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Report for Clinical Trial NCT00834665

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase I/II Combination Immunotherapy After ASCT for Advanced Myeloma to Study HTERT Vaccination Followed by Adoptive Transfer of Vaccine-Primed Autologous T Cells

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.

NCT00834665 Multiple Myeloma
MeSH: Multiple Myeloma Neoplasms, Plasma Cell
HPO: Multiple myeloma

2 Interventions

Name: hTERT vaccine, GM-CSF, PCV, T cell infusion

Description: hTERT vaccine (multi-peptide vaccine), Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), Prevnar-Pneumococcal Conjugate vaccine (PCV), T cell infusion

Type: Biological

hTERT/GM-CSF+PCV, T cell infusion

Name: GM-CSF, PCV, T cell infusion

Description: Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), Prevnar-Pneumococcal Conjugate vaccine (PCV), T cell infusion

Type: Biological

GM-CSF+PCV, T cell infusion,GM-CSF+PVC


Primary Outcomes

Description: Incidence of delayed hematopoietic recovery and the incidence of Grade 3 or greater autoimmune events

Measure: Primary toxicity endpoint

Time: 2 yrs

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 D988Y

The two investigational products to be evaluated in this Phase I/II study include: 1. hTERT Vaccine (the putative tumor vaccine)- a multi-peptide vaccine consisting of 3 peptides against the catalytic subunit of telomerase (hTERT D988Y, I540, and R572Y), 1 survivin peptide (Sur1M2- an antiapoptotic protein), and 1 CMV (cytopeptide (N495). --- D988Y ---


2 R572Y

The two investigational products to be evaluated in this Phase I/II study include: 1. hTERT Vaccine (the putative tumor vaccine)- a multi-peptide vaccine consisting of 3 peptides against the catalytic subunit of telomerase (hTERT D988Y, I540, and R572Y), 1 survivin peptide (Sur1M2- an antiapoptotic protein), and 1 CMV (cytopeptide (N495). --- D988Y --- --- R572Y ---



HPO Nodes


HPO:
Multiple myeloma
Genes 3
LIG4 CCND1 GBA