United States,
Rapoport AP, Aqui NA, Stadtmauer EA, Vogl DT, Fang HB, Cai L, Janofsky S, Chew A, Storek J, Akpek G, Badros A, Yanovich S, Tan MT, Veloso E, Pasetti MF, Cross A, Philip S, Murphy H, Bhagat R, Zheng Z, Milliron T, Cotte J, Cannon A, Levine BL, Vonderheide RH, June CH. Combination immunotherapy using adoptive T-cell transfer and tumor antigen vaccination on the basis of hTERT and survivin after ASCT for myeloma. Blood. 2011 Jan 20;117(3):788-97. doi: 10.1182/blood-2010-08-299396. Epub 2010 Oct 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary toxicity endpoint | Incidence of delayed hematopoietic recovery and the incidence of Grade 3 or greater autoimmune events | 2 yrs |
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